europeanpharmacopoeia9.7 index · europeanpharmacopoeia9.7 index to aid users the index includes a...

EUROPEAN PHARMACOPOEIA 9.7

INDEXTo aid users the index includes a reference to the supplement in which the latest version of a text can be found.For example : Alfuzosin hydrochloride...............................................9.1‑4123means the monograph Alfuzosin hydrochloride can be found on page 4123 of Supplement 9.1.Note that where no reference to a supplement is made, the text can be found in the principal volume.

English index ..................................................................... 6693 Latin index .............................................................................. 6729

General Notices (1) apply to all monographs and other texts 6691

EUROPEAN PHARMACOPOEIA 9.7

6692 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.7 Index

Numerics1. General notices ............................................................ 9.2-42752.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes................................................. 9.3-46852.1. Apparatus ............................................................................. 152.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method...................... 9.1-40372.2.15. Melting point - open capillary method ....................... 322.2.16. Melting point - instantaneous method........................ 332.2.17. Drop point ........................................................... 9.6-58192.2.18. Freezing point................................................................. 342.2.19. Amperometric titration................................................. 352.2.1. Clarity and degree of opalescence of liquids ..... 9.2-42852.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry..................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................. 372.2.24. Absorption spectrophotometry, infrared.........9.7-62852.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 41

2.2.26. Paper chromatography .................................................. 422.2.27. Thin-layer chromatography.......................................... 432.2.28. Gas chromatography........................................... 9.6-58212.2.29. Liquid chromatography...................................... 9.6-58222.2.2. Degree of coloration of liquids....................................... 222.2.30. Size-exclusion chromatography ........................ 9.6-58232.2.31. Electrophoresis ............................................................... 482.2.32. Loss on drying..................................................... 9.4-50992.2.33. Nuclear magnetic resonance spectrometry ................ 542.2.34. Thermal analysis ............................................................ 572.2.35. Osmolality....................................................................... 592.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 60

2.2.37. X-ray fluorescence spectrometry ......................9.3-46892.2.38. Conductivity ........................................................ 9.6-58242.2.39. Molecular mass distribution in dextrans .................... 622.2.3. Potentiometric determination of pH............................. 242.2.40. Near-infrared spectroscopy .......................................... 642.2.41. Circular dichroism......................................................... 692.2.42. Density of solids............................................................. 702.2.43. Mass spectrometry......................................................... 712.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 73

2.2.45. Supercritical fluid chromatography ............................. 742.2.46. Chromatographic separation techniques .........9.2-42862.2.47. Capillary electrophoresis............................................... 812.2.48. Raman spectroscopy...................................................... 862.2.49. Falling ball and automatic rolling ball viscometermethods .......................................................................... 9.3-4690

2.2.4. Approximate pH of solutions ......................................... 252.2.54. Isoelectric focusing ........................................................ 892.2.55. Peptide mapping ............................................................ 902.2.56. Amino acid analysis............................................ 9.3-46912.2.57. Inductively coupled plasma-atomic emissionspectrometry ........................................................................... 100

2.2.58. Inductively coupled plasma-mass spectrometry...... 1012.2.59. Glycan analysis of glycoproteins ................................ 1032.2.5. Relative density................................................................. 252.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 109

2.2.63. Direct amperometric and pulsed electrochemicaldetection ......................................................................... 9.7-6288

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 112

2.2.65. Voltametric titration .................................................... 112

2.2.66. Detection and measurement of radioactivity ........... 1132.2.6. Refractive index................................................................ 262.2.7. Optical rotation ..................................................... 9.5-55352.2.8. Viscosity ................................................................. 9.4-50992.2.9. Capillary viscometer method .............................. 9.6-58192.2. Physical and physicochemical methods ........................... 212.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 123

2.3.2. Identification of fatty oils by thin-layerchromatography............................................................. 9.6-5829

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 127

2.3.4. Odour .............................................................................. 1272.3. Identification...................................................................... 1232.4.10. Lead in sugars............................................................... 1362.4.11. Phosphates .................................................................... 1362.4.12. Potassium...................................................................... 1362.4.13. Sulfates........................................................................... 1362.4.14. Sulfated ash ................................................................... 1362.4.15. Nickel in polyols........................................................... 1372.4.16. Total ash ........................................................................ 1372.4.17. Aluminium ................................................................... 1372.4.18. Free formaldehyde ....................................................... 1372.4.19. Alkaline impurities in fatty oils.................................. 1382.4.1. Ammonium .................................................................... 1312.4.20. Determination of elemental impurities............ 9.6-58332.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 141

2.4.22. Composition of fatty acids by gas chromatography.. 1412.4.23. Sterols in fatty oils........................................................ 1442.4.24. Identification and control of residual solvents ......... 1462.4.25. Ethylene oxide and dioxan.......................................... 1512.4.26. N,N-Dimethylaniline ................................................... 1522.4.27. Heavy metals in herbal drugs and herbal drugpreparations ............................................................................ 152

2.4.28. 2-Ethylhexanoic acid ................................................... 1542.4.29. Composition of fatty acids in oils rich in omega-3acids................................................................................. 9.7-6293

2.4.2. Arsenic.................................................................... 9.4-51032.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 157

2.4.31. Nickel in hydrogenated vegetable oils .............. 9.4-51032.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1572.4.3. Calcium ........................................................................... 1322.4.4. Chlorides ......................................................................... 1322.4.5. Fluorides.......................................................................... 1322.4.6. Magnesium ..................................................................... 1322.4.7. Magnesium and alkaline-earth metals ........................ 1332.4.8. Heavy metals................................................................... 1332.4.9. Iron .................................................................................. 1362,4-Dichlorobenzyl alcohol ................................................... 22422.4. Limit tests........................................................................... 1312.5.10. Oxygen-flask method .................................................. 1642.5.11. Complexometric titrations.......................................... 1642.5.12. Water : semi-micro determination .................... 9.4-51072.5.13. Aluminium in adsorbed vaccines .............................. 1652.5.14. Calcium in adsorbed vaccines .................................... 1662.5.15. Phenol in immunosera and vaccines......................... 1662.5.16. Protein in polysaccharide vaccines ............................ 1662.5.17. Nucleic acids in polysaccharide vaccines .................. 1662.5.18. Phosphorus in polysaccharide vaccines .................... 1662.5.19. O-Acetyl in polysaccharide vaccines ......................... 1672.5.1. Acid value........................................................................ 1612.5.20. Hexosamines in polysaccharide vaccines.................. 1672.5.21. Methylpentoses in polysaccharide vaccines.............. 1672.5.22. Uronic acids in polysaccharide vaccines ................... 1682.5.23. Sialic acid in polysaccharide vaccines ....................... 1682.5.24. Carbon dioxide in gases .............................................. 1682.5.25. Carbon monoxide in gases ......................................... 1692.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1702.5.27. Oxygen in gases............................................................ 1702.5.28. Water in gases............................................................... 1702.5.29. Sulfur dioxide ............................................................... 171


Index EUROPEAN PHARMACOPOEIA 9.7

2.5.2. Ester value....................................................................... 1612.5.30. Oxidising substances ................................................... 1712.5.31. Ribose in polysaccharide vaccines ............................. 1712.5.32. Water : micro determination.............................. 9.4-51072.5.33. Total protein ................................................................. 1722.5.34. Acetic acid in synthetic peptides................................ 1752.5.35. Nitrous oxide in gases ................................................. 1762.5.36. Anisidine value............................................................. 1762.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 176

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 177

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 178

2.5.3. Hydroxyl value ............................................................... 1612.5.40. Methyl, ethyl and isopropyl toluenesulfonate in activesubstances ................................................................................ 179

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in activesubstances ................................................................................ 180

2.5.4. Iodine value .................................................................... 1612.5.5. Peroxide value................................................................. 1622.5.6. Saponification value....................................................... 1632.5.7. Unsaponifiable matter ................................................... 1632.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 163

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 164

2.5. Assays ................................................................................. 1612.6.10. Histamine...................................................................... 1942.6.11. Depressor substances................................................... 1952.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 195

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 199

2.6.14. Bacterial endotoxins ........................................... 9.3-47072.6.15. Prekallikrein activator ................................................. 2082.6.16. Tests for extraneous agents in viral vaccines for humanuse.................................................................................... 9.4-5111

2.6.17. Test for anticomplementary activity ofimmunoglobulin............................................................ 9.3-4713

2.6.18. Test for neurovirulence of live virus vaccines .......... 2122.6.1. Sterility ............................................................................ 1852.6.20. Anti-A and anti-B haemagglutinins .......................... 2132.6.21. Nucleic acid amplification techniques....................... 2142.6.22. Activated coagulation factors ..................................... 2192.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 219

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 222

2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 225

2.6.27. Microbiological examination of cell-basedpreparations ................................................................... 9.2-4297

2.6.2. Mycobacteria .................................................................. 1882.6.30. Monocyte-activation test.................................... 9.2-42992.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 232

2.6.33. Residual pertussis toxin and irreversibility of pertussistoxoid ....................................................................................... 235

2.6.34. Host-cell protein assays...................................... 9.1-40412.6.36. Microbiological examination of live biotherapeuticproducts : tests for enumeration of microbialcontaminants.................................................................. 9.7-6297

2.6.38. Microbiological examination of live biotherapeuticproducts : tests for specified micro-organisms........... 9.7-6301

2.6.7. Mycoplasmas .................................................................. 1882.6.8. Pyrogens.......................................................................... 1932.6. Biological tests ................................................................... 1852.7.10. Assay of human coagulation factor VII .................... 2582.7.11. Assay of human coagulation factor IX ...................... 2592.7.12. Assay of heparin in coagulation factors .................... 2592.7.13. Assay of human anti-D immunoglobulin ................. 260

2.7.14. Assay of hepatitis A vaccine .............................. 9.7-63142.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2632.7.16. Assay of pertussis vaccine (acellular) ........................ 2632.7.17. Assay of human antithrombin III .............................. 2652.7.18. Assay of human coagulation factor II ....................... 2662.7.19. Assay of human coagulation factor X........................ 2662.7.1. Immunochemical methods........................................... 2392.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2672.7.21. Assay of human von Willebrand factor..................... 2682.7.22. Assay of human coagulation factor XI ...................... 2692.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products ....................................................... 269

2.7.24. Flow cytometry ............................................................ 2712.7.25. Assay of human plasmin inhibitor............................. 2722.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 273

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 274

2.7.29. Nucleated cell count and viability.............................. 2752.7.2. Microbiological assay of antibiotics.................... 9.7-63092.7.30. Assay of human protein C .......................................... 2762.7.31. Assay of human protein S ........................................... 2772.7.32. Assay of human α-1-proteinase inhibitor ................. 2782.7.34. Assay of human C1-esterase inhibitor ...................... 2782.7.35. Immunonephelometry for vaccine componentassay ......................................................................................... 279

2.7.4. Assay of human coagulation factor VIII ..................... 2462.7.5. Assay of heparin.................................................... 9.1-40492.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2472.7.7. Assay of pertussis vaccine (whole cell)........................ 2522.7.8. Assay of tetanus vaccine (adsorbed)............................ 2532.7.9. Test for Fc function of immunoglobulin............ 9.3-47242.7. Biological assays ................................................................ 2392.8.10. Solubility in alcohol of essential oils.......................... 2842.8.11. Assay of 1,8-cineole in essential oils.......................... 2852.8.12. Essential oils in herbal drugs...................................... 2852.8.13. Pesticide residues ................................................ 9.6-58392.8.14. Tannins in herbal drugs .............................................. 2882.8.15. Bitterness value............................................................. 2882.8.16. Dry residue of extracts ................................................ 2892.8.17. Loss on drying of extracts........................................... 2892.8.18. Determination of aflatoxin B1 in herbal drugs ......... 2892.8.1. Ash insoluble in hydrochloric acid .............................. 2832.8.20. Herbal drugs : sampling and sample preparation .... 2912.8.21. Test for aristolochic acids in herbal drugs ................ 2922.8.22. Determination of ochratoxin A in herbal drugs ...... 2942.8.23. Microscopic examination of herbal drugs ................ 2952.8.25. High-performance thin-layer chromatography ofherbal drugs and herbal drug preparations ........................ 295

2.8.2. Foreign matter ................................................................ 2832.8.3. Stomata and stomatal index.......................................... 2832.8.4. Swelling index................................................................. 2842.8.5. Water in essential oils .................................................... 2842.8.6. Foreign esters in essential oils ...................................... 2842.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 284

2.8.8. Odour and taste of essential oils .................................. 2842.8.9. Residue on evaporation of essential oils ..................... 2842.8. Methods in pharmacognosy ............................................ 2832.9.10. Ethanol content ............................................................ 3152.9.11. Test for methanol and 2-propanol ............................. 3182.9.12. Sieve test........................................................................ 3192.9.14. Specific surface area by air permeability.......... 9.1-40532.9.16. Flowability..................................................................... 3212.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 322

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 323

2.9.19. Particulate contamination : sub-visible particles...... 3352.9.1. Disintegration of tablets and capsules ......................... 2992.9.20. Particulate contamination : visible particles ............. 3372.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 338



2.9.23. Gas pycnometric density of solids .................... 9.7-63192.9.25. Dissolution test for medicated chewing gums ......... 3402.9.26. Specific surface area by gas adsorption ..................... 3442.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 347

2.9.29. Intrinsic dissolution..................................................... 3472.9.2. Disintegration of suppositories and pessaries ............ 3012.9.31. Particle size analysis by laser light diffraction.. 9.7-63202.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 352

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) .............. 9.7-6323

2.9.34. Bulk density and tapped density of powders... 9.7-63282.9.35. Powder fineness................................................... 9.7-63312.9.36. Powder flow .................................................................. 3622.9.37. Optical microscopy...................................................... 3652.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 367

2.9.39. Water-solid interactions : determinationof sorption-desorption isotherms and of wateractivity............................................................................. 9.7-6331

2.9.3. Dissolution test for solid dosage forms ....................... 3022.9.40. Uniformity of dosage units ................................ 9.1-40552.9.41. Friability of granules and spheroids .......................... 3752.9.42. Dissolution test for lipophilic solid dosage forms ... 3772.9.43. Apparent dissolution ................................................... 3772.9.44. Preparations for nebulisation : characterisation....... 3782.9.45. Wettability of porous solids including powders....... 3812.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 384

2.9.4. Dissolution test for transdermal patches .................... 3092.9.5. Uniformity of mass of single-dose preparations ........ 3112.9.6. Uniformity of content of single-dose preparations.... 3122.9.7. Friability of uncoated tablets ........................................ 3122.9.8. Resistance to crushing of tablets .................................. 3132.9.9. Measurement of consistency by penetrometry .......... 3132.9. Pharmaceutical technical procedures ............................. 2993.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 410

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for solid dosage forms for oraladministration......................................................................... 412

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components.. 9.6-5843

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents .................................................................... 9.6-5846

3.1.13. Plastic additives ................................................... 9.6-58493.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ........................................................................... 9.6-5852

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 419

3.1.1. Materials for containers for human blood and bloodcomponents ............................................................................. 391

3.1.3. Polyolefins .............................................................. 9.4-51173.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations ................................................................... 9.2-4310

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations .......... 9.4-5120

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ................ 9.4-5123

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ................. 9.2-4318

3.1.8. Silicone oil used as a lubricant ..................................... 4083.1.9. Silicone elastomer for closures and tubing ................. 4093.1. Materials used for the manufacture of containers ........ 3913.2.1. Glass containers for pharmaceutical use............ 9.6-58593.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 429

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 428

3.2.3. Sterile plastic containers for human blood andblood components ......................................................... 9.6-5865

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components.. 9.6-5866

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ...... 9.6-5868

3.2.6. Sets for the transfusion of blood and bloodcomponents ............................................................................. 433

3.2.8. Sterile single-use plastic syringes ................................. 4343.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders..................................................... 9.5-5545

3.2. Containers.......................................................................... 4233-O-Desacyl-4-monophosphoryl lipid A............................ 22074.1.1. Reagents .................................................................9.7-63374.1.2. Standard solutions for limit tests ........................ 9.7-64544.1.3. Buffer solutions ..................................................... 9.7-64584.1. Reagents, standard solutions, buffer solutions ..... 9.7-63374.2.1. Primary standards for volumetric solutions ...... 9.7-64654.2.2. Volumetric solutions............................................. 9.7-64654.2. Volumetric analysis.................................................. 9.7-64654-Aminobenzoic acid ............................................................. 17024. Reagents........................................................................ 9.7-63375.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 723

5.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 593

5.1.11. Determination of bactericidal, fungicidal or yeasticidalactivity of antiseptic medicinal products.................... 9.2-4348

5.11. Characters section in monographs ............................... 7295.1.1. Methods of preparation of sterile products ....... 9.2-43335.1.2. Biological indicators and related microbial preparationsused in the manufacture of sterile products............... 9.2-4336

5.12. Reference standards ............................................... 9.5-55635.1.3. Efficacy of antimicrobial preservation ........................ 5775.14. Gene transfer medicinal products for humanuse.................................................................................... 9.7-6497

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceuticaluse.................................................................................... 9.7-6473

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 580

5.15. Functionality-related characteristics ofexcipients ........................................................................ 9.2-4411

5.1.6. Alternative methods for control of microbiologicalquality ............................................................................. 9.2-4339

5.16. Crystallinity ..................................................................... 7575.17.1. Recommendations on dissolution testing................. 7615.17. Recommendations on methods for dosage formstesting....................................................................................... 761

5.1.7. Viral safety ...................................................................... 5915.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation ......... 9.7-6474

5.19. Extemporaneous preparation of radiopharmaceuti-cals ............................................................................................ 767

5.1.9. Guidelines for using the test for sterility..................... 5925.1. General texts on microbiology ........................................ 5755.20. Elemental impurities ............................................. 9.3-47595.2.11. Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use............................... 626

5.2.12. Raw materials of biological origin for the productionof cell-based and gene therapy medicinal products ........... 627

5.2.13. Healthy chicken flocks for the production of inactivatedvaccines for veterinary use .................................................... 630

5.2.14. Substitution of in vivo method(s) by in vitromethod(s)for the quality control of vaccines ............................... 9.3-4737

5.21. Chemometric methods applied to analytical data ...... 7835.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 599

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 599

5.22. Names of herbal drugs used in traditional Chinesemedicine ......................................................................... 9.7-6511



5.2.3. Cell substrates for the production of vaccines for humanuse.................................................................................... 9.3-4733

5.23. Monographs on herbal drug extracts (informationchapter) ........................................................................... 9.7-6515

5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 606

5.24. Chemical imaging .................................................. 9.6-58975.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 608

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 610

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 612

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 613

5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 625

5.2. General texts on biological products .............................. 5995.3. Statistical analysis of results of biological assays andtests.................................................................................. 9.2-4353

5.4. Residual solvents ...................................................... 9.5-55535.5. Alcoholimetric tables........................................................ 6755.6. Assay of interferons .......................................................... 6895.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ............. 9.2-4385

5.8. Pharmacopoeial harmonisation ............................. 9.7-64775.9. Polymorphism ................................................................... 719

AAbacavir sulfate....................................................................... 1619Abbreviations and symbols (1.) ..................................... 9.2-4275Absorption spectrophotometry, infrared (2.2.24.) ...... 9.7-6285Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 41

Acacia ....................................................................................... 1229Acacia, spray-dried ................................................................. 1620Acamprosate calcium ............................................................. 1621Acanthopanax bark ......................................................... 9.2-4447Acarbose .................................................................................. 1622Acebutolol hydrochloride ...................................................... 1624Aceclofenac....................................................................... 9.3-4835Acemetacin .............................................................................. 1628Acesulfame potassium............................................................ 1629Acetate trihydrate, sodium .................................................... 3558Acetazolamide......................................................................... 1630Acetic acid, glacial .................................................................. 1632Acetic acid in synthetic peptides (2.5.34.) ............................. 175Acetone ............................................................................. 9.7-6561Acetylcholine chloride ........................................................... 1633Acetylcysteine.......................................................................... 1634β-Acetyldigoxin....................................................................... 1635Acetylene intermix (1 per cent) in nitrogen................. 9.3-4836Acetylsalicylic acid ................................................................. 1638Acetyltryptophan, N- ............................................................. 1639Acetyltyrosine, N- ................................................................... 1641Achyranthes bidentata root ............................................ 9.7-6541Aciclovir................................................................................... 1642Acidum picrinicum for homoeopathic preparations ......... 1587Acidum succinicum for homoeopathic preparations.. 9.5-5621Acid value (2.5.1.) ..................................................................... 161Acitretin ............................................................................9.5-5627Actinobacillosis vaccine (inactivated), porcine .................. 1085Activated charcoal .................................................................. 2025Activated coagulation factors (2.6.22.)................................... 219Adapalene ................................................................................ 1646Additives, plastic (3.1.13.) .............................................. 9.6-5849Adenine.................................................................................... 1647Adeno-associated-virus vectors for human use .................... 748Adenosine ................................................................................ 1648Adenovirus vaccine (inactivated), canine............................ 1027Adenovirus vaccine (live), canine......................................... 1028

Adipic acid............................................................................... 1649Adrenaline ............................................................................... 1650Adrenaline tartrate ................................................................. 1652Adsorption, gas, specific surface area by (2.9.26.)................ 344Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 323

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 289Agar .......................................................................................... 1230Agaricus phalloides for homoeopathic preparations .. 9.5-5621Agnus castus fruit ................................................................... 1231Agnus castus fruit dry extract ............................................... 1232Agrimony................................................................................. 1233Air, medicinal ......................................................................... 1653Air, synthetic medicinal......................................................... 1655Akebia stem ...................................................................... 9.6-5985Alanine..................................................................................... 1656Albendazole...................................................................... 9.6-6009Albumin solution, human ..................................................... 2660Alchemilla................................................................................ 1235Alcoholimetric tables (5.5.) ..................................................... 675Alcuronium chloride.............................................................. 1658Alendronate trihydrate, sodium ........................................... 3559Alexandrian senna pods ........................................................ 1518Alfacalcidol.............................................................................. 1660Alfadex .............................................................................. 9.3-4838Alfentanil hydrochloride hydrate .................................. 9.7-6562Alfuzosin hydrochloride ................................................. 9.1-4123Alginate, sodium..................................................................... 3560Alginic acid.............................................................................. 1665Alimemazine hemitartrate..................................................... 1666Alkaline-earth metals and magnesium (2.4.7.)..................... 133Alkaline impurities in fatty oils (2.4.19.) ............................... 138Allantoin .................................................................................. 1667Allergen products ............................................................9.6-5905Allergen products, animal epithelia and outgrowths for... 1736Allergen products, Hymenoptera venoms for..................... 2732Allergen products, mites for.................................................. 3077Allergen products, moulds for .............................................. 3094Allergen products, pollens for............................................... 3362Allium sativum for homoeopathic preparations ................ 1590Allopurinol .............................................................................. 1668all-rac-α-Tocopherol............................................................... 3800all-rac-α-Tocopheryl acetate.................................................. 3802Almagate .................................................................................. 1670Almond oil, refined ................................................................ 1671Almond oil, virgin .................................................................. 1671Aloes, Barbados ...................................................................... 1236Aloes, Cape.............................................................................. 1237Aloes dry extract, standardised............................................. 1238Alovudine (18F) injection ....................................................... 1127Alphacyclodextrin ........................................................... 9.3-4838Alprazolam .............................................................................. 1672Alprenolol hydrochloride ...................................................... 1674Alprostadil ............................................................................... 1675Alteplase for injection ............................................................ 1677Alternative methods for control of microbiological quality(5.1.6.) ............................................................................. 9.2-4339

Altizide..................................................................................... 1681Alum......................................................................................... 1682Aluminium (2.4.17.)................................................................. 137Aluminium chloride hexahydrate......................................... 1682Aluminium hydroxide, hydrated, for adsorption ............... 1682Aluminium in adsorbed vaccines (2.5.13.)............................ 165Aluminium magnesium silicate ..................................... 9.3-4839Aluminium oxide, hydrated .................................................. 1684Aluminium phosphate gel ..................................................... 1685Aluminium phosphate, hydrated.......................................... 1686Aluminium sodium silicate ................................................... 1686Aluminium stearate................................................................ 1687Aluminium sulfate.................................................................. 1689Alverine citrate................................................................. 9.3-4841Amantadine hydrochloride ................................................... 1691Ambroxol hydrochloride ................................................ 9.2-4499



Amfetamine sulfate ......................................................... 9.7-6563Amidotrizoate, sodium .......................................................... 3561Amidotrizoic acid dihydrate ................................................. 1694Amikacin ................................................................................. 1696Amikacin sulfate .............................................................. 9.6-6010Amiloride hydrochloride dihydrate .............................. 9.7-6564Amino acid analysis (2.2.56.) ......................................... 9.3-4691Aminobenzoic acid, 4- ........................................................... 1702Aminocaproic acid ................................................................. 1703Aminoglutethimide ................................................................ 1704Aminophylline ........................................................................ 3752Aminophylline hydrate .......................................................... 3754Aminosalicylate dihydrate, sodium...................................... 3562Amiodarone hydrochloride................................................... 1706Amisulpride...................................................................... 9.6-6013Amitriptyline hydrochloride ................................................. 1709Amlodipine besilate................................................................ 1710Ammonia (13N) injection....................................................... 1129Ammonia solution, concentrated ......................................... 1712Ammonio methacrylate copolymer (type A)............... 9.6-6014Ammonio methacrylate copolymer (type B) ............... 9.6-6015Ammonium (2.4.1.).................................................................. 131Ammonium bromide ............................................................. 1714Ammonium carbonicum for homoeopathic preparations.. 9.3-4827

Ammonium chloride.............................................................. 1715Ammonium glycyrrhizate ..................................................... 1716Ammonium hydrogen carbonate ......................................... 1717Amobarbital ............................................................................ 1717Amobarbital sodium .............................................................. 1718Amomum fruit........................................................................ 1239Amomum fruit, round ........................................................... 1502Amorolfine hydrochloride.............................................. 9.7-6566Amoxicillin sodium................................................................ 1720Amoxicillin trihydrate............................................................ 1723Amperometric detection, direct, and pulsed electrochemicaldetection (2.2.63.) .......................................................... 9.7-6288

Amperometric titration (2.2.19.) .............................................. 35Amphotericin B ...................................................................... 1725Ampicillin ................................................................................ 1727Ampicillin sodium.................................................................. 1729Ampicillin trihydrate.............................................................. 1731Amylmetacresol ...................................................................... 1733Anacardium for homoeopathic preparations...................... 1591Anaemia vaccine (live), chicken, infectious ................. 9.5-5598Anaesthetic ether .................................................................... 2422Analysis, thermal (2.2.34.)......................................................... 57Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 367

Anamirta cocculus for homoeopathic preparations .......... 1597Anastrozole....................................................................... 9.3-4842Andrographis herb .......................................................... 9.3-4807Anemarrhena asphodeloides rhizome ................................. 1241Angelica archangelica root .................................................... 1242Angelica dahurica root.................................................... 9.3-4808Angelica pubescens root ................................................. 9.3-4810Angelica sinensis root ..................................................... 9.1-4100Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1741

Animal epithelia and outgrowths for allergen products.... 1736Animal immunosera for human use ............................. 9.6-5907Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 832

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613

Aniseed ............................................................................. 9.2-4448Anise oil ................................................................................... 1248Anisidine value (2.5.36.) .......................................................... 176Antazoline hydrochloride...................................................... 1737Anthrax spore vaccine (live) for veterinary use.................. 1003Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates).............................................................. 9.6-5919

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 213Antibiotics, microbiological assay of (2.7.2.) ............... 9.7-6309Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 225

Antibodies for human use, monoclonal ................................ 826Anticoagulant and preservative solutions for human blood................................................................................................ 1738

Anticomplementary activity of immunoglobulin(2.6.17.) ........................................................................... 9.3-4713

Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 225

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2663

Anti-D immunoglobulin, human ......................................... 2662Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 260Antimicrobial preservation, efficacy of (5.1.3.) .................... 577Antiseptic medicinal products, determination of bactericidal,fungicidal or yeasticidal activity of (5.1.11.) .............. 9.2-4348

Antiserum, European viper venom ...................................... 1119Antithrombin III concentrate, human................................. 2664Antithrombin III, human, assay of (2.7.17.) ......................... 265Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1741

Apis for homoeopathic preparations.................................... 1592Apomorphine hydrochloride hemihydrate ......................... 1744Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 377Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 580

Approximate pH of solutions (2.2.4.)....................................... 25Aprepitant................................................................................ 1746Aprotinin ..........................................................................9.6-6016Aprotinin concentrated solution ................................... 9.6-6018Arachis oil, hydrogenated............................................... 9.6-6021Arachis oil, refined .......................................................... 9.6-6022Arginine ................................................................................... 1753Arginine aspartate .................................................................. 1754Arginine hydrochloride ......................................................... 1755Argon ....................................................................................... 1756Aripiprazole............................................................................. 1757Aristolochic acids in herbal drugs, test for (2.8.21) ............. 292Arnica flower........................................................................... 1251Arnica tincture........................................................................ 1253Arsenic (2.4.2.) ................................................................. 9.4-5103Arsenicum album for homoeopathic preparations ..... 9.5-5623Arsenious trioxide for homoeopathic preparations .... 9.5-5623Articaine hydrochloride......................................................... 1758Artichoke leaf ................................................................... 9.4-5301Artichoke leaf dry extract ............................................... 9.4-5302Ascorbate, calcium ................................................................. 1911Ascorbate, sodium.................................................................. 3563Ascorbic acid .................................................................... 9.3-4843Ascorbyl palmitate.................................................................. 1762Ash insoluble in hydrochloric acid (2.8.1.) ........................... 283Ash leaf .................................................................................... 1257Ash, sulfated (2.4.14.)............................................................... 136Ash, total (2.4.16.) .................................................................... 137Asparagine monohydrate....................................................... 1762Aspartame................................................................................ 1763Aspartic acid..................................................................... 9.3-4845Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 285Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 247Assay of heparin (2.7.5.) ................................................. 9.1-4049Assay of heparin in coagulation factors (2.7.12.) ................. 259Assay of hepatitis A vaccine (2.7.14.)............................ 9.7-6314Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 263Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 278Assay of human anti-D immunoglobulin (2.7.13.) .............. 260Assay of human antithrombin III (2.7.17.)............................ 265Assay of human C1-esterase inhibitor (2.7.34.).................... 278Assay of human coagulation factor II (2.7.18.)..................... 266Assay of human coagulation factor IX (2.7.11.) ................... 259Assay of human coagulation factor VII (2.7.10.).................. 258



Assay of human coagulation factor VIII (2.7.4.) .................. 246Assay of human coagulation factor X (2.7.19.) ..................... 266Assay of human coagulation factor XI (2.7.22.) ................... 269Assay of human plasmin inhibitor (2.7.25.) .......................... 272Assay of human protein C (2.7.30.)........................................ 276Assay of human protein S (2.7.31.) ........................................ 277Assay of human von Willebrand factor (2.7.21.) .................. 268Assay of interferons (5.6.)........................................................ 689Assay of pertussis vaccine (acellular) (2.7.16.)...................... 263Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 252Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 267

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 253Assays (2.5.)............................................................................... 161Astragalus mongholicus root ......................................... 9.2-4449Atazanavir sulfate ............................................................ 9.7-6568Atenolol............................................................................. 9.1-4124Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .................................................................................... 100

Atomoxetine hydrochloride .................................................. 1767Atorvastatin calcium trihydrate ............................................ 1769Atovaquone.............................................................................. 1771Atractylodes lancea rhizome .......................................... 9.7-6542Atractylodes rhizome, largehead ................................... 9.7-6544Atracurium besilate ................................................................ 1772Atropine ............................................................................9.3-4847Atropine sulfate................................................................ 9.3-4849Aucklandia root ............................................................... 9.2-4450Aujeszky’s disease vaccine (inactivated) for pigs ................ 1003Aujeszky’s disease vaccine (live) for pigs for parenteraladministration....................................................................... 1005

Aurothiomalate, sodium........................................................ 3565Aurum chloratum natronatum for homoeopathicpreparations ................................................................... 9.5-5623

Automatic rolling ball and falling ball viscometer methods(2.2.49.) ...........................................................................9.3-4690

Avian infectious bronchitis vaccine (inactivated)............... 1007Avian infectious bronchitis vaccine (live)............................ 1008Avian infectious bursal disease vaccine (inactivated) ........ 1010Avian infectious bursal disease vaccine (live) ..................... 1011Avian infectious encephalomyelitis vaccine (live) .............. 1013Avian infectious laryngotracheitis vaccine (live)................ 1014Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 222

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .......................................................................... 1080

Avian paramyxovirus 1 (Newcastle disease) vaccine(live) ....................................................................................... 1082

Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1016Avian tuberculin purified protein derivative....................... 3862Avian viral tenosynovitis vaccine (live) ............................... 1017Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 219

Azaperone for veterinary use ................................................ 1778Azathioprine............................................................................ 1779Azelastine hydrochloride ....................................................... 1780Azithromycin ................................................................... 9.6-6022

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 214

Bacampicillin hydrochloride ................................................. 1787Bacitracin.......................................................................... 9.6-6029Bacitracin zinc.................................................................. 9.6-6033Baclofen ................................................................................... 1794Bacterial endotoxins (2.6.14.)......................................... 9.3-4707Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 593

Bactericidal, fungicidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Baical skullcap root ................................................................ 1262Bambuterol hydrochloride .................................................... 1795Barbados aloes ........................................................................ 1236Barbary wolfberry fruit................................................... 9.3-4812Barbital..................................................................................... 1797Barium chloratum for homoeopathic preparations ........... 1594Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1594

Barium sulfate ......................................................................... 1797Basic butylated methacrylate copolymer ...................... 9.4-5325BCG for immunotherapy......................................................... 894BCG vaccine, freeze-dried....................................................... 895Bearberry leaf .......................................................................... 1264Beclometasone dipropionate ................................................. 1799Beclometasone dipropionate monohydrate......................... 1802Beeswax, white ........................................................................ 1804Beeswax, yellow....................................................................... 1805Belamcanda chinensis rhizome............................................. 1266Belladonna for homoeopathic preparations................. 9.2-4492Belladonna leaf................................................................. 9.2-4452Belladonna leaf dry extract, standardised .................... 9.2-4453Belladonna leaf tincture, standardised.......................... 9.2-4454Belladonna, prepared ...................................................... 9.2-4456Benazepril hydrochloride ...................................................... 1806Bendroflumethiazide.............................................................. 1807Benperidol ............................................................................... 1808Benserazide hydrochloride .................................................... 1810Bentonite.................................................................................. 1811Benzalkonium chloride.......................................................... 1811Benzalkonium chloride solution........................................... 1813Benzathine benzylpenicillin tetrahydrate ..................... 9.6-6037Benzathine penicillin G tetrahydrate ............................ 9.6-6037Benzathine penicillin V tetrahydrate ............................ 9.6-6177Benzathine phenoxymethylpenicillin tetrahydrate ..... 9.6-6177Benzbromarone....................................................................... 1815Benzenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.41).................................................................. 180

Benzethonium chloride ......................................................... 1816Benzocaine........................................................................ 9.4-5326Benzoic acid ............................................................................ 1818Benzoin, Siam ......................................................................... 1272Benzoin, Sumatra.................................................................... 1273Benzoin tincture, Siam........................................................... 1274Benzoin tincture, Sumatra..................................................... 1274Benzoyl peroxide, hydrous .................................................... 1819Benzyl alcohol .................................................................. 9.4-5327Benzyl benzoate ...................................................................... 1822Benzylpenicillin (benzathine) tetrahydrate .................. 9.6-6037Benzylpenicillin potassium ............................................ 9.2-4505Benzylpenicillin, procaine .............................................. 9.2-4506Benzylpenicillin sodium ................................................. 9.2-4508Betacarotene ..................................................................... 9.7-6573Betacyclodextrin .............................................................. 9.3-4857Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2725Betacyclodextrin, sodium 4-sulfonatobutyl ether ....... 9.6-6215Betadex.............................................................................. 9.3-4857Betahistine dihydrochloride.................................................. 1831Betahistine mesilate................................................................ 1832Betamethasone ........................................................................ 1833Betamethasone acetate ........................................................... 1835Betamethasone dipropionate.......................................... 9.3-4858Betamethasone sodium phosphate....................................... 1839Betamethasone valerate ......................................................... 1840Betaxolol hydrochloride......................................................... 1842Bezafibrate ............................................................................... 1843Bicalutamide............................................................................ 1845Bifonazole ................................................................................ 1846Bilberry fruit, dried ......................................................... 9.6-5986Bilberry fruit dry extract, fresh, refined and standardised.. 9.7-6547

Bilberry fruit, fresh.......................................................... 9.6-5987



Biological assays (2.7.) ............................................................. 239Biological assays and tests, statistical analysis of results of(5.3.) ................................................................................ 9.2-4353

Biological indicators and related microbial preparations usedin the manufacture of sterile products (5.1.2.) .......... 9.2-4336

Biological products, general texts on (5.2.) ........................... 599Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 599

Biological tests (2.6.) ................................................................ 185Biotherapeutic products for human use, live ............... 9.7-6522Biotherapeutic products (live), microbiological examination of(tests for enumeration of microbial contaminants) (2.6.36.)......................................................................................... 9.7-6297

Biotherapeutic products (live), microbiological examinationof (tests for specified micro-organisms) (2.6.38.)...... 9.7-6301

Biotin................................................................................. 9.5-5631Biperiden hydrochloride........................................................ 1848Biphasic insulin injection ...................................................... 2770Biphasic isophane insulin injection...................................... 2770Birch leaf .................................................................................. 1276Bisacodyl .................................................................................. 1850Bismuth subcarbonate............................................................ 1851Bismuth subgallate.................................................................. 1852Bismuth subnitrate, heavy ..................................................... 1853Bismuth subsalicylate ............................................................. 1854Bisoprolol fumarate ................................................................ 1855Bistort rhizome ....................................................................... 1278Bitter fennel ............................................................................. 1352Bitter-fennel fruit oil .............................................................. 1279Bitter-fennel herb oil .............................................................. 1280Bitterness value (2.8.15.) .......................................................... 288Bitter-orange epicarp and mesocarp .................................... 1283Bitter-orange-epicarp and mesocarp tincture..................... 1284Bitter-orange flower................................................................ 1284Bitter-orange-flower oil.......................................................... 1449Black cohosh............................................................................ 1285Blackcurrant leaf ..................................................................... 1290Black horehound..................................................................... 1289Bleomycin sulfate.................................................................... 1857Blood and blood components, human, empty sterile containersof plasticised poly(vinyl chloride) for (3.2.4.)............ 9.6-5866

Blood and blood components, human, materials basedon plasticised poly(vinyl chloride) for containers for(3.1.1.1.) .......................................................................... 9.6-5843

Blood and blood components, human, materials for containersfor (3.1.1.) ................................................................................ 391

Blood and blood components, materials based on plasticisedpoly(vinyl chloride) for tubing used in sets for the transfusionof (3.1.1.2.)...................................................................... 9.6-5846

Blood and blood components, sets for the transfusion of(3.2.6.) ...................................................................................... 433

Blood and blood components, sterile plastic containers for(3.2.3.) ............................................................................. 9.6-5865

Blood, anticoagulant and preservative solutions for .......... 1738Blood, containing anticoagulant solution, human,sterile containers of plasticised poly(vinyl chloride)(3.2.5.) ............................................................................. 9.6-5868

Bogbean leaf ............................................................................ 1291Boiling point (2.2.12.) ................................................................ 31Boldine .............................................................................. 9.7-6574Boldo leaf ................................................................................. 1292Boldo leaf dry extract............................................................. 1293Borage (starflower) oil, refined ............................................. 1858Borax ........................................................................................ 1859Bordetella bronchiseptica vaccine (live) for dogs............... 1018Boric acid................................................................................. 1859Botulinum antitoxin ............................................................... 1115Botulinum toxin type A for injection ........................... 9.6-6039Botulinum toxin type B for injection............................ 9.6-6041Bovine insulin .................................................................. 9.3-4929Bovine leptospirosis vaccine (inactivated) .......................... 1019Bovine parainfluenza virus vaccine (live)............................ 1021Bovine respiratory syncytial virus vaccine (live) ................ 1022

Bovine rhinotracheitis vaccine (inactivated), infectious ... 1067Bovine rhinotracheitis vaccine (live), infectious ................ 1068Bovine serum .......................................................................... 1863Bovine tuberculin purified protein derivative..................... 3863Bovine viral diarrhoea vaccine (inactivated) ...................... 1023Brimonidine tartrate .............................................................. 1864Bromazepam ........................................................................... 1865Bromhexine hydrochloride............................................. 9.1-4137Bromocriptine mesilate.......................................................... 1868Bromperidol ............................................................................ 1870Bromperidol decanoate.......................................................... 1872Brompheniramine maleate .................................................... 1873Bronchitis vaccine (inactivated), infectious, avian ............. 1007Bronchitis vaccine (live), infectious, avian .......................... 1008Brotizolam ............................................................................... 1875Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use........................................................................ 1024

Buccal tablets and sublingual tablets............................. 9.3-4789Buckwheat herb ...................................................................... 1294Budesonide .............................................................................. 1876Bufexamac ............................................................................... 1878Buffer solutions (4.1.3.)................................................... 9.7-6458Buflomedil hydrochloride...................................................... 1879Bulk density and tapped density of powders (2.9.34.) .. 9.7-6328Bumetanide ............................................................................. 1881Bupivacaine hydrochloride.................................................... 1882Bupleurum root ............................................................... 9.4-5303Buprenorphine ........................................................................ 1884Buprenorphine hydrochloride .............................................. 1886Bursal disease vaccine (inactivated), infectious, avian....... 1010Bursal disease vaccine (live), infectious, avian.................... 1011Buserelin .................................................................................. 1887Buspirone hydrochloride ....................................................... 1889Busulfan ................................................................................... 1891Butcher’s broom...................................................................... 1296Butylated methacrylate copolymer, basic ..................... 9.4-5325Butylhydroxyanisole ............................................................... 1893Butylhydroxytoluene .............................................................. 1894Butyl parahydroxybenzoate................................................... 1892

CCabergoline ............................................................................. 1897Cachets.............................................................................. 9.4-5288Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1596

Cadmium sulfuricum for homoeopathic preparations...... 1596Caffeine .................................................................................... 1898Caffeine monohydrate............................................................ 1899Calcifediol monohydrate ................................................ 9.6-6045Calcipotriol....................................................................... 9.6-6046Calcipotriol monohydrate .............................................. 9.6-6048Calcitonin (salmon)................................................................ 1906Calcitriol .................................................................................. 1909Calcium (2.4.3.)......................................................................... 132Calcium acetate....................................................................... 1910Calcium ascorbate .................................................................. 1911Calcium carbonate.................................................................. 1912Calcium carboxymethylcellulose ................................... 9.4-5335Calcium chloride dihydrate................................................... 1912Calcium chloride hexahydrate .............................................. 1913Calcium dobesilate monohydrate ......................................... 1914Calcium edetate, sodium ....................................................... 3568Calcium fluoratum for homoeopathic preparations ... 9.5-5624Calcium folinate hydrate................................................. 9.7-6579Calcium glucoheptonate ........................................................ 1917Calcium gluconate .................................................................. 1917Calcium gluconate, anhydrous.............................................. 1918Calcium gluconate for injection ........................................... 1919Calcium glycerophosphate .................................................... 1920Calcium hydrogen phosphate ........................................ 9.6-6050Calcium hydrogen phosphate dihydrate.............................. 1922Calcium hydroxide ................................................................. 1923



Calcium in adsorbed vaccines (2.5.14.) ................................. 166Calcium iodatum for homoeopathic preparations ............. 1596Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1596

Calcium lactate........................................................................ 1923Calcium lactate monohydrate ............................................... 1924Calcium lactate pentahydrate................................................ 1924Calcium lactate trihydrate ..................................................... 1925Calcium levofolinate hydrate ......................................... 9.7-6581Calcium levulinate dihydrate ................................................ 1928Calcium pantothenate ............................................................ 1929Calcium pentetate (sodium) for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Calcium phosphate ................................................................. 1929Calcium stearate ..................................................................... 1930Calcium sulfate dihydrate...................................................... 1932Calendula flower..................................................................... 1297Calf coronavirus diarrhoea vaccine (inactivated)............... 1025Calf rotavirus diarrhoea vaccine (inactivated).................... 1026Calicivirosis vaccine (inactivated), feline ............................ 1053Calicivirosis vaccine (live), feline ......................................... 1054Camphor, D-............................................................................ 1932Camphor, racemic .................................................................. 1934Candesartan cilexetil .............................................................. 1935Canine adenovirus vaccine (inactivated)............................. 1027Canine adenovirus vaccine (live).......................................... 1028Canine distemper vaccine (live) ........................................... 1029Canine leptospirosis vaccine (inactivated) .......................... 1030Canine parainfluenza virus vaccine (live) ........................... 1032Canine parvovirosis vaccine (inactivated)........................... 1033Canine parvovirosis vaccine (live)........................................ 1034Cape aloes................................................................................ 1237Capecitabine............................................................................ 1937Cape jasmine fruit .................................................................. 1299Capillary electrophoresis (2.2.47.) ............................................ 81Capillary viscometer method (2.2.9.)............................ 9.6-5819Caprylate, sodium................................................................... 3569Caprylic acid ........................................................................... 1938Caprylocaproyl macrogolglycerides .............................. 9.1-4141Capsicum ................................................................................. 1300Capsicum oleoresin, refined and standardised ................... 1302Capsicum soft extract, standardised .................................... 1303Capsicum tincture, standardised .......................................... 1304Capsules ............................................................................ 9.4-5287Capsules and tablets, disintegration of (2.9.1.) ..................... 299Capsules, gastro-resistant ............................................... 9.4-5288Capsules, hard .................................................................. 9.4-5287Capsules, intrauterine .............................................................. 862Capsules, modified-release ............................................. 9.4-5288Capsules, oromucosal...................................................... 9.3-4789Capsules, rectal ......................................................................... 882Capsules, soft.................................................................... 9.4-5287Capsules, vaginal....................................................................... 888Captopril .................................................................................. 1940Caraway fruit........................................................................... 1305Caraway oil .............................................................................. 1306Carbachol................................................................................. 1942Carbamazepine ....................................................................... 1943Carbasalate calcium................................................................ 1945Carbidopa ......................................................................... 9.4-5333Carbimazole ............................................................................ 1948Carbocisteine........................................................................... 1949Carbomers ............................................................................... 1950Carbon dioxide ....................................................................... 1951Carbon dioxide in gases (2.5.24.) ........................................... 168Carbon monoxide................................................................... 1953Carbon monoxide (15O) ......................................................... 1130Carbon monoxide in gases (2.5.25.)....................................... 169Carbon monoxide intermix (5 per cent) in nitrogen .. 9.3-4865Carboplatin.............................................................................. 1954Carboprost trometamol ......................................................... 1955Carboxymethylcellulose......................................................... 1957Carboxymethylcellulose calcium ................................... 9.4-5335

Carboxymethylcellulose sodium........................................... 1958Carboxymethylcellulose sodium, cross-linked ................... 2174Carboxymethylcellulose sodium, low-substituted.............. 1958Carisoprodol............................................................................ 1956Carmellose............................................................................... 1957Carmellose calcium ......................................................... 9.4-5335Carmellose sodium................................................................. 1958Carmellose sodium and microcrystalline cellulose............ 3068Carmellose sodium, low-substituted.................................... 1958Carmustine .............................................................................. 1960Carnauba wax.......................................................................... 1960Carprofen for veterinary use ................................................. 1961Carrageenan ............................................................................ 1962Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use (5.2.11.) ............... 626

Carteolol hydrochloride......................................................... 1963Carvedilol ................................................................................ 1965Cascara..................................................................................... 1307Cascara dry extract, standardised......................................... 1308Cassia oil .................................................................................. 1310Castor oil, hydrogenated........................................................ 1966Castor oil, polyoxyl................................................................. 2950Castor oil, polyoxyl hydrogenated........................................ 2949Castor oil, refined ............................................................ 9.7-6583Castor oil, virgin ..................................................................... 1968Catgut, sterile .......................................................................... 1207Catgut, sterile, in distributor for veterinary use ................. 1219CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 269

Cefaclor.................................................................................... 1969Cefadroxil monohydrate........................................................ 1970Cefalexin monohydrate.......................................................... 1972Cefalotin sodium .................................................................... 1973Cefamandole nafate................................................................ 1974Cefapirin sodium.................................................................... 1976Cefatrizine propylene glycol.................................................. 1977Cefazolin sodium............................................................. 9.7-6584Cefepime dihydrochloride monohydrate ..................... 9.2-4513Cefixime............................................................................ 9.4-5335Cefoperazone sodium ............................................................ 1984Cefotaxime sodium ................................................................ 1985Cefoxitin sodium .................................................................... 1987Cefpodoxime proxetil ............................................................ 1989Cefprozil monohydrate ................................................... 9.4-5337Cefradine ................................................................................. 1994Ceftazidime pentahydrate............................................... 9.3-4865Ceftazidime pentahydrate with sodium carbonate forinjection .......................................................................... 9.3-4867

Ceftriaxone sodium................................................................ 2000Cefuroxime axetil ............................................................ 9.2-4515Cefuroxime sodium................................................................ 2003Celandine, greater................................................................... 1380Celecoxib ................................................................................. 2004Celiprolol hydrochloride ....................................................... 2005Cell-based and gene therapy medicinal products, raw materialsof biological origin for the production of (5.2.12.) ............ 627

Cell-based preparations, microbiological examination of(2.6.27.) ........................................................................... 9.2-4297

Cell count and viability, nucleated (2.7.29.).......................... 275Cell cultures for the production of veterinary vaccines(5.2.4.) ...................................................................................... 606

Cell substrates for the production of vaccines for human use(5.2.3.) ............................................................................. 9.3-4733

Cellulose acetate .............................................................. 9.7-6587Cellulose acetate butyrate ...................................................... 2008Cellulose acetate phthalate .................................................... 2009Cellulose, microcrystalline ............................................. 9.6-6052Cellulose (microcrystalline) and carmellose sodium......... 3068Cellulose, powdered ............................................................... 2013Centaury .................................................................................. 1310Centella .................................................................................... 1311Cetirizine dihydrochloride .................................................... 2017Cetostearyl alcohol ................................................................. 2019



Cetostearyl alcohol (type A), emulsifying ........................... 2019Cetostearyl alcohol (type B), emulsifying ........................... 2021Cetostearyl isononanoate ...................................................... 2022Cetostearyl sulfate, sodium ............................................ 9.4-5443Cetrimide................................................................................. 2022Cetyl alcohol............................................................................ 2023Cetyl palmitate ........................................................................ 2024Cetylpyridinium chloride ...................................................... 2025Ceylon cinnamon bark oil ..................................................... 1318Ceylon cinnamon leaf oil....................................................... 1318CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 274

Chamomile flower, Roman ................................................... 1313Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) .......... 9.7-6323

Characterisation of crystalline solids by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109

Characterisation of preparations for nebulisation (2.9.44.).. 378Characters section in monographs (5.11.) ............................ 729Charcoal, activated ................................................................. 2025Chemical imaging (5.24.) ............................................... 9.6-5897Chemical precursors for radiopharmaceuticalpreparations ............................................................................ 813

Chemometric methods applied to analytical data (5.21.) ... 783Chenodeoxycholic acid ......................................................... 2026Chewable tablets .............................................................. 9.3-4792Chewing gums, medicated ............................................. 9.3-4784Chewing gums, medicated, dissolution test for (2.9.25.)..... 340Chicken anaemia vaccine (live), infectious .................. 9.5-5598Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.) ........... 599

Chinese goldthread rhizome .......................................... 9.1-4102Chitosan hydrochloride ......................................................... 2028Chlamydiosis vaccine (inactivated), feline ......................... 1055Chloral hydrate ....................................................................... 2029Chlorambucil .......................................................................... 2029Chloramine.............................................................................. 3816Chloramphenicol ............................................................. 9.7-6588Chloramphenicol palmitate................................................... 2032Chloramphenicol sodium succinate..................................... 2033Chlorcyclizine hydrochloride................................................ 2034Chlordiazepoxide.................................................................... 2035Chlordiazepoxide hydrochloride .......................................... 2036Chlorhexidine diacetate .................................................. 9.4-5339Chlorhexidine digluconate solution .............................. 9.3-4871Chlorhexidine dihydrochloride ..................................... 9.4-5341Chlorides (2.4.4.) ...................................................................... 132Chlormadinone acetate.......................................................... 2043Chlorobutanol .................................................................. 9.6-6055Chlorobutanol hemihydrate ........................................... 9.6-6056Chlorocresol ............................................................................ 2046Chloroquine phosphate ......................................................... 2047Chloroquine sulfate ................................................................ 2048Chlorphenamine maleate ...................................................... 2048Chlorpromazine hydrochloride ............................................ 2050Chlorprothixene hydrochloride............................................ 2052Chlortalidone .......................................................................... 2054Chlortetracycline hydrochloride........................................... 2055Cholecalciferol ........................................................................ 2058Cholecalciferol concentrate (oily form)........................ 9.6-6057Cholecalciferol concentrate (powder form) ........................ 2061Cholecalciferol concentrate (water-dispersible form)........ 2062Cholera vaccine (inactivated), fowl ...................................... 1063Cholera vaccine (inactivated, oral)......................................... 898Cholesterol............................................................................... 2064Cholesterol for parenteral use ........................................ 9.2-4517Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 157Choline ([11C]methyl) injection..................................... 9.7-6531Chondroitin sulfate sodium .................................................. 2067Chromatographic separation techniques (2.2.46.) ...... 9.2-4286Chromatography, gas (2.2.28.)....................................... 9.6-5821Chromatography, liquid (2.2.29.) .................................. 9.6-5822Chromatography, paper (2.2.26.) ............................................. 42

Chromatography, size-exclusion (2.2.30.) .................... 9.6-5823Chromatography, supercritical fluid (2.2.45.)......................... 74Chromatography, thin-layer (2.2.27.) ...................................... 43Chromium (51Cr) edetate injection ...................................... 1131Chymotrypsin ......................................................................... 2069Ciclesonide .............................................................................. 2070Ciclopirox ................................................................................ 2071Ciclopirox olamine ................................................................. 2072Ciclosporin .............................................................................. 2074Cilastatin sodium.................................................................... 2075Cilazapril.................................................................................. 2077Cimetidine ........................................................................ 9.4-5343Cimetidine hydrochloride .............................................. 9.4-5345Cinchocaine hydrochloride ............................................ 9.6-6059Cinchona bark......................................................................... 1314Cinchona liquid extract, standardised ................................. 1316Cineole ..................................................................................... 2083Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 285Cineole type niaouli oil.......................................................... 1453Cinnamon................................................................................ 1317Cinnamon bark oil, Ceylon................................................... 1318Cinnamon leaf oil, Ceylon..................................................... 1318Cinnarizine.............................................................................. 2084Ciprofibrate ............................................................................. 2085Ciprofloxacin........................................................................... 2086Ciprofloxacin hydrochloride ................................................. 2088Circular dichroism (2.2.41.) ...................................................... 69Cisatracurium besilate .................................................... 9.4-5347Cisplatin................................................................................... 2094Citalopram hydrobromide.............................................. 9.3-4876Citalopram hydrochloride .............................................. 9.3-4877Citric acid ................................................................................ 2098Citric acid monohydrate ........................................................ 2099Citronella oil............................................................................ 1319Cladribine ................................................................................ 2100Clarithromycin................................................................. 9.4-5351Clarity and degree of opalescence of liquids (2.2.1.)... 9.2-4285Clary sage oil ........................................................................... 1320Classical swine-fever vaccine (live, prepared in cellcultures) ................................................................................. 1104

Clazuril for veterinary use..................................................... 2104Clebopride malate .................................................................. 2106Clemastine fumarate ....................................................... 9.3-4879Clematis armandii stem.................................................. 9.3-4813Clenbuterol hydrochloride .................................................... 2109Clindamycin hydrochloride ........................................... 9.3-4880Clindamycin phosphate ......................................................... 2111Clioquinol................................................................................ 2114Clobazam................................................................................. 2115Clobetasol propionate ............................................................ 2116Clobetasone butyrate.............................................................. 2118Clodronate disodium tetrahydrate ....................................... 2119Clofazimine ............................................................................. 2120Clofibrate ................................................................................. 2122Clomifene citrate ............................................................. 9.5-5635Clomipramine hydrochloride ............................................... 2124Clonazepam............................................................................. 2126Clonidine hydrochloride........................................................ 2127Clopamide ............................................................................... 2128Clopidogrel besilate ................................................................ 2129Clopidogrel hydrochloride .................................................... 2131Clopidogrel hydrogen sulfate ................................................ 2133Clorazepate, dipotassium monohydrate ....................... 9.7-6597Closantel sodium dihydrate for veterinary use............ 9.7-6589Clostridium botulinum vaccine for veterinary use ............ 1035Clostridium chauvoei vaccine for veterinary use ............... 1036Clostridium novyi (type B) vaccine for veterinary use...... 1036Clostridium perfringens vaccine for veterinary use........... 1038Clostridium septicum vaccine for veterinary use............... 1040Closures and containers for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.4-5123



Closures and containers for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428

Closures and tubing, silicone elastomer for (3.1.9.) ............. 409Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ............................................................................. 9.5-5545

Clotrimazole............................................................................ 2136Clove......................................................................................... 1322Clove oil ................................................................................... 1323Cloxacillin sodium ................................................................. 2137Clozapine ................................................................................. 2139Coagulation factor II, human, assay of (2.7.18.)................... 266Coagulation factor IX, human .............................................. 2674Coagulation factor IX, human, assay of (2.7.11.) ................. 259Coagulation factor IX (rDNA) concentrated solution,human ............................................................................. 9.3-4915

Coagulation factor IX (rDNA) powder for solution forinjection, human............................................................ 9.3-4920

Coagulation factors, activated (2.6.22.) ................................. 219Coagulation factors, assay of heparin (2.7.12.) ..................... 259Coagulation factor VIIa (rDNA) concentrated solution,human ............................................................................. 9.5-5687

Coagulation factor VII, human ............................................ 2666Coagulation factor VII, human, assay of (2.7.10.)................ 258Coagulation factor VIII, human........................................... 2672Coagulation factor VIII, human, assay of (2.7.4.) ................ 246Coagulation factor VIII (rDNA), human ............................ 2673Coagulation factor X, assay of (2.7.19.) ................................. 266Coagulation factor XI, human .............................................. 2681Coagulation factor XI, human, assay of (2.7.22.) ................. 269Coated granules ............................................................... 9.6-5913Coated tablets................................................................... 9.3-4791Cocaine hydrochloride........................................................... 2140Coccidiosis vaccine (live) for chickens ................................ 1042Cocculus for homoeopathic preparations ........................... 1597Coconut oil, refined................................................................ 2141Cocoyl caprylocaprate............................................................ 2142Codeine hydrochloride dihydrate.................................. 9.5-5636Codeine monohydrate..................................................... 9.5-5639Codeine phosphate hemihydrate ................................... 9.5-5641Codeine phosphate sesquihydrate ........................................ 2148Codergocrine mesilate ........................................................... 2149Cod-liver oil, farmed.............................................................. 2151Cod-liver oil (type A)............................................................. 2155Cod-liver oil (type B) ............................................................. 2159Codonopsis root ..............................................................9.3-4815Coix seed........................................................................... 9.2-4457Cola .......................................................................................... 1326Colchicine.........................................................................9.4-5354Cold-water vibriosis vaccine (inactivated) forsalmonids........................................................................ 9.2-4428

Colestyramine ......................................................................... 2164Colibacillosis vaccine (inactivated), neonatal piglet .......... 1077Colibacillosis vaccine (inactivated), neonatal ruminant.... 1079Colistimethate sodium.................................................... 9.4-5356Colistin sulfate ................................................................. 9.6-6060Colloidal anhydrous silica ..................................................... 3549Colloidal hydrated silica ........................................................ 3550Colloidal silica, hydrophobic ................................................ 3551Colloidal silver, for external use ........................................... 3552Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 274

Colophony ............................................................................... 1327Coloration of liquids (2.2.2.) ..................................................... 22Common selfheal fruit-spike ................................................ 1327Common stinging nettle for homoeopathic preparations.. 1614Comparative table of porosity of sintered-glass filters(2.1.2.) ........................................................................................ 15

Complexometric titrations (2.5.11.) ....................................... 164Composition of fatty acids by gas chromatography(2.4.22.) .................................................................................... 141

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) ........................................................................... 9.7-6293

Compressed lozenges ...................................................... 9.3-4789Concentrated solutions for haemodialysis ................... 9.6-6115Concentrated solutions for haemofiltration andhaemodiafiltration .........................................................9.6-6117

Concentrates for injections or infusions................................ 872Concentrates for intrauterine solutions ................................. 862Conductivity (2.2.38.) ..................................................... 9.6-5824Coneflower herb, purple ........................................................ 1486Coneflower root, narrow-leaved ........................................... 1447Coneflower root, pale............................................................. 1467Coneflower root, purple......................................................... 1488Conjugated estrogens ............................................................. 2410Conjugated polysaccharide vaccines for human use, carrierproteins for the production of (5.2.11.) ............................... 626

Consistency by penetrometry, measurement of (2.9.9.) ...... 313Containers (3.2.) ....................................................................... 423Containers and closures for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.4-5123

Containers and closures for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ................................................................................... 429

Containers for aqueous solutions for intravenous infusion,materials based on, plasticised poly(vinyl chloride) for(3.1.14.) ........................................................................... 9.6-5852

Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) .......................................................................... 9.6-5843

Containers for human blood and blood components, materialsfor (3.1.1.) ................................................................................ 391

Containers for human blood and blood components, plastic,sterile (3.2.3.).................................................................. 9.6-5865

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) .................................................................................... 410

Containers for parenteral preparations and forophthalmic preparations, polyethylene with additives for(3.1.5.) ............................................................................. 9.4-5120

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.) ............................................................................. 9.2-4310

Containers for pharmaceutical use, glass (3.2.1.) ........ 9.6-5859Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) ................................ 419

Containers for solid dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.) .................................................................................... 412

Containers, materials used for the manufacture of (3.1.).... 391Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.)............ 9.6-5866

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) ..... 9.6-5868

Contamination, microbial : microbial enumeration tests(2.6.12.) .................................................................................... 195

Contamination, microbial: microbial enumeration tests (livebiotherapeutic products) (2.6.36.) ............................... 9.7-6297

Contamination, microbial : test for specified micro-organisms(2.6.13.) .................................................................................... 199

Contamination, microbial: tests for specified micro-organisms(live biotherapeutic products) (2.6.38.) ...................... 9.7-6301

Content uniformity of single-dose preparations (2.9.6.) ..... 312Control of impurities in substances for pharmaceutical use(5.10.) ....................................................................................... 723

Control of microbiological quality, alternative methods for(5.1.6.) ............................................................................. 9.2-4339

Copolymer, basic butylated methacrylate .................... 9.4-5325Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 2945Copolymer, methacrylic acid - ethyl acrylate (1:1) ..... 9.6-6159



Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ............................................................................. 3017

Copolymer, methacrylic acid – methyl methacrylate(1:1) ........................................................................................ 3018

Copolymer, methacrylic acid - methyl methacrylate(1:2) ........................................................................................ 3019

Copolymer (type A), ammonio methacrylate.............. 9.6-6014Copolymer (type B), ammonio methacrylate .............. 9.6-6015Copovidone ...................................................................... 9.3-4882Copper acetate monohydrate for homoeopathicpreparations .......................................................................... 1599

Copper for homoeopathic preparations .............................. 1600Copper sulfate ......................................................................... 2169Copper sulfate pentahydrate ................................................. 2170Copper tetramibi tetrafluoroborate for radiopharmaceuticalpreparations ................................................................... 9.2-4435

Coriander................................................................................. 1329Coriander oil ........................................................................... 1330Coronavirus diarrhoea vaccine (inactivated), calf ............. 1025Cortisone acetate .................................................................... 2170Corydalis rhizome ........................................................... 9.7-6545Cotton, absorbent ................................................................... 2172Cottonseed oil, hydrogenated .............................................. 2173Couch grass rhizome.............................................................. 1331Creams ....................................................................................... 883Cresol, crude ........................................................................... 2173Crocus for homoeopathic preparations ............................... 1599Cromoglicate, sodium............................................................ 3574Croscarmellose sodium ......................................................... 2174Crospovidone ................................................................... 9.7-6591Crotamiton .............................................................................. 2177Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.)...... 9.7-6323

Crystalline solids, characterisation by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109

Crystallinity (5.16.)................................................................... 757Cuprum aceticum for homoeopathic preparations............ 1599Cuprum metallicum for homoeopathic preparations........ 1600Cutaneous application, liquid preparations for .................... 864Cutaneous application, powders for....................................... 874Cutaneous application, semi-solid preparations for ............ 882Cutaneous application, veterinary liquid preparationsfor .................................................................................... 9.3-4792

Cutaneous foams ...................................................................... 864Cutaneous patches .................................................................... 882Cyanocobalamin ..................................................................... 2178Cyanocobalamin (57Co) capsules .......................................... 1132Cyanocobalamin (57Co) solution .......................................... 1133Cyanocobalamin (58Co) capsules .......................................... 1134Cyanocobalamin (58Co) solution .......................................... 1134Cyclamate, sodium ................................................................. 3576Cyclizine hydrochloride......................................................... 2179Cyclopentolate hydrochloride ............................................... 2180Cyclophosphamide ................................................................. 2181Cyproheptadine hydrochloride............................................. 2182Cyproterone acetate................................................................ 2183Cysteine hydrochloride monohydrate.................................. 2185Cystine .............................................................................. 9.6-6062Cytarabine ........................................................................ 9.6-6063

DDacarbazine............................................................................. 2193Dalteparin sodium.................................................................. 2194Danaparoid sodium................................................................ 2196Dandelion herb with root ...................................................... 1332Dandelion root........................................................................ 1333Dapsone ................................................................................... 2198Daunorubicin hydrochloride ................................................ 2199D-Camphor.............................................................................. 1932Decyl oleate ............................................................................. 2200Deferiprone ...................................................................... 9.5-5647Deferiprone oral solution ............................................... 9.7-6595

Deferoxamine mesilate.................................................... 9.3-4887Degree of coloration of liquids (2.2.2.) .................................... 22Dembrexine hydrochloride monohydrate for veterinaryuse.................................................................................... 9.2-4526

Demeclocycline hydrochloride ............................................. 2203Demonstration of uniformity of dosage units using largesample sizes (2.9.47.).............................................................. 384

Density of powders, bulk density and tapped(2.9.34.) ........................................................................... 9.7-6328

Density of solids (2.2.42.) .......................................................... 70Density of solids, gas pycnometric (2.9.23.)................. 9.7-6319Density, relative (2.2.5.) ............................................................. 25Dental type silica .................................................................... 3550Depressor substances (2.6.11.) ................................................ 195Deptropine citrate................................................................... 2205Dequalinium chloride ............................................................ 2206Desacyl-4-monophosphoryl lipid A, 3-O- ......................... 2207Desflurane................................................................................ 2209Desipramine hydrochloride................................................... 2210Deslanoside ............................................................................. 2211Desloratadine .......................................................................... 2212Desmopressin .......................................................................... 2213Desogestrel .............................................................................. 2215Detection and measurement of radioactivity (2.2.66.) ........ 113Detection, direct amperometric and pulsed electrochemical(2.2.63.) ........................................................................... 9.7-6288

Detector tubes, gas (2.1.6.) ............................................. 9.3-4685Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 289Determination of bactericidal, fungicidal or yeasticidal activityof antiseptic medicinal products (5.1.11.) .................. 9.2-4348

Determination of elemental impurities (2.4.20.) ......... 9.6-5833Determination of nitrogen by sulfuric acid digestion(2.5.9.) ...................................................................................... 164

Determination of primary aromatic amino-nitrogen(2.5.8.) ...................................................................................... 163

Determination of water by distillation (2.2.13.) ..................... 31Detomidine hydrochloride for veterinary use .................... 2217Devil’s claw dry extract .......................................................... 1334Devil’s claw root ............................................................... 9.6-5988Dexamethasone....................................................................... 2218Dexamethasone acetate.......................................................... 2220Dexamethasone isonicotinate ............................................... 2222Dexamethasone sodium phosphate...................................... 2223Dexamfetamine sulfate ................................................... 9.7-6595Dexchlorpheniramine maleate.............................................. 2226Dexpanthenol.......................................................................... 2227Dextran 1 for injection.................................................... 9.4-5363Dextran 40 for injection ........................................................ 2229Dextran 60 for injection ........................................................ 2230Dextran 70 for injection ........................................................ 2231Dextranomer ........................................................................... 2231Dextrans, molecular mass distribution in (2.2.39.)................ 62Dextrin ..............................................................................9.6-6069Dextromethorphan hydrobromide....................................... 2233Dextromoramide tartrate ...................................................... 2234Dextropropoxyphene hydrochloride.................................... 2235Dextrose............................................................................ 9.1-4167Dextrose monohydrate.................................................... 9.1-4168Diacerein.................................................................................. 2236Diazepam................................................................................. 2238Diazoxide ................................................................................. 2240Dibrompropamidine diisetionate ......................................... 2240Dibutyl phthalate .................................................................... 2241Dichlorobenzyl alcohol, 2,4- ................................................. 2242Dichloromethane .................................................................... 3034Diclazuril for veterinary use.................................................. 2243Diclofenac potassium ............................................................. 2245Diclofenac sodium.................................................................. 2246Dicloxacillin sodium .............................................................. 2248Dicycloverine hydrochloride.......................................... 9.1-4147Didanosine .............................................................................. 2250Dienogest ................................................................................. 2252Diethylcarbamazine citrate.................................................... 2254



Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)................................................................. 157

Diethylene glycol monoethyl ether ...................................... 2256Diethylene glycol palmitostearate......................................... 2257Diethyl phthalate .................................................................... 2253Diethylstilbestrol..................................................................... 2258Diffraction, laser light, particle size analysis by(2.9.31.) .......................................................................... 9.7-6320

Difloxacin hydrochloride trihydrate for veterinary use..... 2259Digitalis for homoeopathic preparations...................... 9.6-6005Digitalis leaf............................................................................. 1336Digitoxin .................................................................................. 2260Digoxin .................................................................................... 2261Dihydralazine sulfate, hydrated ..................................... 9.2-4528Dihydrocodeine hydrogen tartrate ....................................... 2266Dihydroergocristine mesilate ................................................ 2267Dihydroergotamine mesilate................................................. 2269Dihydroergotamine tartrate .................................................. 2271Dihydrostreptomycin sulfate for veterinary use .......... 9.6-6070Dihydrotachysterol .......................................................... 9.6-6072Diltiazem hydrochloride........................................................ 2276Dimenhydrinate...................................................................... 2277Dimercaprol ............................................................................ 2279Dimethylacetamide ................................................................ 2280Dimethylaniline, N,N- (2.4.26.) .............................................. 152Dimethyl sulfoxide ................................................................. 2279Dimeticone .............................................................................. 2281Dimetindene maleate ............................................................. 2282Dinoprostone ................................................................... 9.2-4529Dinoprost trometamol ........................................................... 2283Dioscorea nipponica rhizome ........................................ 9.5-5613Dioscorea oppositifolia rhizome........................................... 1337Diosmin ................................................................................... 2286Dioxan and ethylene oxide (2.4.25.)....................................... 151Dip concentrates .............................................................. 9.3-4792Diphenhydramine hydrochloride ......................................... 2288Diphenoxylate hydrochloride................................................ 2289Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273

Diphtheria and tetanus vaccine (adsorbed) .......................... 899Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900

Diphtheria antitoxin............................................................... 1115Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903

Diphtheria, tetanus and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905

Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ... 9.6-5920

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ... 9.5-5585

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ........................................................ 9.5-5587

Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Diphtheria, tetanus, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ...................................................................... 9.5-5590

Diphtheria vaccine (adsorbed)................................................ 924Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 247Diphtheria vaccine (adsorbed, reduced antigen content) ... 925Dipivefrine hydrochloride ..................................................... 2290Dipotassium clorazepate monohydrate ........................ 9.7-6597Dipotassium phosphate ......................................................... 2292Diprophylline .......................................................................... 2293Dipyridamole .......................................................................... 2294Direct amperometric and pulsed electrochemical detection(2.2.63.) ........................................................................... 9.7-6288

Dirithromycin ......................................................................... 2296Disintegration of suppositories and pessaries (2.9.2.) ......... 301Disintegration of tablets and capsules (2.9.1.) ...................... 299Disodium clodronate tetrahydrate ....................................... 2119Disodium edetate.................................................................... 2297Disodium etidronate .............................................................. 2433Disodium pamidronate pentahydrate .................................. 3259Disodium phosphate .............................................................. 2298Disodium phosphate dihydrate............................................. 2299Disodium phosphate dodecahydrate............................. 9.6-6073Disopyramide.......................................................................... 2300Disopyramide phosphate ....................................................... 2301Dispersible tablets............................................................ 9.3-4792Dissolution, apparent (2.9.43.)................................................ 377Dissolution, intrinsic (2.9.29.) ................................................ 347Dissolution test for lipophilic solid dosage forms (2.9.42.).. 377Dissolution test for solid dosage forms (2.9.3.) .................... 302Dissolution test for transdermal patches (2.9.4.).................. 309Dissolution testing, recommendations on (5.17.1.) ............. 761Distemper vaccine (live), canine........................................... 1029Distemper vaccine (live) for mustelids ................................ 1045Distillation range (2.2.11.) ......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .................................................................................... 367

Disulfiram................................................................................ 2302Dithranol ................................................................................. 2303DL-Methionine ........................................................................ 3025DL-α-Tocopheryl hydrogen succinate................................... 3806Dobesilate monohydrate, calcium ........................................ 1914Dobutamine hydrochloride ................................................... 2304Docetaxel ................................................................................. 2305Docetaxel trihydrate ............................................................... 2307Docusate sodium .................................................................... 2309Dodecyl gallate........................................................................ 2309Dog rose................................................................................... 1338Domperidone .......................................................................... 2310Domperidone maleate............................................................ 2312Dopamine hydrochloride ...................................................... 2313Dopexamine dihydrochloride ............................................... 2315Dorzolamide hydrochloride .................................................. 2316Dosage forms (glossary) ................................................. 9.2-4423Dosage units, demonstration of uniformity using large samplesizes (2.9.47.) ........................................................................... 384

Dosage units, uniformity of (2.9.40.) ............................ 9.1-4055Dosulepin hydrochloride................................................ 9.7-6598DOTATOC (gallium (68Ga)) injection .......................... 9.6-5979Doxapram hydrochloride ...................................................... 2319Doxazosin mesilate................................................................. 2320Doxepin hydrochloride .......................................................... 2322Doxorubicin hydrochloride................................................... 2323Doxycycline hyclate ................................................................ 2324Doxycycline monohydrate..................................................... 2326Doxylamine hydrogen succinate........................................... 2328Droperidol ............................................................................... 2329Droppers (2.1.1.)......................................................................... 15Drop point (2.2.17.)......................................................... 9.6-5819Drops (nasal) and sprays (liquid nasal) ................................. 867Drops, oral ........................................................................ 9.3-4786Drospirenone .......................................................................... 2331Dry extracts ...................................................................... 9.7-6521Drynaria rhizome ............................................................ 9.2-4459Dry residue of extracts (2.8.16.).............................................. 289Duck plague vaccine (live)..................................................... 1046



Duck viral hepatitis type I vaccine (live) ............................. 1047Duloxetine hydrochloride...................................................... 2332Dutasteride .............................................................................. 2334Dwarf pine oil ......................................................................... 1340Dydrogesterone....................................................................... 2336

EEar drops and ear sprays.......................................................... 856Ear powders............................................................................... 856Ear preparations........................................................................ 855Ear preparations, semi-solid ................................................... 856Ear sprays and ear drops.......................................................... 856Ear tampons .............................................................................. 856Ear washes ................................................................................. 856Ebastine............................................................................. 9.6-6077Eclipta herb ...................................................................... 9.2-4461Econazole................................................................................. 2342Econazole nitrate .................................................................... 2343Edetate (chromium (51Cr)) injection.................................... 1131Edetate, disodium................................................................... 2297Edetate, sodium calcium........................................................ 3568Edetic acid ............................................................................... 2344Edotreotide (gallium (68Ga)) injection.......................... 9.6-5979Edrophonium chloride........................................................... 2345Effervescent granules ...................................................... 9.6-5913Effervescent powders ............................................................... 875Effervescent tablets.......................................................... 9.3-4791Efficacy of antimicrobial preservation (5.1.3.)...................... 577Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.) ...................................................................................... 612

Egg drop syndrome 76 vaccine (inactivated) ..................... 1048Egg phospholipids for injection..................................... 9.2-4533Elder flower ............................................................................. 1342Electrochemical detection, pulsed, and direct amperometricdetection (2.2.63.) .......................................................... 9.7-6288

Electrophoresis (2.2.31.) ............................................................ 48Electrophoresis, capillary (2.2.47.) ........................................... 81Elemental impurities (5.20.)........................................... 9.3-4759Elemental impurities, determination of (2.4.20.) ........ 9.6-5833Eleutherococcus...................................................................... 1344Emedastine difumarate .......................................................... 2346Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.)............ 9.6-5866

Emulsifying cetostearyl alcohol (type A)............................. 2019Emulsifying cetostearyl alcohol (type B) ............................. 2021Emulsions, solutions and suspensions, oral ................. 9.3-4786Enalaprilat dihydrate.............................................................. 2349Enalapril maleate .................................................................... 2348Encephalitis vaccine (inactivated), tick-borne............. 9.6-5968Encephalomyelitis vaccine (live), infectious, avian ............ 1013Endotoxins, bacterial (2.6.14.) ....................................... 9.3-4707Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .................................................................................... 593

Enilconazole for veterinary use ............................................ 2351Enoxaparin sodium ................................................................ 2352Enoxolone ................................................................................ 2354Enrofloxacin for veterinary use...................................... 9.2-4535Entacapone .............................................................................. 2357Entecavir monohydrate................................................... 9.7-6603Enumeration of microbial contaminants in live biotherapeuticproducts (2.6.36.)........................................................... 9.7-6297

Enzootic pneumonia vaccine (inactivated), porcine.......... 1086Ephedra herb ........................................................................... 1346Ephedrine ................................................................................ 2360Ephedrine hemihydrate ......................................................... 2361Ephedrine hydrochloride....................................................... 2362Ephedrine hydrochloride, racemic ....................................... 2363Epinastine hydrochloride....................................................... 2364Epinephrine ............................................................................. 1650Epinephrine tartrate ............................................................... 1652Epirubicin hydrochloride ...................................................... 2365Eplerenone............................................................................... 2367

Eptacog alfa (activated) concentrated solution............ 9.5-5687Equine herpesvirus vaccine (inactivated)............................ 1050Equine influenza vaccine (inactivated) ................................ 1051Equisetum stem ...................................................................... 1347Ergocalciferol ................................................................... 9.7-6604Ergoloid mesilates................................................................... 2149Ergometrine maleate .............................................................. 2370Ergotamine tartrate ................................................................ 2371Erysipelas vaccine (inactivated), swine................................ 1104Erythritol ................................................................................. 2373Erythromycin .......................................................................... 2374Erythromycin estolate ............................................................ 2378Erythromycin ethylsuccinate.......................................... 9.3-4893Erythromycin lactobionate ............................................. 9.2-4536Erythromycin stearate ............................................................ 2388Erythropoietin concentrated solution........................... 9.6-6078Escitalopram............................................................................ 2395Escitalopram oxalate .............................................................. 2397Eserine salicylate..................................................................... 3335Esketamine hydrochloride.............................................. 9.3-4895Esomeprazole magnesium dihydrate ................................... 2401Esomeprazole magnesium trihydrate................................... 2402Esomeprazole sodium ..................................................... 9.7-6606Essential oils .............................................................................. 814Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 285Essential oils, fatty oils and resinified essential oils in(2.8.7.) ...................................................................................... 284

Essential oils, foreign esters in (2.8.6.) ................................... 284Essential oils in herbal drugs (2.8.12.) ................................... 285Essential oils, odour and taste (2.8.8.) ................................... 284Essential oils, residue on evaporation (2.8.9.)....................... 284Essential oils, solubility in alcohol (2.8.10.) .......................... 284Essential oils, water in (2.8.5.)................................................. 284Ester value (2.5.2.) .................................................................... 161Estradiol benzoate .................................................................. 2404Estradiol hemihydrate.....................................................9.1-4151Estradiol valerate .................................................................... 2407Estriol ................................................................................ 9.5-5651Estrogens, conjugated............................................................. 2410Etacrynic acid.......................................................................... 2413Etamsylate................................................................................ 2414Etanercept ......................................................................... 9.5-5652Ethacridine lactate monohydrate.......................................... 2415Ethambutol hydrochloride .................................................... 2416Ethanol (96 per cent).............................................................. 2417Ethanol, anhydrous................................................................. 2419Ethanol content (2.9.10.) ......................................................... 315Ether ......................................................................................... 2421Ether, anaesthetic.................................................................... 2422Ethinylestradiol ....................................................................... 2422Ethionamide ............................................................................ 2424Ethosuximide ................................................................... 9.6-6082Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ............................................................................... 157

Ethyl acetate ............................................................................ 2427Ethyl acrylate - methacrylic acid copolymer (1:1)....... 9.6-6159Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ............................................................................. 3017

Ethylcellulose.................................................................... 9.7-6608Ethylenediamine ..................................................................... 2431Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) .................................................................................... 157

Ethylene glycol monopalmitostearate .................................. 2430Ethylene glycol monostearate................................................ 2430Ethylene oxide and dioxan (2.4.25.) ....................................... 151Ethylhexanoic acid, 2- (2.4.28.)............................................... 154Ethylmorphine hydrochloride............................................... 2431Ethyl oleate .............................................................................. 2428Ethyl parahydroxybenzoate ................................................... 2428Ethyl parahydroxybenzoate sodium..................................... 3577Etidronate disodium............................................................... 2433Etilefrine hydrochloride......................................................... 2433Etodolac ................................................................................... 2435



Etofenamate............................................................................. 2437Etomidate................................................................................. 2439Etoposide ..........................................................................9.1-4152Eucalyptus leaf ........................................................................ 1349Eucalyptus oil .......................................................................... 1349Eucommia bark................................................................ 9.2-4462Eugenol .................................................................................... 2443European goldenrod............................................................... 1376European viper venom antiserum ........................................ 1119Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.) ...................................................................................... 612

Evaluation of safety of each batch of immunosera forveterinary use (5.2.9.)............................................................. 625

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...................................................................................... 610

Evening primrose oil, refined................................................ 2444Everolimus ........................................................................ 9.7-6610Evodia fruit....................................................................... 9.6-5990Excipients, functionality-related characteristics of(5.15.) .............................................................................. 9.2-4411

Exemestane.............................................................................. 2445Extemporaneous preparation of radiopharmaceuticals(5.19.) ....................................................................................... 767

Extractable volume of parenteral preparations, test for(2.9.17.) .................................................................................... 322

Extracts, dry ..................................................................... 9.7-6521Extracts, dry residue of (2.8.16.)............................................. 289Extracts, herbal drug ....................................................... 9.7-6519Extracts, herbal drug, monographs on (information chapter)(5.23.) .............................................................................. 9.7-6515

Extracts, liquid (fluid) ..................................................... 9.7-6520Extracts, loss on drying of (2.8.17.)........................................ 289Extracts, soft ..................................................................... 9.7-6521Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological examination (2.6.31.) ........... 232

Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological quality (5.1.8.) .............. 9.7-6474

Extracts, water for preparation of......................................... 3932Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ........................................................................... 9.4-5111

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.) ......................................... 222

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .................................................................................... 219

Eye drops ................................................................................... 857Eye lotions ................................................................................. 857Eye preparations ....................................................................... 857Eye preparations, semi-solid ................................................... 858

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) ............................................................. 580

Factor II, human coagulation, assay of (2.7.18.)................... 266Factor IX, human coagulation .............................................. 2674Factor IX, human coagulation, assay of (2.7.11.) ................. 259Factor IX (rDNA) concentrated solution, humancoagulation .....................................................................9.3-4915

Factor IX (rDNA) powder for solution for injection, humancoagulation ..................................................................... 9.3-4920

Factor VIIa (rDNA) concentrated solution, human coagulation......................................................................................... 9.5-5687

Factor VII, human coagulation............................................. 2666Factor VII, human coagulation, assay of (2.7.10.)................ 258Factor VIII, human coagulation ........................................... 2672Factor VIII, human coagulation, assay of (2.7.4.) ................ 246Factor VIII (rDNA), human coagulation ............................ 2673Factor X, human coagulation, assay of (2.7.19.) ................... 266Factor XI, human coagulation .............................................. 2681Factor XI, human coagulation, assay of (2.7.22.) ................. 269Falling ball and automatic rolling ball viscometer methods(2.2.49.) ........................................................................... 9.3-4690

Famotidine............................................................................... 2449

Fat, hard ................................................................................... 2639Fat, hard with additives.......................................................... 2640Fatty acids, composition by gas chromatography (2.4.22.).. 141Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) ........................................................................... 9.7-6293

Fatty oils, alkaline impurities in (2.4.19.) .............................. 138Fatty oils and resinified essential oils in essential oils(2.8.7.) ...................................................................................... 284

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .................................................................................... 141

Fatty oils, identification by thin-layer chromatography(2.3.2.) ............................................................................. 9.6-5829

Fatty oils, sterols in (2.4.23.).................................................... 144Fatty oils, vegetable................................................................... 848Fc function of immunoglobulin, test for (2.7.9.) ......... 9.3-4724Febantel for veterinary use .................................................... 2450Feeding stuffs for veterinary use, medicated, premixes for.. 875Felbinac .................................................................................... 2451Feline calicivirosis vaccine (inactivated).............................. 1053Feline calicivirosis vaccine (live)........................................... 1054Feline chlamydiosis vaccine (inactivated) ........................... 1055Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .......................................................................... 1056

Feline infectious enteritis (feline panleucopenia) vaccine(live) ....................................................................................... 1057

Feline leukaemia vaccine (inactivated) ................................ 1058Feline panleucopenia vaccine (inactivated)......................... 1056Feline panleucopenia vaccine (live) ..................................... 1057Feline viral rhinotracheitis vaccine (inactivated) ............... 1059Feline viral rhinotracheitis vaccine (live) ............................ 1060Felodipine ................................................................................ 2452Felypressin ............................................................................... 2454Fenbendazole for veterinary use........................................... 2455Fenbufen .................................................................................. 2456Fennel, bitter ........................................................................... 1352Fennel, sweet ........................................................................... 1353Fenofibrate............................................................................... 2457Fenoterol hydrobromide ........................................................ 2458Fentanyl............................................................................. 9.4-5373Fentanyl citrate................................................................. 9.4-5374Fenticonazole nitrate .............................................................. 2462Fenugreek .........................................................................9.6-5991Fermentation, products of .............................................. 9.6-5909Ferric chloride hexahydrate................................................... 2463Ferrous fumarate..................................................................... 2464Ferrous gluconate ................................................................... 2465Ferrous sulfate, dried.............................................................. 2466Ferrous sulfate heptahydrate ................................................. 2467Ferrum metallicum for homoeopathic preparations ......... 1601FET (18F) injection........................................................... 9.3-4797Feverfew................................................................................... 1355Fexofenadine hydrochloride.................................................. 2468Fibrinogen, human................................................................. 2682Fibrin sealant kit .............................................................. 9.7-6615Filgrastim concentrated solution................................... 9.3-4899Films, orodispersible ....................................................... 9.3-4790Finasteride ............................................................................... 2473Fineness, powder (2.9.35.) .............................................. 9.7-6331Fingolimod hydrochloride.............................................. 9.7-6616Fipronil for veterinary use.............................................. 9.5-5661Fish oil, rich in omega-3 acids .............................................. 2474Flavoxate hydrochloride......................................................... 2476Flecainide acetate.................................................................... 2478Fleeceflower root..................................................................... 1356Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.)............................................ 273

Flowability (2.9.16.) .................................................................. 321Flow cytometry (2.7.24.).......................................................... 271FLT (18F) injection .................................................................. 1127Flubendazole ........................................................................... 2479Flucloxacillin magnesium octahydrate ................................ 2480Flucloxacillin sodium............................................................. 2482Fluconazole.............................................................................. 2484



Flucytosine............................................................................... 2485Fludarabine phosphate........................................................... 2487Fludeoxyglucose (18F) injection ............................................ 1135Fludrocortisone acetate.......................................................... 2489Flumazenil ............................................................................... 2490Flumazenil (N-[11C]methyl) injection.................................. 1137Flumequine.............................................................................. 2492Flumetasone pivalate.............................................................. 2493Flunarizine dihydrochloride.................................................. 2494Flunitrazepam ......................................................................... 2495Flunixin meglumine for veterinary use ............................... 2496Fluocinolone acetonide.......................................................... 2497Fluocortolone pivalate............................................................ 2500Fluorescein .............................................................................. 2501Fluorescein sodium ................................................................ 2502Fluoride (18F) solution for radiolabelling............................. 1139Fluorides (2.4.5.) ....................................................................... 132Fluorimetry (2.2.21.) .................................................................. 36Fluorocholine (18F) injection.......................................... 9.7-6532Fluorodeoxythymidine (18F) injection ................................. 1127Fluorodopa (18F) (prepared by electrophilic substitution)injection ................................................................................. 1141

Fluorodopa (18F) (prepared by nucleophilic substitution)injection .......................................................................... 9.7-6534

Fluoroethyl-L-tyrosine (18F) injection ........................... 9.3-4797Fluoromisonidazole (18F) injection....................................... 1146Fluorouracil ...................................................................... 9.2-4545Fluoxetine hydrochloride....................................................... 2505Flupentixol dihydrochloride.................................................. 2507Fluphenazine decanoate......................................................... 2509Fluphenazine dihydrochloride .............................................. 2510Fluphenazine enantate ........................................................... 2512Flurazepam monohydrochloride .......................................... 2513Flurbiprofen............................................................................. 2514Fluspirilene .............................................................................. 2516Flutamide................................................................................. 2517Fluticasone propionate........................................................... 2518Flutrimazole ............................................................................ 2520Fluvastatin sodium ................................................................. 2521Fluvoxamine maleate.............................................................. 2523FMISO (18F) injection ............................................................ 1146Foams, cutaneous ..................................................................... 864Foams, intrauterine .................................................................. 862Foams, medicated ..................................................................... 859Foams, rectal ............................................................................. 882Foams, vaginal........................................................................... 889Folic acid hydrate............................................................. 9.5-5662Folinate hydrate, calcium................................................ 9.7-6579Follitropin......................................................................... 9.6-6087Follitropin concentrated solution .................................. 9.6-6092Foot-and-mouth disease (ruminants) vaccine(inactivated) ................................................................... 9.5-5597

Foreign esters in essential oils (2.8.6.).................................... 284Foreign matter (2.8.2.) ............................................................. 283Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .................................................................................... 141

Formaldehyde, free (2.4.18.).................................................... 137Formaldehyde solution (35 per cent) ................................... 2537Formic acid....................................................................... 9.4-5376Formoterol fumarate dihydrate............................................. 2537Foscarnet sodium hexahydrate ...................................... 9.2-4546Fosfomycin calcium................................................................ 2541Fosfomycin sodium ................................................................ 2542Fosfomycin trometamol......................................................... 2543Fosinopril sodium .................................................................. 2544Fourstamen stephania root.................................................... 1357Fowl cholera vaccine (inactivated) ....................................... 1063Fowl-pox vaccine (live) .......................................................... 1064Framycetin sulfate .................................................................. 2547Frangula bark .......................................................................... 1358Frangula bark dry extract, standardised.............................. 1359Frankincense, Indian.............................................................. 1392Fraxinus rhynchophylla bark ................................................ 1360

Free formaldehyde (2.4.18.)..................................................... 137Freezing point (2.2.18.) .............................................................. 34Fresh bilberry fruit dry extract, refined and standardised.. 9.7-6547

Friability of granules and spheroids (2.9.41.)........................ 375Friability of uncoated tablets (2.9.7.) ..................................... 312Fructose.................................................................................... 2548Fucus ........................................................................................ 1405Fulvestrant ............................................................................... 2549Fumitory ...........................................................................9.2-4465Functional groups and ions, identification reactions of(2.3.1.) ...................................................................................... 123

Functionality-related characteristics of excipients(5.15.) .............................................................................. 9.2-4411

Fungicidal, bactericidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Furosemide ....................................................................... 9.4-5377Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids.................................................................. 9.2-4427

Fusidate, sodium..................................................................... 3579Fusidic acid.............................................................................. 2552

GGabapentin ....................................................................... 9.4-5381Gadobutrol monohydrate ............................................... 9.3-4905Gadodiamide hydrate...................................................... 9.1-4165Galactose.................................................................................. 2562Galantamine hydrobromide ........................................... 9.6-6101Gallium (67Ga) citrate injection ............................................ 1148Gallium (68Ga) chloride solution for radiolabelling ........... 1148Gallium (68Ga) DOTATOC injection ............................ 9.6-5979Gallium (68Ga) edotreotide injection ............................ 9.6-5979Gammacyclodextrin ........................................................ 9.4-5382Gammadex ....................................................................... 9.4-5382Ganciclovir .............................................................................. 2566Gargles .............................................................................. 9.3-4788Garlic for homoeopathic preparations................................. 1590Garlic powder................................................................... 9.6-5992Gas adsorption, specific surface area by (2.9.26.)................. 344Gas chromatography (2.2.28.) ........................................ 9.6-5821Gas detector tubes (2.1.6.) .............................................. 9.3-4685Gases, carbon dioxide in (2.5.24.) .......................................... 168Gases, carbon monoxide in (2.5.25.)...................................... 169Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) .................................................................................... 170

Gases, nitrous oxide in (2.5.35.) ............................................. 176Gases, oxygen in (2.5.27.) ........................................................ 170Gases, water in (2.5.28.) ........................................................... 170Gas-gangrene antitoxin, mixed............................................. 1116Gas-gangrene antitoxin (novyi) ............................................ 1116Gas-gangrene antitoxin (perfringens).................................. 1117Gas-gangrene antitoxin (septicum)...................................... 1118Gas pycnometric density of solids (2.9.23.).................. 9.7-6319Gastrodia rhizome........................................................... 9.6-5993Gastro-resistant capsules ................................................ 9.4-5288Gastro-resistant granules ................................................ 9.6-5914Gastro-resistant tablets ................................................... 9.3-4791Gefitinib ............................................................................ 9.3-4906Gelatin............................................................................... 9.3-4907Gels ............................................................................................. 884Gels for injections..................................................................... 873Gemcitabine hydrochloride................................................... 2570Gemfibrozil....................................................................... 9.5-5679General notices (1.) ......................................................... 9.2-4275General texts on biological products (5.2.) ........................... 599General texts on microbiology (5.1.) ..................................... 575Genetically modified cells............................................... 9.7-6497Gene transfer medicinal products for human use(5.14.) ..............................................................................9.7-6497

Gentamicin sulfate.................................................................. 2573Gentian root ............................................................................ 1365Gentian tincture...................................................................... 1366



Gestodene ................................................................................ 2575Ginger ...................................................................................... 1367Gingival solutions ............................................................ 9.3-4788Ginkgo dry extract, refined and quantified......................... 1368Ginkgo leaf .............................................................................. 1370Ginseng .................................................................................... 1372Ginseng dry extract ................................................................ 1374Glass containers for pharmaceutical use (3.2.1.) ......... 9.6-5859Glibenclamide ......................................................................... 2577Gliclazide ................................................................................. 2578Glimepiride ............................................................................. 2580Glipizide............................................................................ 9.7-6621Glossary (dosage forms) ................................................. 9.2-4423Glucagon, human ................................................................... 2584Glucoheptonate, calcium ....................................................... 1917Glucosamine hydrochloride ........................................... 9.5-5680Glucosamine sulfate potassium chloride ...................... 9.5-5681Glucosamine sulfate sodium chloride........................... 9.5-5682Glucose.............................................................................. 9.1-4167Glucose, liquid ........................................................................ 2590Glucose, liquid, spray-dried .................................................. 2591Glucose monohydrate ..................................................... 9.1-4168Glutamic acid .......................................................................... 2593Glutathione.............................................................................. 2594Glycan analysis of glycoproteins (2.2.59.) ............................. 103Glycerol (85 per cent) ..................................................... 9.6-6104Glycerol ............................................................................. 9.6-6103Glycerol dibehenate................................................................ 2598Glycerol distearate .................................................................. 2599Glycerol formal ....................................................................... 2600Glycerol monocaprylate......................................................... 2601Glycerol monocaprylocaprate ............................................... 2602Glycerol monolinoleate.......................................................... 2603Glycerol mono-oleate ............................................................. 2604Glycerol monostearate 40-55 ......................................... 9.2-4551Glycerol triacetate................................................................... 3825Glyceryl trinitrate solution .................................................... 2606Glycine ..................................................................................... 2608Glycoproteins, glycan analysis of (2.2.59.) ............................ 103Glycopyrronium bromide...................................................... 2609Glycyrrhizate ammonium...................................................... 1716Goldenrod................................................................................ 1375Goldenrod, European............................................................. 1376Goldenseal rhizome................................................................ 1378Gonadorelin acetate......................................................... 9.4-5383Gonadotrophin, chorionic.............................................. 9.4-5385Gonadotrophin, equine serum, for veterinary use............. 2613Goserelin........................................................................... 9.6-6106Grafted copolymer, macrogol poly(vinyl alcohol) ............. 2945Gramicidin .............................................................................. 2616Granisetron hydrochloride............................................. 9.6-6108Granules............................................................................ 9.6-5913Granules and powders for oral solutions andsuspensions..................................................................... 9.3-4786

Granules and powders for syrups .................................. 9.3-4787Granules and spheroids, friability of (2.9.41.)....................... 375Granules, coated .............................................................. 9.6-5913Granules, effervescent ..................................................... 9.6-5913Granules, gastro-resistant ............................................... 9.6-5914Granules, modified-release............................................. 9.6-5913Greater celandine.................................................................... 1380Green tea........................................................................... 9.4-5304Griseofulvin...................................................................... 9.7-6623Guaiacol ................................................................................... 2620Guaifenesin....................................................................... 9.6-6110Guanethidine monosulfate .................................................... 2623Guar.......................................................................................... 1381Guarana............................................................................. 9.4-5306Guar galactomannan .............................................................. 2623Guidelines for using the test for bacterial endotoxins(5.1.10.) .................................................................................... 593

Guidelines for using the test for sterility (5.1.9.) .................. 592

HHaemagglutinins, anti-A and anti-B (2.6.20.)....................... 213Haematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.) ............................................................................... 269

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) .................................................................... 274

Haematopoietic stem cells, human................................ 9.7-6627Haemodiafiltration and haemofiltration, concentratedsolutions for.................................................................... 9.6-6117

Haemodiafiltration and haemofiltration, solutionsfor .................................................................................... 9.6-6119

Haemodialysis, concentrated solutions for .................. 9.6-6115Haemodialysis solutions, concentrated, water fordiluting................................................................................... 2627

Haemodialysis, solutions for .......................................... 9.6-6115Haemofiltration and haemodiafiltration, concentratedsolutions for.................................................................... 9.6-6117

Haemofiltration and haemodiafiltration, solutions for....... 9.6-6119

Haemophilus type b and meningococcal group C conjugatevaccine ..................................................................................... 926

Haemophilus type b (conjugate), diphtheria, tetanusand pertussis (acellular, component) vaccine(adsorbed) ...................................................................... 9.6-5920

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated)vaccine (adsorbed) ........................................................ 9.5-5587

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) ................................. 9.5-5585

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (whole cell) and poliomyelitis (inactivated) vaccine(adsorbed) ...................................................................... 9.5-5590

Haemophilus type b conjugate vaccine......................... 9.6-5922Haemorrhagic disease vaccine (inactivated), rabbit........... 1092Halofantrine hydrochloride................................................... 2633Haloperidol.............................................................................. 2634Haloperidol decanoate ........................................................... 2636Halothane ................................................................................ 2637Hamamelis bark ...................................................................... 1382Hamamelis leaf........................................................................ 1383Hard capsules ................................................................... 9.4-5287Hard fat .................................................................................... 2639Hard fat with additives........................................................... 2640Hard paraffin........................................................................... 3268Harmonisation, pharmacopoeial (5.8.)......................... 9.7-6477Hawthorn berries.................................................................... 1384Hawthorn leaf and flower ...................................................... 1385Hawthorn leaf and flower dry extract .................................. 1386Hawthorn leaf and flower liquid extract, quantified .......... 1387HCP assays (2.6.34.) ........................................................ 9.1-4041Healthy chicken flocks for the production of inactivatedvaccines for veterinary use (5.2.13.)..................................... 630

Heavy bismuth subnitrate...................................................... 1853Heavy kaolin............................................................................ 2847Heavy magnesium carbonate ................................................ 2955Heavy magnesium oxide........................................................ 2962Heavy metals (2.4.8.) ................................................................ 133Heavy metals in herbal drugs and herbal drug preparations(2.4.27.) .................................................................................... 152

Hedera helix for homoeopathic preparations ..................... 1602Helium ..................................................................................... 2642Heparin, assay of (2.7.5.) ................................................9.1-4049Heparin calcium .............................................................. 9.3-4911Heparin in coagulation factors, assay of (2.7.12.)................. 259Heparins, low-molecular-mass ............................................. 2646Heparin sodium............................................................... 9.3-4913Hepatitis A immunoglobulin, human.................................. 2683Hepatitis A (inactivated, adsorbed) and typhoid polysaccharidevaccine ............................................................................ 9.6-5924

Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed) ...................................................................... 9.6-5925



Hepatitis A vaccine, assay of (2.7.14.) ........................... 9.7-6314Hepatitis A vaccine (inactivated, adsorbed).................9.6-5926Hepatitis A vaccine (inactivated, virosome) ................ 9.6-5927Hepatitis B immunoglobulin for intravenous administration,human .................................................................................... 2684

Hepatitis B immunoglobulin, human .................................. 2684Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 901

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 910

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ........................... 9.5-5585

Hepatitis B vaccine (rDNA) ........................................... 9.6-5930Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 263Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : guidelines ....................................................... 214

Hepatitis type I vaccine (live), viral, duck ........................... 1047Heptaminol hydrochloride .................................................... 2649Herbal drug extracts........................................................ 9.7-6519Herbal drug extracts, monographs on (information chapter)(5.23.) .............................................................................. 9.7-6515

Herbal drug preparations ........................................................ 819Herbal drugs..................................................................... 9.2-4419Herbal drugs and herbal drug preparations, heavy metals in(2.4.27.) .................................................................................... 152

Herbal drugs and herbal drug preparations, high-performancethin-layer chromatography of (2.8.25.)................................ 295

Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 289Herbal drugs, essential oils in (2.8.12.).................................. 285Herbal drugs for homoeopathic preparations..................... 1570Herbal drugs, microscopic examination of (2.8.23)............. 295Herbal drugs : sampling and sample preparation (2.8.20.).. 291Herbal drugs, tannins in (2.8.14.)........................................... 288Herbal drugs, test for aristolochic acids in (2.8.21) ............. 292Herbal medicinal products for oral use and extracts used intheir preparation, microbiological examination (2.6.31.).. 232

Herbal medicinal products for oral use and extracts used intheir preparation, microbiological quality (5.1.8.) .... 9.7-6474

Herbal preparations.................................................................. 819Herbal substances ............................................................ 9.2-4419Herbal teas................................................................................. 820Herbal teas, instant................................................................... 820Herpesvirus vaccine (inactivated), equine........................... 1050Herpes zoster (shingles) vaccine (live).......................... 9.6-5963Hexamidine diisetionate ........................................................ 2650Hexetidine ............................................................................... 2651Hexosamines in polysaccharide vaccines (2.5.20.) ............... 167Hexylresorcinol ....................................................................... 2652High-molecular-mass macrogols.......................................... 2952High-performance thin-layer chromatography of herbal drugsand herbal drug preparations (2.8.25.) ................................ 295

Histamine (2.6.10.) ................................................................... 194Histamine dihydrochloride ................................................... 2653Histamine for homoeopathic preparations .................. 9.1-4118Histaminum for homoeopathic preparations .............. 9.1-4118Histidine .................................................................................. 2654Histidine hydrochloride monohydrate ................................ 2655Homatropine hydrobromide ................................................. 2657Homatropine methylbromide ............................................... 2658Homoeopathic pillules, coated.............................................. 1587Homoeopathic pillules, impregnated ............................ 9.1-4118Homoeopathic preparations........................................... 9.1-4117Homoeopathic preparations, acidum succinicum for.. 9.5-5621Homoeopathic preparations, Agaricus phalloidesfor .................................................................................... 9.5-5621

Homoeopathic preparations, Allium sativum for .............. 1590Homoeopathic preparations, ammonium carbonicumfor .................................................................................... 9.3-4827

Homoeopathic preparations, Anacardium for.................... 1591Homoeopathic preparations, Apis for.................................. 1592Homoeopathic preparations, arsenicum album for .... 9.5-5623

Homoeopathic preparations, aurum chloratum natronatumfor ................................................................................... 9.5-5623

Homoeopathic preparations, barium chloratum for.......... 1594Homoeopathic preparations, Belladonna for............... 9.2-4492Homoeopathic preparations, cadmium sulfuricum for..... 1596Homoeopathic preparations, calcium fluoratum for .. 9.5-5624Homoeopathic preparations, calcium iodatum for ............ 1596Homoeopathic preparations, Cocculus for ......................... 1597Homoeopathic preparations, Crocus for ............................. 1599Homoeopathic preparations, cuprum aceticum for........... 1599Homoeopathic preparations, cuprum metallicum for....... 1600Homoeopathic preparations, digitalis for .................... 9.6-6005Homoeopathic preparations, ferrum metallicum for ........ 1601Homoeopathic preparations, hedera helix for .................... 1602Homoeopathic preparations, herbal drugs for.................... 1570Homoeopathic preparations, hydrastis canadensis for ...... 1603Homoeopathic preparations, hyoscyamus for .................... 1604Homoeopathic preparations, hypericum for....................... 1605Homoeopathic preparations, kalium bichromicum for..... 1608Homoeopathic preparations, magnesium fluoratum for... 1609Homoeopathic preparations, magnesium phosphoricumfor ........................................................................................... 1609

Homoeopathic preparations, mother tinctures for ............ 1571Homoeopathic preparations, Nux-vomica for ............. 9.3-4829Homoeopathic preparations, petroleum rectificatum for.. 1612Homoeopathic preparations, pillules for ............................. 1586Homoeopathic preparations, selenium for................... 9.2-4494Homoeopathic preparations, Staphysagria for.................... 1612Homoeopathic preparations, sulfur for ............................... 1614Homoeopathic preparations, Urtica dioica for ................... 1614Homoeopathic stocks (methods of preparation of) andpotentisation .................................................................. 9.2-4479

Homoepathic preparations, Ignatia for......................... 9.3-4827Honey ....................................................................................... 2659Honey bee for homoeopathic preparations......................... 1592Hop strobile............................................................................. 1388Horse-chestnut........................................................................ 1389Horse-chestnut dry extract, standardised............................ 1390Host-cell protein assays (2.6.34.) ................................... 9.1-4041Houttuynia herb............................................................... 9.4-5307Human α-1-proteinase inhibitor .......................................... 2694Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 278Human albumin injection, iodinated (125I) ......................... 1152Human albumin solution ...................................................... 2660Human anti-D immunoglobulin .......................................... 2662Human anti-D immunoglobulin, assay of (2.7.13.) ............. 260Human anti-D immunoglobulin for intravenousadministration....................................................................... 2663

Human antithrombin III, assay of (2.7.17.)........................... 265Human antithrombin III concentrate .................................. 2664Human C1-esterase inhibitor................................................ 2665Human C1-esterase inhibitor, assay of (2.7.34.) ................... 278Human coagulation factor II, assay of (2.7.18.).................... 266Human coagulation factor IX ............................................... 2674Human coagulation factor IX, assay of (2.7.11.) .................. 259Human coagulation factor IX (rDNA) concentratedsolution ........................................................................... 9.3-4915

Human coagulation factor IX (rDNA) powder for solution forinjection .......................................................................... 9.3-4920

Human coagulation factor VII.............................................. 2666Human coagulation factor VIIa (rDNA) concentratedsolution ........................................................................... 9.5-5687

Human coagulation factor VII, assay of (2.7.10.)................. 258Human coagulation factor VIII ............................................ 2672Human coagulation factor VIII, assay of (2.7.4.) ................. 246Human coagulation factor VIII (rDNA) ............................. 2673Human coagulation factor X, assay of (2.7.19.) .................... 266Human coagulation factor XI ............................................... 2681Human coagulation factor XI, assay of (2.7.22.) .................. 269Human fibrinogen .................................................................. 2682Human glucagon..................................................................... 2584Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) .................................................................... 274



Human haematopoietic stem cells................................. 9.7-6627Human hepatitis A immunoglobulin................................... 2683Human hepatitis B immunoglobulin ................................... 2684Human hepatitis B immunoglobulin for intravenousadministration....................................................................... 2684

Human insulin ........................................................................ 2768Human measles immunoglobulin ........................................ 2685Human normal immunoglobulin for intramuscularadministration....................................................................... 2685

Human normal immunoglobulin for intravenousadministration....................................................................... 2687

Human normal immunoglobulin for subcutaneousadministration....................................................................... 2689

Human papillomavirus vaccine (rDNA) ......................9.6-5931Human plasma for fractionation .......................................... 2691Human plasma (pooled and treated for virusinactivation) ................................................................... 9.2-4555

Human plasmin inhibitor, assay of (2.7.25.) ......................... 272Human protein C, assay of (2.7.30.)....................................... 276Human protein S, assay of (2.7.31.)........................................ 277Human prothrombin complex .............................................. 2695Human rabies immunoglobulin ........................................... 2696Human rubella immunoglobulin ......................................... 2698Human tetanus immunoglobulin ......................................... 2698Human varicella immunoglobulin ....................................... 2700Human varicella immunoglobulin for intravenousadministration....................................................................... 2700

Human von Willebrand factor .............................................. 2701Human von Willebrand factor, assay of (2.7.21.) ................. 268Hyaluronate, sodium.............................................................. 3583Hyaluronidase ........................................................................ 2702Hydralazine hydrochloride............................................. 9.2-4557Hydrastis canadensis for homoeopathic preparations ....... 1603Hydrochloric acid, concentrated .......................................... 2704Hydrochloric acid, dilute ....................................................... 2704Hydrochlorothiazide .............................................................. 2705Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2706Hydrocortisone ....................................................................... 2708Hydrocortisone acetate .......................................................... 2711Hydrocortisone hydrogen succinate..................................... 2713Hydrogenated arachis oil ................................................ 9.6-6021Hydrogenated castor oil ......................................................... 1966Hydrogenated cottonseed oil................................................. 2173Hydrogenated soya-bean oil.................................................. 3630Hydrogenated vegetable oils, nickel in (2.4.31.) .......... 9.4-5103Hydrogenated wool fat........................................................... 3943Hydrogen peroxide solution (30 per cent) .......................... 2715Hydrogen peroxide solution (3 per cent) ............................ 2715Hydromorphone hydrochloride............................................ 2716Hydrophobic colloidal silica.................................................. 3551Hydrous wool fat .................................................................... 3944Hydroxocobalamin acetate .................................................... 2717Hydroxocobalamin chloride.................................................. 2718Hydroxocobalamin sulfate..................................................... 2719Hydroxycarbamide ................................................................. 2720Hydroxychloroquine sulfate ........................................... 9.3-4922Hydroxyethylcellulose ..................................................... 9.3-4924Hydroxyethylmethylcellulose ................................................ 3037Hydroxyethyl salicylate .......................................................... 2723Hydroxyethyl starches ..................................................... 9.6-6208Hydroxyl value (2.5.3.)............................................................. 161Hydroxypropylbetadex........................................................... 2725Hydroxypropylcellulose ......................................................... 2727Hydroxypropylcellulose, low-substituted ..................... 9.5-5691Hydroxypropylmethylcellulose ...................................... 9.6-6123Hydroxypropylmethylcellulose phthalate ............................ 2740Hydroxypropyl starch............................................................. 3645Hydroxypropyl starch, pregelatinised .................................. 3647Hydroxyzine hydrochloride............................................ 9.5-5693Hymecromone......................................................................... 2731Hymenoptera venoms for allergen products....................... 2732Hyoscine .................................................................................. 2733Hyoscine butylbromide................................................... 9.6-6121

Hyoscine hydrobromide ........................................................ 2735Hyoscyamine sulfate............................................................... 2737Hyoscyamus for homoeopathic preparations ..................... 1604Hypericum............................................................................... 1526Hypericum for homoeopathic preparations........................ 1605Hypromellose ................................................................... 9.6-6123Hypromellose phthalate ......................................................... 2740

IIbuprofen .......................................................................... 9.6-6129Iceland moss............................................................................ 1392ICH (5.8.).......................................................................... 9.7-6477Ichthammol ............................................................................. 2747Identification (2.3.) ................................................................... 123Identification and control of residual solvents (2.4.24.) ...... 146Identification of fatty oils by thin-layer chromatography(2.3.2.) ............................................................................. 9.6-5829

Identification of phenothiazines by thin-layer chromatography(2.3.3.) ...................................................................................... 127

Identification reactions of ions and functional groups(2.3.1.) ...................................................................................... 123

Idoxuridine .............................................................................. 2748Ifosfamide ................................................................................ 2749Ignatia for homoeopathic preparations ........................ 9.3-4827Imatinib mesilate ............................................................. 9.6-6131Imidacloprid for veterinary use ..................................... 9.6-6134Imipenem monohydrate ................................................. 9.4-5391Imipramine hydrochloride .................................................... 2754Immunochemical methods (2.7.1.) ........................................ 239Immunoglobulin for human use, anti-T lymphocyte,animal .................................................................................... 1741

Immunoglobulin for intramuscular administration, humannormal.................................................................................... 2685

Immunoglobulin for intravenous administration, humananti-D ..................................................................................... 2663

Immunoglobulin for intravenous administration, humanhepatitis B.............................................................................. 2684

Immunoglobulin for intravenous administration, humannormal.................................................................................... 2687

Immunoglobulin for intravenous administration, humanvaricella .................................................................................. 2700

Immunoglobulin for subcutaneous administration, humannormal.................................................................................... 2689

Immunoglobulin, human anti-D.......................................... 2662Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 260Immunoglobulin, human hepatitis A .................................. 2683Immunoglobulin, human hepatitis B................................... 2684Immunoglobulin, human measles ........................................ 2685Immunoglobulin, human rabies ........................................... 2696Immunoglobulin, human rubella ......................................... 2698Immunoglobulin, human tetanus......................................... 2698Immunoglobulin, human varicella....................................... 2700Immunoglobulin, test for anticomplementary activity of(2.6.17.) ........................................................................... 9.3-4713

Immunoglobulin, test for Fc function of (2.7.9.)......... 9.3-4724Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.)........................ 608

Immunonephelometry for vaccine component assay(2.7.35.) .................................................................................... 279

Immunosera and vaccines, phenol in (2.5.15.) ..................... 166Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610

Immunosera for human use, animal ............................. 9.6-5907Immunosera for veterinary use............................................... 823Immunosera for veterinary use, evaluation of the safety ofeach batch (5.2.9.)................................................................... 625

Implants ..................................................................................... 873Impurities, elemental, determination of (2.4.20.)........ 9.6-5833Impurities in substances for pharmaceutical use, control of(5.10.) ....................................................................................... 723



Inactivated vaccines for veterinary use, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630

Indapamide.............................................................................. 2755Indian frankincense................................................................ 1392Indicators, approximate pH of solutions (2.2.4.) .................... 25Indigo plant leaf ...................................................................... 1393Indinavir sulfate ...................................................................... 2757Indium (111In) chloride solution ........................................... 1153Indium (111In) oxine solution ................................................ 1154Indium (111In) pentetate injection ........................................ 1154Indometacin ..................................................................... 9.7-6631Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .................................................................................... 100

Inductively coupled plasma-mass spectrometry (2.2.58.) ... 101Infectious bovine rhinotracheitis vaccine (inactivated)..... 1067Infectious bovine rhinotracheitis vaccine (live).................. 1068Infectious bronchitis vaccine (inactivated), avian .............. 1007Infectious bronchitis vaccine (live), avian ........................... 1008Infectious bursal disease vaccine (inactivated), avian........ 1010Infectious bursal disease vaccine (live), avian..................... 1011Infectious chicken anaemia vaccine (live) .................... 9.5-5598Infectious encephalomyelitis vaccine (live), avian.............. 1013Infectious enteritis vaccine (inactivated), feline ................. 1056Infectious enteritis vaccine (live), feline .............................. 1057Infectious laryngotracheitis vaccine (live), avian ............... 1014Infectious rhinotracheitis vaccine (live), turkey ................. 1107Infliximab concentrated solution................................... 9.6-6135Influenza vaccine (inactivated), equine ............................... 1051Influenza vaccine (inactivated), porcine.............................. 1087Influenza vaccine (live, nasal) ................................................. 939Influenza vaccine (split virion, inactivated) ................. 9.6-5934Influenza vaccine (surface antigen, inactivated).......... 9.6-5936Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ................................................................... 9.6-5938

Influenza vaccine (surface antigen, inactivated,virosome)........................................................................ 9.6-5940

Influenza vaccine (whole virion, inactivated) .............. 9.6-5942Influenza vaccine (whole virion, inactivated, prepared in cellcultures) .......................................................................... 9.6-5943

Infrared absorption spectrophotometry (2.2.24.)........ 9.7-6285Infusions .................................................................................... 872Inhalation gas, krypton (81mKr)............................................. 1159Inhalation powders.......................................................... 9.4-5292Inhalation, preparations for ........................................... 9.4-5288Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323

Injectable insulin preparations.............................................. 2776Injections ................................................................................... 871Injections, gels for..................................................................... 873Injections or infusions, concentrates for ............................... 872Injections or infusions, powders for....................................... 872Inositol, myo- .......................................................................... 2761Inserts, ophthalmic................................................................... 858Instant herbal teas .................................................................... 820Insulin aspart........................................................................... 2762Insulin, bovine ................................................................. 9.3-4929Insulin glargine ................................................................ 9.5-5699Insulin, human........................................................................ 2768Insulin injection, biphasic ..................................................... 2770Insulin injection, biphasic isophane..................................... 2770Insulin injection, isophane .................................................... 2771Insulin injection, soluble ....................................................... 2771Insulin lispro ........................................................................... 2771Insulin, porcine ................................................................ 9.3-4931Insulin preparations, injectable............................................. 2776Insulin zinc injectable suspension ........................................ 2778Insulin zinc injectable suspension (amorphous) ................ 2779Insulin zinc injectable suspension (crystalline) .................. 2779Interferon alfa-2 concentrated solution ............................... 2780Interferon beta-1a concentrated solution ..................... 9.5-5701Interferon gamma-1b concentrated solution ...................... 2785Interferons, assay of (5.6.)........................................................ 689International System (SI) units (1.) ............................... 9.2-4275

Intramammary preparations for veterinary use ................... 861Intraruminal delivery systems ....................................... 9.3-4785Intrauterine capsules ................................................................ 862Intrauterine foams .................................................................... 862Intrauterine preparations for veterinary use ......................... 862Intrauterine solutions, suspensions ........................................ 862Intrauterine sticks ..................................................................... 862Intrauterine tablets ................................................................... 862Intrinsic dissolution (2.9.29.) .................................................. 347In vitro method(s) for the quality control of vaccines,substitution of in vivo method(s) by (5.2.14.)............ 9.3-4737

In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .................................................................................... 267

Iobenguane (123I) injection .................................................... 1155Iobenguane (131I) injection for diagnostic use..................... 1156Iobenguane (131I) injection for therapeutic use................... 1157Iobenguane sulfate for radiopharmaceutical preparations.. 9.2-4435

Iodinated (125I) human albumin injection ........................... 1152Iodinated povidone ................................................................ 3394Iodine ....................................................................................... 2788Iodine value (2.5.4.).................................................................. 161Iodixanol .................................................................................. 2788Iodohippurate (sodium) dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438

Iodomethylnorcholesterol (131I) injection............................ 1159Iohexol...................................................................................... 2791Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 60

Ions and functional groups, identification reactions of(2.3.1.) ...................................................................................... 123

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 60

Iopamidol................................................................................. 2795Iopanoic acid ........................................................................... 2797Iopromide ................................................................................ 2798Iotrolan .................................................................................... 2801Ioxaglic acid............................................................................. 2803Ipecacuanha liquid extract, standardised ............................ 1395Ipecacuanha, prepared ........................................................... 1395Ipecacuanha root .................................................................... 1397Ipecacuanha tincture, standardised...................................... 1398Ipratropium bromide ...................................................... 9.6-6141Irbesartan................................................................................. 2807Irinotecan hydrochloride trihydrate.............................. 9.3-4933Iron (2.4.9.)................................................................................ 136Iron for homoeopathic preparations.................................... 1601Irrigation, preparations for...................................................... 880Isatis root .......................................................................... 9.6-5995Isoconazole .............................................................................. 2810Isoconazole nitrate.................................................................. 2811Isoelectric focusing (2.2.54.) ..................................................... 89Isoflurane ................................................................................. 2813Isoleucine................................................................................. 2814Isomalt .............................................................................. 9.4-5392Isoniazid............................................................................ 9.5-5703Isophane insulin injection ..................................................... 2771Isoprenaline hydrochloride ................................................... 2817Isoprenaline sulfate................................................................. 2818Isopropyl alcohol .................................................................... 2819Isopropyl isostearate........................................................ 9.2-4563Isopropyl myristate................................................................. 2820Isopropyl palmitate................................................................. 2821Isosorbide dinitrate, diluted ................................................. 2821Isosorbide mononitrate, diluted .......................................... 2823Isotherms (sorption-desorption) and water activity,determination of (water-solid interactions) (2.9.39.)........ 9.7-6331

Isotretinoin ....................................................................... 9.5-5705Isoxsuprine hydrochloride..................................................... 2826Ispaghula husk ........................................................................ 1400Ispaghula seed ......................................................................... 1400Isradipine ................................................................................. 2828



Itraconazole ............................................................................. 2829Ivermectin................................................................................ 2832Ivy leaf ...................................................................................... 1401

JJavanese turmeric.................................................................... 1544Java tea ..................................................................................... 1402Josamycin................................................................................. 2837Josamycin propionate............................................................. 2839Juniper...................................................................................... 1404Juniper oil ................................................................................ 1404

KKalium bichromicum for homoeopathic preparations ...... 1608Kanamycin acid sulfate ................................................... 9.6-6145Kanamycin monosulfate ................................................. 9.6-6146Kaolin, heavy........................................................................... 2847Kelp........................................................................................... 1405Ketamine hydrochloride ........................................................ 2847Ketobemidone hydrochloride ............................................... 2848Ketoconazole ........................................................................... 2849Ketoprofen ............................................................................... 2851Ketorolac trometamol ............................................................ 2853Ketotifen hydrogen fumarate ................................................ 2854Knotgrass ................................................................................. 1406Krypton (81mKr) inhalation gas ............................................. 1159Kudzuvine root ................................................................ 9.7-6549Kudzuvine root, Thomson.............................................. 9.7-6555

LLabetalol hydrochloride.................................................. 9.4-5397Lacosamide....................................................................... 9.5-5709Lacosamide infusion ....................................................... 9.7-6635Lacosamide oral solution................................................ 9.7-6636Lactic acid................................................................................ 2860Lactic acid, (S)- ....................................................................... 2861Lactitol monohydrate ...................................................... 9.3-4939Lactobionic acid...................................................................... 2863Lactose .............................................................................. 9.3-4940Lactose monohydrate ...................................................... 9.3-4942Lactulose ........................................................................... 9.5-5710Lactulose, liquid............................................................... 9.5-5712Lamivudine.............................................................................. 2871Lamotrigine ............................................................................. 2873Lansoprazole .................................................................... 9.3-4945Largehead atractylodes rhizome.................................... 9.7-6544Laryngotracheitis vaccine (live), infectious, avian ............. 1014Laser light diffraction, particle size analysis by(2.9.31.) .......................................................................... 9.7-6320

Laurilsulfate, sodium....................................................... 9.1-4200Lauromacrogol 400................................................................. 2876Lauroyl macrogolglycerides............................................ 9.1-4173Lavender flower ............................................................... 9.5-5614Lavender oil ...................................................................... 9.5-5615Lavender oil, spike........................................................... 9.5-5617Lead in sugars (2.4.10.) ............................................................ 136Leflunomide ............................................................................ 2879Lemon oil................................................................................. 1411Lemon verbena leaf ................................................................ 1412Leptospirosis vaccine (inactivated), bovine......................... 1019Leptospirosis vaccine (inactivated), canine......................... 1030Letrozole .................................................................................. 2880Leucine..................................................................................... 2881Leukaemia vaccine (inactivated), feline............................... 1058Leuprorelin .............................................................................. 2883Levamisole for veterinary use ............................................... 2885Levamisole hydrochloride ..................................................... 2886Levetiracetam................................................................... 9.4-5399Levocabastine hydrochloride ......................................... 9.3-4946Levocarnitine.................................................................... 9.6-6149Levodopa ................................................................................. 2892Levodropropizine.................................................................... 2893

Levofolinate hydrate, calcium ........................................ 9.7-6581Levomenthol............................................................................ 2894Levomepromazine hydrochloride......................................... 2895Levomepromazine maleate.................................................... 2896Levomethadone hydrochloride ............................................. 2897Levonorgestrel......................................................................... 2899Levothyroxine sodium ........................................................... 2902Levulinate dihydrate, calcium ............................................... 1928Lidocaine ................................................................................. 2903Lidocaine hydrochloride monohydrate ........................ 9.6-6150Light liquid paraffin ........................................................ 9.5-5737Light magnesium carbonate .................................................. 2956Light magnesium oxide.......................................................... 2963Lightyellow sophora root................................................ 9.6-5996Ligusticum root and rhizome ........................................ 9.7-6550Lime flower.............................................................................. 1414Limit tests (2.4.) ........................................................................ 131Limit tests, standard solutions for (4.1.2.) .................... 9.7-6454Lincomycin hydrochloride .................................................... 2906Linen thread, sterile, in distributor for veterinary use ..... 1220Linoleoyl macrogolglycerides......................................... 9.1-4174Linseed ..................................................................................... 1415Linseed oil, virgin ................................................................... 2908Liothyronine sodium.............................................................. 2909Lipophilic solid dosage forms, dissolution test for(2.9.42.) .................................................................................... 377

Liquid chromatography (2.2.29.) ................................... 9.6-5822Liquid extraction preparations ...................................... 9.7-6520Liquid (fluid) extracts ..................................................... 9.7-6520Liquid glucose ......................................................................... 2590Liquid glucose, spray-dried ................................................... 2591Liquid lactulose................................................................ 9.5-5712Liquid maltitol ........................................................................ 2974Liquid paraffin ................................................................. 9.5-5737Liquid paraffin, light ....................................................... 9.5-5737Liquid preparations for cutaneous application ..................... 864Liquid preparations for cutaneous application,veterinary........................................................................ 9.3-4792

Liquid preparations for oral use .................................... 9.3-4785Liquids, clarity and degree of opalescence of (2.2.1.) .. 9.2-4285Liquid sorbitol (crystallising)................................................ 3626Liquid sorbitol (non-crystallising) ....................................... 3627Liquid sorbitol, partially dehydrated.................................... 3628Liquid sucrose .................................................................. 9.4-5448Liquorice dry extract for flavouring purposes .................... 1415Liquorice root ......................................................................... 1416Lisinopril dihydrate ................................................................ 2910Lithium carbonate .................................................................. 2912Lithium citrate ........................................................................ 2913Live biotherapeutic products for human use ............... 9.7-6522Live biotherapeutic products, microbiological examinationof (tests for enumeration of microbial contaminants)(2.6.36.) ........................................................................... 9.7-6297

Live biotherapeutic products, microbiological examination of(tests for specified micro-organisms) (2.6.38.) .......... 9.7-6301

L-Methionine ([11C]methyl) injection .................................. 1161Lobeline hydrochloride.......................................................... 2913Lomustine ................................................................................ 2914Long pepper ............................................................................ 1417Loosestrife ............................................................................... 1419Loperamide hydrochloride.................................................... 2915Loperamide oxide monohydrate........................................... 2917Lopinavir.................................................................................. 2918Loratadine................................................................................ 2922Lorazepam ............................................................................... 2924Losartan potassium ................................................................ 2925Loss on drying (2.2.32.) .................................................. 9.4-5099Loss on drying of extracts (2.8.17.) ........................................ 289Lovage root .............................................................................. 1420Lovastatin ................................................................................ 2927Low-molecular-mass heparins.............................................. 2646Low-substituted hydroxypropylcellulose ...................... 9.5-5691Lozenges and pastilles ..................................................... 9.3-4789



Lozenges, compressed ..................................................... 9.3-4789Lubricant, silicone oil (3.1.8.).................................................. 408Lufenuron for veterinary use ................................................ 2929Lutetium (177Lu) solution for radiolabelling................. 9.3-4799Lycopus lucidus herb....................................................... 9.1-4105Lymecycline............................................................................. 2930Lynestrenol .............................................................................. 2932Lyophilisates, oral ............................................................ 9.3-4792Lysine acetate .......................................................................... 2933Lysine hydrochloride.............................................................. 2935

MMacrogol 15 hydroxystearate ................................................ 2939Macrogol 20 glycerol monostearate...................................... 2940Macrogol 30 dipolyhydroxystearate ..................................... 2941Macrogol 40 sorbitol heptaoleate.......................................... 2941Macrogol 6 glycerol caprylocaprate...................................... 2939Macrogol cetostearyl ether .................................................... 2942Macrogolglycerol cocoates..................................................... 2948Macrogolglycerol hydroxystearate ........................................ 2949Macrogolglycerol ricinoleate ................................................. 2950Macrogol isotridecyl ether..................................................... 2943Macrogol lauryl ether............................................................. 2943Macrogol oleate....................................................................... 2944Macrogol oleyl ether............................................................... 2945Macrogol poly(vinyl alcohol) grafted copolymer ............... 2945Macrogols ................................................................................ 2950Macrogols, high-molecular-mass ......................................... 2952Macrogol stearate.................................................................... 2947Macrogol stearyl ether ........................................................... 2947Magaldrate ............................................................................... 2953Magnesium (2.4.6.)................................................................... 132Magnesium acetate tetrahydrate ........................................... 2954Magnesium aluminium silicate...................................... 9.3-4839Magnesium aluminometasilicate ................................... 9.7-6641Magnesium and alkaline-earth metals (2.4.7.)...................... 133Magnesium aspartate dihydrate..................................... 9.3-4951Magnesium carbonate, heavy................................................ 2955Magnesium carbonate, light .................................................. 2956Magnesium chloride 4.5-hydrate .......................................... 2957Magnesium chloride hexahydrate ........................................ 2957Magnesium citrate .................................................................. 2958Magnesium citrate dodecahydrate........................................ 2959Magnesium citrate nonahydrate ........................................... 2959Magnesium fluoratum for homoeopathic preparations..... 1609Magnesium gluconate ............................................................ 2960Magnesium glycerophosphate............................................... 2960Magnesium hydroxide............................................................ 2961Magnesium lactate dihydrate ................................................ 2961Magnesium oxide, heavy ....................................................... 2962Magnesium oxide, light.......................................................... 2963Magnesium peroxide.............................................................. 2963Magnesium phosphoricum for homoeopathicpreparations .......................................................................... 1609

Magnesium pidolate ............................................................... 2964Magnesium stearate................................................................ 2965Magnesium sulfate heptahydrate .......................................... 2968Magnesium trisilicate ............................................................. 2968Magnolia biondii flower bud.......................................... 9.3-4817Magnolia officinalis bark ................................................ 9.2-4467Magnolia officinalis flower ............................................. 9.3-4819Maize oil, refined .................................................................... 2969Maize starch ............................................................................ 2969Malathion................................................................................. 2970Maleic acid............................................................................... 2971Malic acid ................................................................................ 2972Mallow flower.......................................................................... 1424Mallow leaf .............................................................................. 1425Maltitol..................................................................................... 2973Maltitol, liquid ........................................................................ 2974Maltodextrin............................................................................ 2975Mandarin epicarp and mesocarp.......................................... 1426

Mandarin oil............................................................................ 1428Manganese gluconate ............................................................. 2976Manganese glycerophosphate, hydrated .............................. 2976Manganese sulfate monohydrate ................................... 9.2-4567Mannheimia vaccine (inactivated) for cattle....................... 1071Mannheimia vaccine (inactivated) for sheep ...................... 1072Mannitol ........................................................................... 9.2-4567Maprotiline hydrochloride .................................................... 2980Marbofloxacin for veterinary use ......................................... 2981Marek’s disease vaccine (live) ................................................ 1073Marshmallow leaf ................................................................... 1429Marshmallow root .................................................................. 1430Mass spectrometry (2.2.43.) ...................................................... 71Mass spectrometry, inductively coupled plasma- (2.2.58.).. 101Mass uniformity of delivered doses from multidose containers(2.9.27.) .................................................................................... 347

Mass uniformity of single-dose preparations (2.9.5.) .......... 311Mastic ....................................................................................... 1430Mate leaf............................................................................ 9.4-5309Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) .................................................................................... 410

Materials based on non-plasticised poly(vinyl chloride) forcontainers for solid dosage forms for oral administration(3.1.11.) .................................................................................... 412

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ........................................................................... 9.6-5852

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) .......................................................................... 9.6-5843

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).................................................... 9.6-5846

Materials for containers for human blood and bloodcomponents (3.1.1.)................................................................ 391

Materials used for the manufacture of containers (3.1.)...... 391Matricaria flower .................................................................... 1431Matricaria liquid extract ........................................................ 1433Matricaria oil........................................................................... 1434Meadowsweet .......................................................................... 1436Measles immunoglobulin, human ........................................ 2685Measles, mumps and rubella vaccine (live) .................. 9.6-5945Measles, mumps, rubella and varicella vaccine (live).. 9.6-5946Measles vaccine (live)...................................................... 9.6-5947Measurement and detection of radioactivity (2.2.66.) ......... 113Measurement of consistency by penetrometry (2.9.9.)........ 313Mebendazole ........................................................................... 2983Meclozine dihydrochloride............................................. 9.4-5403Medicated chewing gums ............................................... 9.3-4784Medicated chewing gums, dissolution test for (2.9.25.)....... 340Medicated feeding stuffs for veterinary use, premixes for .. 875Medicated foams....................................................................... 859Medicated plasters .................................................................... 884Medicated tampons .................................................................. 887Medicated vaginal tampons..................................................... 889Medicinal air ........................................................................... 1653Medicinal air, synthetic.......................................................... 1655Medium-chain triglycerides .................................................. 3839Medronic acid for radiopharmaceutical preparations.. 9.2-4437Medroxyprogesterone acetate................................................ 2985Mefenamic acid....................................................................... 2987Mefloquine hydrochloride ..................................................... 2989Megestrol acetate .................................................................... 2990Meglumine............................................................................... 2992Meldonium dihydrate............................................................. 2993Melilot ...................................................................................... 1437Melissa leaf .............................................................................. 1438Melissa leaf dry extract .......................................................... 1439Meloxicam ............................................................................... 2994Melphalan ................................................................................ 2996Melting point - capillary method (2.2.14.) ................... 9.1-4037Melting point - instantaneous method (2.2.16.) ..................... 33



Melting point - open capillary method (2.2.15.) .................... 32Menadione............................................................................... 2998Meningococcal group C and haemophilus type b conjugatevaccine ..................................................................................... 926

Meningococcal group C conjugate vaccine .................. 9.6-5949Meningococcal polysaccharide vaccine ........................ 9.6-5950Menthol, racemic .................................................................... 2998Mepivacaine hydrochloride ............................................ 9.6-6155Meprobamate .......................................................................... 3001Mepyramine maleate.............................................................. 3001Mercaptopurine ...................................................................... 3003Mercuric chloride ................................................................... 3003Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352

Meropenem trihydrate ........................................................... 3004Mesalazine ........................................................................ 9.6-6156Mesna ................................................................................ 9.2-4569Mesterolone ............................................................................. 3009Mestranol ................................................................................. 3010Metabisulfite, potassium ........................................................ 3386Metabisulfite, sodium............................................................. 3591Metacresol................................................................................ 3011Metal catalyst or metal reagent residues (5.20.)........... 9.3-4759Metal catalyst or metal reagent residues, determination of(2.4.20.) ........................................................................... 9.6-5833

Metamizole sodium monohydrate........................................ 3012Metered-dose preparations for inhalation, non-pressurised...................................................................... 9.4-5291

Metered-dose preparations for inhalation, pressurised ...... 9.4-5289

Metformin hydrochloride...................................................... 3014Methacrylate copolymer, basic butylated .....................9.4-5325Methacrylic acid - ethyl acrylate copolymer (1:1)....... 9.6-6159Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ............................................................................. 3017

Methacrylic acid - methyl methacrylate copolymer (1:1).. 3018Methacrylic acid - methyl methacrylate copolymer (1:2).. 3019Methadone hydrochloride ..................................................... 3020Methane ................................................................................... 3021Methane intermix (2 per cent) in nitrogen .................. 9.3-4953Methanesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.38.)................................................................. 177

Methanesulfonic acid, methanesulfonyl chloride in(2.5.39.) .................................................................................... 178

Methanesulfonic acid, methyl, ethyl and isopropylmethanesulfonate in (2.5.37.)................................................ 176

Methanesulfonyl chloride in methanesulfonic acid(2.5.39.) .................................................................................... 178

Methanol.................................................................................. 3022Methanol and 2-propanol, test for (2.9.11.) .......................... 318Methenamine .......................................................................... 3023Methionine .............................................................................. 3024Methionine ([11C]methyl) injection, L- ................................ 1161Methionine, DL- ...................................................................... 3025Methods in pharmacognosy (2.8.).......................................... 283Methods of preparation of homoeopathic stocks andpotentisation .................................................................. 9.2-4479

Methods of preparation of sterile products (5.1.1.) .... 9.2-4333Methotrexate ........................................................................... 3026Methylcellulose ................................................................ 9.6-6160Methyldopa.............................................................................. 3033Methylene blue........................................................................ 3049Methylene chloride................................................................. 3034Methylergometrine maleate .................................................. 3035Methyl, ethyl and isopropyl benzenesulfonate in activesubstances (2.5.41).................................................................. 180

Methyl, ethyl and isopropyl methanesulfonate in activesubstances (2.5.38.)................................................................. 177

Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid (2.5.37.) .............................................. 176

Methyl, ethyl and isopropyl toluenesulfonate in activesubstances (2.5.40.)................................................................. 179

Methylhydroxyethylcellulose................................................. 3037

Methyl methacrylate – methacrylic acid copolymer (1:1).. 3018Methyl methacrylate - methacrylic acid copolymer (1:2).. 3019Methyl nicotinate.................................................................... 3028Methyl parahydroxybenzoate................................................ 3029Methyl parahydroxybenzoate, sodium................................. 3591Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 167Methylphenidate hydrochloride ........................................... 3037Methylphenobarbital .............................................................. 3039Methylprednisolone................................................................ 3040Methylprednisolone acetate............................................9.4-5404Methylprednisolone hydrogen succinate ............................. 3044Methylpyrrolidone, N- ........................................................... 3046Methylrosanilinium chloride ......................................... 9.4-5406Methyl salicylate ..................................................................... 3030Methyltestosterone ................................................................. 3048Methylthioninium chloride ................................................... 3049Metixene hydrochloride......................................................... 3050Metoclopramide............................................................... 9.4-5407Metoclopramide hydrochloride monohydrate............. 9.4-5409Metolazone .............................................................................. 3053Metoprolol succinate .............................................................. 3055Metoprolol tartrate ................................................................. 3056Metrifonate .............................................................................. 3058Metronidazole ......................................................................... 3059Metronidazole benzoate......................................................... 3060Mexiletine hydrochloride ...................................................... 3062Mianserin hydrochloride ....................................................... 3063Miconazole ....................................................................... 9.7-6642Miconazole nitrate........................................................... 9.7-6643Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) .............................................. 195

Microbiological assay of antibiotics (2.7.2.) ................. 9.7-6309Microbiological examination of cell-based preparations(2.6.27.) ........................................................................... 9.2-4297

Microbiological examination of herbal medicinal products fororal use and extracts used in their preparation (2.6.31.)... 232

Microbiological examination of live biotherapeuticproducts: tests for enumeration of microbial contaminants(2.6.36.) ........................................................................... 9.7-6297

Microbiological examination of live biotherapeutic products:tests for specified micro-organisms (2.6.38.) ............. 9.7-6301

Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) .................................. 195

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..................................... 199

Microbiological quality, alternative methods for control of(5.1.6.) ............................................................................. 9.2-4339

Microbiological quality of herbal medicinal products for oraluse and extracts used in their preparation (5.1.8.).... 9.7-6474

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.) ............................................................................. 9.7-6473

Microbiology, general texts on (5.1.) ..................................... 575Microcalorimetry and solution calorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109

Microcrystalline cellulose ............................................... 9.6-6052Microcrystalline cellulose and carmellose sodium ............ 3068Micro determination of water (2.5.32.)......................... 9.4-5107Microscopic examination of herbal drugs (2.8.23) .............. 295Microscopy, optical (2.9.37.) ................................................... 365Midazolam............................................................................... 3069Milbemycin oxime for veterinary use ........................... 9.6-6162Milk thistle dry extract, refined and standardised ...... 9.6-5998Milk thistle fruit...................................................................... 1441Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613

Minocycline hydrochloride dihydrate........................... 9.2-4573Minoxidil ................................................................................. 3072Mint oil, partly dementholised ............................................. 1443Mirtazapine ............................................................................. 3074Misoprostol.............................................................................. 3075Mites for allergen products ................................................... 3077



Mitomycin ............................................................................... 3078Mitoxantrone hydrochloride ................................................. 3079Modafinil ................................................................................. 3081Modified-release capsules ............................................... 9.4-5288Modified-release granules............................................... 9.6-5913Modified-release tablets .................................................. 9.3-4791Mofetil mycophenolate .......................................................... 3104Molecular mass distribution in dextrans (2.2.39.).................. 62Molgramostim concentrated solution........................... 9.5-5719Molsidomine ........................................................................... 3084Molybdate dihydrate, sodium ........................................ 9.7-6682Mometasone furoate........................................................ 9.5-5721Mometasone furoate monohydrate ............................... 9.5-5724Monoclonal antibodies for human use .................................. 826Monocyte-activation test (2.6.30.) ................................. 9.2-4299Monographs on herbal drug extracts (information chapter)(5.23.) .............................................................................. 9.7-6515

Monophosphoryl lipid A, 3-O-desacyl-4- .......................... 2207Montelukast sodium........................................................ 9.1-4179Morantel hydrogen tartrate for veterinary use ................... 3090Morphine hydrochloride ....................................................... 3091Morphine sulfate..................................................................... 3093Moss, Iceland........................................................................... 1392Mother tinctures for homoeopathic preparations .............. 1571Motherwort ............................................................................. 1444Moulds for allergen products ................................................ 3094Moutan bark..................................................................... 9.4-5311Mouthwashes.................................................................... 9.3-4788Moxidectin for veterinary use............................................... 3095Moxifloxacin hydrochloride .................................................. 3098Moxonidine ............................................................................. 3100Mucoadhesive preparations............................................ 9.3-4789Mullein flower ......................................................................... 1445Multidose containers, uniformity of mass of delivered doses(2.9.27.) .................................................................................... 347

Mumps, measles and rubella vaccine (live).................. 9.6-5945Mumps, measles, rubella and varicella vaccine (live).. 9.6-5946Mumps vaccine (live) ...................................................... 9.6-5952Mupirocin ......................................................................... 9.7-6645Mupirocin calcium .......................................................... 9.7-6647Mycobacteria (2.6.2.)................................................................ 188Mycophenolate mofetil .......................................................... 3104Mycophenolate sodium.......................................................... 3105Mycoplasma gallisepticum vaccine (inactivated) ............... 1075Mycoplasmas (2.6.7.)................................................................ 188myo-Inositol ............................................................................ 2761Myrrh ................................................................................ 9.2-4468Myrrh tincture ................................................................. 9.2-4469Myxomatosis vaccine (live) for rabbits ................................ 1076

NNabumetone ............................................................................ 3109N-Acetyltryptophan ............................................................... 1639N-Acetyltyrosine ..................................................................... 1641Nadolol..................................................................................... 3110Nadroparin calcium ........................................................9.5-5731Naftidrofuryl hydrogen oxalate ............................................ 3113Nalidixic acid .......................................................................... 3115Naloxone hydrochloride dihydrate................................ 9.3-4957Naltrexone hydrochloride...................................................... 3118Names of herbal drugs used in traditional Chinese medicine(5.22.) .............................................................................. 9.7-6511

Nandrolone decanoate ........................................................... 3120Naphazoline hydrochloride ................................................... 3122Naphazoline nitrate ................................................................ 3123Naproxen ................................................................................. 3124Naproxen sodium ................................................................... 3126Narrow-leaved coneflower root ............................................ 1447Nasal drops and liquid nasal sprays ....................................... 867Nasal powders ........................................................................... 867Nasal preparations .................................................................... 866Nasal preparations, semi-solid................................................ 868

Nasal sprays (liquid) and nasal drops .................................... 866Nasal sticks ................................................................................ 868Nasal washes.............................................................................. 868Nateglinide .............................................................................. 3128Near-infrared spectroscopy (2.2.40.)........................................ 64Nebulisation, characterisation of preparations for(2.9.44.) .................................................................................... 378

Nebulisation, liquid preparations for ............................ 9.4-5289Neohesperidin-dihydrochalcone .......................................... 3130Neomycin sulfate .................................................................... 3132Neonatal piglet colibacillosis vaccine (inactivated)............ 1077Neonatal ruminant colibacillosis vaccine (inactivated)..... 1079Neostigmine bromide............................................................. 3134Neostigmine metilsulfate ................................................ 9.5-5733Neroli oil .................................................................................. 1449Netilmicin sulfate............................................................. 9.2-4579Nettle leaf................................................................................. 1450Nettle root................................................................................ 1452Neurovirulence test of live viral vaccines (2.6.18.) ............... 212Nevirapine ........................................................................ 9.3-4959Nevirapine hemihydrate ........................................................ 3139Newcastle disease vaccine (inactivated)............................... 1080Newcastle disease vaccine (live)............................................ 1082Niaouli oil, cineole type ......................................................... 1453Nicardipine hydrochloride ............................................. 9.3-4960Nicergoline ....................................................................... 9.7-6651Nickel in hydrogenated vegetable oils (2.4.31.) ........... 9.4-5103Nickel in polyols (2.4.15.) ........................................................ 137Niclosamide............................................................................. 3142Niclosamide monohydrate .................................................... 3143Nicorandil................................................................................ 3144Nicotinamide........................................................................... 3145Nicotine.................................................................................... 3146Nicotine ditartrate dihydrate................................................. 3147Nicotine resinate ..................................................................... 3148Nicotinic acid ................................................................... 9.3-4961Nifedipine ................................................................................ 3151Niflumic acid........................................................................... 3152Nifuroxazide............................................................................ 3154Nikethamide............................................................................ 3155Nilutamide............................................................................... 3156Nimesulide............................................................................... 3157Nimodipine ............................................................................. 3158Nitrazepam.............................................................................. 3159Nitrendipine ............................................................................ 3160Nitric acid ................................................................................ 3161Nitric oxide.............................................................................. 3162Nitrofural ................................................................................. 3163Nitrofurantoin......................................................................... 3164Nitrogen ................................................................................... 3165Nitrogen determination by sulfuric acid digestion (2.5.9.).. 164Nitrogen determination, primary aromatic amino (2.5.8.).. 163Nitrogen, low-oxygen............................................................. 3166Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) .................................................................................... 170

Nitroprusside, sodium ........................................................... 3593Nitrous oxide........................................................................... 3166Nitrous oxide in gases (2.5.35.)............................................... 176Nizatidine ................................................................................ 3167N-Methylpyrrolidone ............................................................. 3046NMR spectrometry (2.2.33.) ..................................................... 54NMR spectrometry, peptide identification by (2.2.64.)....... 112N,N-Dimethylaniline (2.4.26.) ................................................ 152Nomegestrol acetate ............................................................... 3169Nonoxinol 9............................................................................. 3170Non-sterile pharmaceutical preparations and substancesfor pharmaceutical use, microbiological quality of(5.1.4.) ............................................................................. 9.7-6473

Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ............................... 195

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.).................................... 199

Noradrenaline hydrochloride......................................... 9.3-4962



Noradrenaline tartrate .................................................... 9.3-4964Norepinephrine hydrochloride ...................................... 9.3-4962Norepinephrine tartrate.................................................. 9.3-4964Norethisterone ........................................................................ 3174Norethisterone acetate ........................................................... 3175Norfloxacin....................................................................... 9.7-6653Norflurane ............................................................................... 3179Norgestimate ........................................................................... 3184Norgestrel ................................................................................ 3185Normal immunoglobulin for intramuscular administration,human .................................................................................... 2685

Normal immunoglobulin for intravenous administration,human .................................................................................... 2687

Normal immunoglobulin for subcutaneous administration,human .................................................................................... 2689

Nortriptyline hydrochloride........................................... 9.7-6654Noscapine ................................................................................ 3187Noscapine hydrochloride hydrate......................................... 3188Notoginseng root .................................................................... 1454Nuclear magnetic resonance spectrometry (2.2.33.).............. 54Nuclear magnetic resonance spectrometry, peptideidentification by (2.2.64.)....................................................... 112

Nucleated cell count and viability (2.7.29.) ........................... 275Nucleic acid amplification techniques (2.6.21.) .................... 214Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 166Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) .................................................................................... 269

Nutmeg oil ............................................................................... 1455Nux-vomica for homoeopathic preparations ............... 9.3-4829Nystatin............................................................................. 9.6-6167

OO-Acetyl in polysaccharide vaccines (2.5.19.)....................... 167Oak bark .................................................................................. 1456Octoxinol 10............................................................................ 3193Octyldodecanol ................................................................ 9.4-5421Octyl gallate............................................................................. 3193Odour (2.3.4.)............................................................................ 127Odour and taste of essential oils (2.8.8.)................................ 284Ofloxacin.................................................................................. 3195Oils, essential............................................................................. 814Oils, fatty, identification by thin-layer chromatography(2.3.2.) ............................................................................. 9.6-5829

Oils, fatty, vegetable.................................................................. 848Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) ........................................................................... 9.7-6293

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 157Ointments .................................................................................. 883Olanzapine............................................................................... 3196Oleic acid ................................................................................. 3197Oleoresins ......................................................................... 9.7-6521Oleoyl macrogolglycerides ............................................. 9.1-4185Oleyl alcohol............................................................................ 3199Olive leaf .................................................................................. 1456Olive leaf dry extract .............................................................. 1458Olive oil, refined .............................................................. 9.3-4973Olive oil, virgin ................................................................ 9.3-4973Olmesartan medoxomil ......................................................... 3201Olsalazine sodium .................................................................. 3203Omega-3-acid ethyl esters 60 ................................................ 3205Omega-3-acid ethyl esters 90 ......................................... 9.2-4583Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) ........................................................................... 9.7-6293

Omega-3 acids, fish oil rich in .............................................. 2474Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 157Omega-3-acid triglycerides ................................................... 3209Omeprazole ............................................................................. 3211Omeprazole magnesium........................................................ 3213Omeprazole sodium ............................................................... 3214Ondansetron hydrochloride dihydrate ................................ 3216Opalescence of liquids, clarity and degree of (2.2.1.) ..9.2-4285Ophthalmic inserts ................................................................... 858

Opium dry extract, standardised.......................................... 1459Opium, prepared .................................................................... 1460Opium, raw.............................................................................. 1461Opium tincture, standardised ............................................... 1463Optical microscopy (2.9.37.) ................................................... 365Optical rotation (2.2.7.) .................................................. 9.5-5535Oral drops......................................................................... 9.3-4786Oral lyophilisates ............................................................. 9.3-4792Oral powders............................................................................. 874Oral solutions, emulsions and suspensions.................. 9.3-4786Oral use, liquid preparations for ................................... 9.3-4785Oral use, veterinary semi-solid preparations for .................. 890Orbifloxacin for veterinary use............................................. 3217Orciprenaline sulfate .............................................................. 3219Oregano ................................................................................... 1464Organ preservation, solutions for......................................... 3612Oriental cashew for homoeopathic preparations ............... 1591Orientvine stem ...................................................................... 1466Orodispersible films ........................................................ 9.3-4790Orodispersible tablets ..................................................... 9.3-4792Oromucosal capsules....................................................... 9.3-4789Oromucosal drops, oromucosal sprays and sublingualsprays............................................................................... 9.3-4788

Oromucosal preparations ............................................... 9.3-4787Oromucosal preparations, semi-solid ........................... 9.3-4788Oromucosal solutions and oromucosal suspensions... 9.3-4788Oromucosal sprays, oromucosal drops and sublingualsprays............................................................................... 9.3-4787

Oromucosal suspensions and oromucosal solutions... 9.3-4787Orphenadrine citrate.............................................................. 3220Orphenadrine hydrochloride ................................................ 3222Oseltamivir phosphate .................................................... 9.2-4585Osmolality (2.2.35.) .................................................................... 59Ouabain ................................................................................... 3225Oxacillin sodium monohydrate ............................................ 3226Oxaliplatin ............................................................................... 3228Oxazepam................................................................................ 3231Oxcarbazepine......................................................................... 3232Oxeladin hydrogen citrate ..................................................... 3234Oxfendazole for veterinary use ............................................. 3235Oxidising substances (2.5.30.)................................................. 171Oxitropium bromide .............................................................. 3236Oxolinic acid ........................................................................... 3237Oxybuprocaine hydrochloride .............................................. 3239Oxybutynin hydrochloride .................................................... 3241Oxycodone hydrochloride ..................................................... 3242Oxygen ..................................................................................... 3243Oxygen (15O) ........................................................................... 1163Oxygen (93 per cent).............................................................. 3244Oxygen-flask method (2.5.10.)................................................ 164Oxygen in gases (2.5.27.) ......................................................... 170Oxymetazoline hydrochloride............................................... 3245Oxytetracycline dihydrate...................................................... 3247Oxytetracycline hydrochloride.............................................. 3249Oxytocin .................................................................................. 3250Oxytocin concentrated solution............................................ 3251

PPaclitaxel ........................................................................... 9.7-6659Pale coneflower root............................................................... 1467Palmitic acid............................................................................ 3259Pamidronate disodium pentahydrate................................... 3259Pancreas powder ..................................................................... 3260Pancuronium bromide ........................................................... 3263Panleucopenia vaccine (inactivated), feline ........................ 1056Panleucopenia vaccine (live), feline ..................................... 1057Pansy, wild (flowering aerial parts)...................................... 1558Pantoprazole sodium sesquihydrate.............................. 9.6-6171Pantothenate, calcium............................................................ 1929Papaverine hydrochloride...................................................... 3265Paper chromatography (2.2.26.) ............................................... 42Papillomavirus vaccine (rDNA), human ..................... 9.6-5931



Paraben, butyl ......................................................................... 1892Paraben, ethyl.......................................................................... 2428Paraben, methyl ...................................................................... 3029Paraben, propyl ....................................................................... 3436Paraben, sodium ethyl............................................................ 3577Paraben, sodium methyl ........................................................ 3591Paraben, sodium propyl......................................................... 3599Paracetamol ...................................................................... 9.4-5429Paraffin, hard........................................................................... 3268Paraffin, light liquid ........................................................ 9.5-5737Paraffin, liquid ................................................................. 9.5-5737Paraffin, white soft.................................................................. 3270Paraffin, yellow soft ................................................................ 3271Parahydroxybenzoate, butyl .................................................. 1892Parahydroxybenzoate, ethyl .................................................. 2428Parahydroxybenzoate, methyl ............................................... 3029Parahydroxybenzoate, propyl................................................ 3436Parahydroxybenzoate, sodium ethyl .................................... 3577Parahydroxybenzoate, sodium methyl................................. 3591Parahydroxybenzoate, sodium propyl.................................. 3599Parainfluenza virus vaccine (live), bovine ........................... 1021Parainfluenza virus vaccine (live), canine ........................... 1032Paraldehyde ............................................................................. 3271Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ....................................................................................... 1080

Paramyxovirus 1 (Newcastle disease) vaccine (live),avian ....................................................................................... 1082

Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1016Parenteral preparations............................................................ 871Parenteral preparations, test for extractable volume of(2.9.17.) .................................................................................... 322

Parnaparin sodium................................................................. 3272Paroxetine hydrochloride ...................................................... 3272Paroxetine hydrochloride hemihydrate ............................... 3275Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ................................................................. 323

Particle size analysis by laser light diffraction(2.9.31.) ........................................................................... 9.7-6320

Particle-size distribution estimation by analytical sieving(2.9.38.) .................................................................................... 367

Particulate contamination : sub-visible particles (2.9.19.) ... 335Particulate contamination : visible particles (2.9.20.)........... 337Parvovirosis vaccine (inactivated), canine........................... 1033Parvovirosis vaccine (inactivated), porcine......................... 1089Parvovirosis vaccine (live), canine........................................ 1034Passion flower ......................................................................... 1469Passion flower dry extract ..................................................... 1470Pastes .......................................................................................... 884Pasteurella vaccine (inactivated) for sheep.......................... 1084Pastilles and lozenges ...................................................... 9.3-4789Patches, cutaneous.................................................................... 882Patches, transdermal ................................................................ 873Patches, transdermal, dissolution test for (2.9.4.)................. 309Pea starch................................................................................. 3277Pefloxacin mesilate dihydrate................................................ 3277Pelargonium root .................................................................... 1470Pemetrexed disodium heptahydrate..................................... 3279Penbutolol sulfate ................................................................... 3281Penetrometry, measurement of consistency by (2.9.9.) ....... 313Penicillamine........................................................................... 3282Penicillin G (benzathine) tetrahydrate.......................... 9.6-6037Penicillin G potassium.................................................... 9.2-4505Penicillin G, procaine...................................................... 9.2-4506Penicillin G sodium......................................................... 9.2-4508Penicillin V....................................................................... 9.1-4189Penicillin V (benzathine) tetrahydrate.......................... 9.6-6177Penicillin V potassium .................................................... 9.1-4190Pentaerythrityl tetranitrate, diluted...................................... 3284Pentamidine diisetionate ....................................................... 3286Pentazocine.............................................................................. 3287Pentazocine hydrochloride.................................................... 3287Pentazocine lactate ................................................................. 3288

Pentetate sodium calcium for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Pentobarbital .................................................................... 9.6-6172Pentobarbital sodium ...................................................... 9.6-6174Pentoxifylline .......................................................................... 3290Pentoxyverine hydrogen citrate ............................................ 3292Peony root, red........................................................................ 1471Peony root, white .................................................................... 1472Pepper ...................................................................................... 1474Pepper, long............................................................................. 1417Peppermint leaf................................................................ 9.2-4469Peppermint leaf dry extract............................................ 9.2-4471Peppermint oil ................................................................. 9.7-6552Pepsin powder......................................................................... 3293Peptide identification by nuclear magnetic resonancespectrometry (2.2.64.) ............................................................ 112

Peptide mapping (2.2.55.).......................................................... 90Peptides, synthetic, acetic acid in (2.5.34.) ............................ 175Perborate, hydrated sodium .................................................. 3594Pergolide mesilate ................................................................... 3295Perindopril tert-butylamine .................................................. 3296Peritoneal dialysis, solutions for .................................... 9.6-6175Permethrin (25:75) ................................................................. 3301Peroxide value (2.5.5.) .............................................................. 162Perphenazine........................................................................... 3303Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed) ................................................................. 902

Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed, reduced antigen(s) content)................. 903

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ... 9.6-5920

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ... 9.5-5585

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ........................................................ 9.5-5587

Pertussis toxin (residual) and pertussis toxoid (irreversibilityof) (2.6.33.).............................................................................. 235

Pertussis vaccine (acellular), assay of (2.7.16.)...................... 263Pertussis vaccine (acellular, component, adsorbed)............. 960Pertussis vaccine (acellular, co-purified, adsorbed) ............. 962Pertussis vaccine (whole cell, adsorbed)................................ 963Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 252Pertussis (whole cell), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 905

Pertussis (whole cell), diphtheria, tetanus and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Pertussis (whole cell), diphtheria, tetanus, poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ...................................................................... 9.5-5590

Peru balsam ............................................................................. 1479Pessaries ..................................................................................... 888Pessaries and suppositories, disintegration of (2.9.2.) ......... 301Pesticide residues (2.8.13.).............................................. 9.6-5839Pethidine hydrochloride ........................................................ 3304Petroleum rectificatum for homoeopathic preparations ... 1612Pharmaceutical preparations.......................................... 9.7-6523Pharmaceutical technical procedures (2.9.) .......................... 299Pharmacognosy, methods in (2.8.)......................................... 283Pharmacopoeial harmonisation (5.8.) .......................... 9.7-6477Phenazone................................................................................ 3305Pheniramine maleate.............................................................. 3306Phenobarbital .......................................................................... 3307Phenobarbital sodium............................................................ 3309Phenol ...................................................................................... 3310



Phenol in immunosera and vaccines (2.5.15.) ...................... 166Phenolphthalein...................................................................... 3311Phenolsulfonphthalein ........................................................... 3311Phenothiazines, identification by thin-layer chromatography(2.3.3.) ...................................................................................... 127

Phenoxyethanol ...................................................................... 3312Phenoxymethylpenicillin ................................................ 9.1-4189Phenoxymethylpenicillin (benzathine) tetrahydrate...9.6-6177Phenoxymethylpenicillin potassium ............................. 9.1-4190Phentolamine mesilate ........................................................... 3317Phenylalanine .......................................................................... 3318Phenylbutazone....................................................................... 3319Phenylbutyrate, sodium ......................................................... 3595Phenylephrine ......................................................................... 3321Phenylephrine hydrochloride................................................ 3322Phenylmercuric acetate .......................................................... 3324Phenylmercuric borate........................................................... 3324Phenylmercuric nitrate .......................................................... 3325Phenylpropanolamine hydrochloride .................................. 3325Phenytoin.......................................................................... 9.6-6179Phenytoin sodium............................................................ 9.6-6180Phloroglucinol.................................................................. 9.7-6663Phloroglucinol dihydrate ................................................ 9.7-6665pH of solutions, approximate (2.2.4.)....................................... 25Pholcodine monohydrate ............................................... 9.1-4192Phosphates (2.4.11.).................................................................. 136Phospholipids for injection, egg .................................... 9.2-4533Phospholipids for injection, soya................................... 9.4-5445Phosphoric acid, concentrated.............................................. 3333Phosphoric acid, dilute .......................................................... 3334Phosphorus in polysaccharide vaccines (2.5.18.) ................. 166pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole .............................................................. 3334Physical and physicochemical methods (2.2.) ........................ 21Physostigmine salicylate ........................................................ 3335Phytomenadione, racemic .............................................. 9.6-6182Phytosterol............................................................................... 3337Picosulfate, sodium ................................................................ 3596Picotamide monohydrate....................................................... 3338Picric acid for homoeopathic preparations ......................... 1587Piglet colibacillosis vaccine (inactivated), neonatal ........... 1077Pillules for homoeopathic preparations............................... 1586Pillules, homoeopathic, coated ............................................. 1587Pillules, homoeopathic, impregnated............................ 9.1-4118Pilocarpine hydrochloride ..................................................... 3339Pilocarpine nitrate .................................................................. 3340Pimobendan for veterinary use...................................... 9.5-5738Pimozide .................................................................................. 3343Pindolol.................................................................................... 3344Pine (dwarf) oil....................................................................... 1340Pine sylvestris oil .................................................................... 1480Pioglitazone hydrochloride ................................................... 3345Pipemidic acid trihydrate ...................................................... 3346Piperacillin............................................................................... 3347Piperacillin sodium ................................................................ 3349Piperazine adipate .................................................................. 3351Piperazine citrate .................................................................... 3352Piperazine hydrate .................................................................. 3352Piracetam................................................................................. 3353Pirenzepine dihydrochloride monohydrate ........................ 3354Piretanide................................................................................. 3356Pirfenidone .............................................................................. 3357Piroxicam................................................................................. 3358Pivampicillin ........................................................................... 3359Pivmecillinam hydrochloride................................................ 3361Plasma for fractionation, human.......................................... 2691Plasma (pooled and treated for virus inactivation),human .............................................................................9.2-4555

Plasmid vectors for human use, bacterial cells used for themanufacture of............................................................... 9.7-6499

Plasmin inhibitor, assay of human (2.7.25.).......................... 272Plasters, medicated ................................................................... 882Plastic additives (3.1.13.) ................................................ 9.6-5849

Plastic containers and closures for pharmaceutical use(3.2.2.) ...................................................................................... 428

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ................................................................................... 429

Plastic containers for human blood and blood components,sterile (3.2.3.).................................................................. 9.6-5865

Plastic syringes, single-use, sterile (3.2.8.)............................. 434Platycodon root................................................................ 9.6-5999Pneumococcal polysaccharide conjugate vaccine(adsorbed) ...................................................................... 9.6-5953

Pneumococcal polysaccharide vaccine ......................... 9.6-5955Pneumonia vaccine (inactivated), porcine enzootic .......... 1086Podophyllotoxin............................................................... 9.6-6184Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content)............................... 906

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 911

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content).................................................................................... 913

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(whole cell) vaccine (adsorbed) ............................................ 920

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed) ........................................................ 9.5-5587

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ........................... 9.5-5585

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(whole cell) and haemophilus type b conjugate vaccine(adsorbed) ...................................................................... 9.5-5590

Poliomyelitis vaccine (inactivated) ................................ 9.6-5957Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .................................................................................... 267

Poliomyelitis vaccine (oral) ............................................ 9.1-4091Pollens for allergen products................................................. 3362Poloxamers ....................................................................... 9.7-6666Polyacrylate dispersion 30 per cent ...................................... 3365Polyamide 6/6 suture, sterile, in distributor for veterinaryuse.................................................................................... 9.5-5609

Polyamide 6 suture, sterile, in distributor for veterinary use......................................................................................... 9.5-5609

Polyethyleneglycols................................................................. 2950Polyethyleneglycols, high-molecular-mass.......................... 2952Polyethylene oxides, high-molecular-mass ......................... 2952Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .................................................... 419

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use................................................................. 9.5-5609

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.).......... 9.2-4318

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations(3.1.5.) ............................................................................. 9.4-5120

Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations(3.1.4.) ............................................................................. 9.2-4310

Polygonum cuspidatum rhizome and root.......................... 1481Polygonum orientale fruit .............................................. 9.2-4472Polymorphism (5.9.)................................................................. 719Polymyxin B sulfate ......................................................... 9.7-6668Polyolefins (3.1.3.) ........................................................... 9.4-5117Polyoxyl castor oil................................................................... 2950Polyoxyl hydrogenated castor oil .......................................... 2949Polyoxypropylene stearyl ether ...................................... 9.5-5739Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)... 9.4-5123

Polysaccharide vaccines for human use, conjugated, carrierproteins for the production of (5.2.11.) ............................... 626

Polysaccharide vaccines, hexosamines in (2.5.20.) ............... 167Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 167Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 166Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 167



Polysaccharide vaccines, phosphorus in (2.5.18.)................. 166Polysaccharide vaccines, protein in (2.5.16.)......................... 166Polysaccharide vaccines, ribose in (2.5.31.) .......................... 171Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 168Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 168Polysorbate 20 ......................................................................... 3368Polysorbate 40 ......................................................................... 3369Polysorbate 60 ......................................................................... 3370Polysorbate 80 .................................................................. 9.2-4591Polystyrene sulfonate, sodium .............................................. 3597Poly(vinyl acetate) ........................................................... 9.3-4977Poly(vinyl acetate) dispersion 30 per cent .................... 9.3-4978Poly(vinyl alcohol)........................................................... 9.3-4979Poly(vinyl alcohol) macrogol grafted copolymer ............... 2945Poly(vinyl chloride) (non-plasticised) for containers for soliddosage forms for oral administration, materials based on(3.1.11.) .................................................................................... 412

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).. 410

Poly(vinyl chloride), plasticised, empty sterile containers of,for human blood and blood components (3.2.4.) ..... 9.6-5866

Poly(vinyl chloride), plasticised, materials based on, forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ........................................................................... 9.6-5852

Poly(vinyl chloride), plasticised, materials based on, forcontainers for human blood and blood components(3.1.1.1.) .......................................................................... 9.6-5843

Poly(vinyl chloride), plasticised, materials based on, fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).................................................... 9.6-5846

Poly(vinyl chloride), plasticised, sterile containers of,for human blood containing anticoagulant solution(3.2.5.) ............................................................................. 9.6-5868

Poppy petals, red..................................................................... 1492Porcine actinobacillosis vaccine (inactivated) .................... 1085Porcine enzootic pneumonia vaccine (inactivated) ........... 1086Porcine influenza vaccine (inactivated) ............................... 1087Porcine insulin ................................................................. 9.3-4931Porcine parvovirosis vaccine (inactivated).......................... 1089Porcine progressive atrophic rhinitis vaccine(inactivated) .......................................................................... 1090

Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) ............................................................. 352

Poria ......................................................................................... 1484Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.).............................................................. 352

Porosity of sintered-glass filters (2.1.2.) ................................... 15Porous solids including powders, wettability of (2.9.45.) .... 381Potassium (2.4.12.) ................................................................... 136Potassium acetate.................................................................... 3375Potassium bromide................................................................. 3376Potassium carbonate............................................................... 3377Potassium chloride ................................................................. 3377Potassium citrate..................................................................... 3378Potassium clavulanate ............................................................ 3378Potassium clavulanate, diluted.............................................. 3381Potassium dichromate for homoeopathic preparations..... 1608Potassium dihydrogen phosphate......................................... 3382Potassium disulfite.................................................................. 3386Potassium hydrogen aspartate hemihydrate ....................... 3383Potassium hydrogen carbonate ............................................. 3384Potassium hydrogen tartrate ................................................. 3384Potassium hydroxide ....................................................... 9.4-5430Potassium iodide..................................................................... 3385Potassium metabisulfite ......................................................... 3386Potassium nitrate .................................................................... 3386Potassium perchlorate ............................................................ 3387Potassium permanganate....................................................... 3388Potassium sodium tartrate tetrahydrate .............................. 3388Potassium sorbate ................................................................... 3389Potassium sulfate ............................................................. 9.6-6185

Potato starch............................................................................ 3390Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 60

Potentiometric determination of pH (2.2.3.) .......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathic stocksand................................................................................... 9.2-4479

Poultices ..................................................................................... 884Pour-on preparations ...................................................... 9.3-4792Povidone ........................................................................... 9.2-4592Povidone, iodinated................................................................ 3394Powdered cellulose ................................................................. 2013Powder fineness (2.9.35.) ................................................ 9.7-6331Powder flow (2.9.36.)................................................................ 362Powders and granules for oral solutions andsuspensions..................................................................... 9.3-4786

Powders and granules for syrups ................................... 9.3-4787Powders and tablets for rectal solutions and suspensions... 882Powders, bulk density and tapped density of (2.9.34.) .. 9.7-6328Powders, ear .............................................................................. 856Powders, effervescent ............................................................... 875Powders for cutaneous application......................................... 874Powders for eye drops and powders for eye lotions ............. 858Powders for injections or infusions........................................ 872Powders for oral drops.................................................... 9.3-4786Powders, inhalation ......................................................... 9.4-5292Powders, nasal ........................................................................... 867Powders, oral ............................................................................. 874Powders, wettability of porous solids including (2.9.45.) .... 381Pramipexole dihydrochloride monohydrate ....................... 3394Pravastatin sodium................................................................. 3396Prazepam ................................................................................. 3397Praziquantel............................................................................. 3398Prazosin hydrochloride.......................................................... 3400Prednicarbate .......................................................................... 3401Prednisolone............................................................................ 3403Prednisolone acetate............................................................... 3404Prednisolone pivalate ............................................................. 3406Prednisolone sodium phosphate........................................... 3407Prednisone........................................................................ 9.3-4980Pregabalin ......................................................................... 9.2-4595Pregelatinised hydroxypropyl starch .................................... 3647Pregelatinised starch............................................................... 3649Prekallikrein activator (2.6.15.)............................................... 208Premixes for medicated feeding stuffs for veterinary use ... 875Preparations for inhalation ............................................ 9.4-5288Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323

Preparations for irrigation....................................................... 880Preparations for nebulisation : characterisation (2.9.44.) .... 378Pressurised pharmaceutical preparations ..................... 9.6-5914Prilocaine.......................................................................... 9.4-5431Prilocaine hydrochloride ................................................ 9.4-5432Primaquine diphosphate................................................. 9.6-6185Primary aromatic amino-nitrogen, determination of(2.5.8.) ...................................................................................... 163

Primary standards for volumetric solutions (4.2.1.) ... 9.7-6465Primidone ......................................................................... 9.3-4982Primula root ............................................................................ 1485Probenecid............................................................................... 3417Procainamide hydrochloride................................................. 3418Procaine benzylpenicillin ............................................... 9.2-4506Procaine hydrochloride.......................................................... 3419Prochlorperazine maleate ...................................................... 3420Products of fermentation................................................ 9.6-5909Products of recombinant DNA technology.................. 9.7-6526Products with risk of transmitting agents of animal spongiformencephalopathies .................................................................... 832

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) .................................................................... 274

Progesterone............................................................................ 3420Progressive atrophic rhinitis vaccine (inactivated),porcine ................................................................................... 1090



Proguanil hydrochloride................................................. 9.7-6669Proline...................................................................................... 3424Promazine hydrochloride ...................................................... 3425Promethazine hydrochloride................................................. 3426Propacetamol hydrochloride................................................. 3427Propafenone hydrochloride................................................... 3428Propanol................................................................................... 3430Propanol and methanol, 2-, test for (2.9.11.) ........................ 318Propantheline bromide .......................................................... 3431Propofol ................................................................................... 3432Propranolol hydrochloride .................................................... 3434Propylene glycol...................................................................... 3437Propylene glycol dicaprylocaprate........................................ 3438Propylene glycol dilaurate .............................................. 9.2-4598Propylene glycol monolaurate............................................... 3439Propylene glycol monopalmitostearate................................ 3440Propylene glycol monostearate ............................................. 3440Propyl gallate........................................................................... 3435Propyl parahydroxybenzoate................................................. 3436Propyl parahydroxybenzoate, sodium ................................. 3599Propylthiouracil ...................................................................... 3441Propyphenazone ..................................................................... 3442Protamine sulfate ............................................................. 9.6-6187Protein assays, host-cell (2.6.34.) ................................... 9.1-4041Protein C, human, assay of (2.7.30.)....................................... 276Protein in polysaccharide vaccines (2.5.16.) ......................... 166Protein S, human, assay of (2.7.31.) ....................................... 277Protein, total (2.5.33.) .............................................................. 172Prothrombin complex, human.............................................. 2695Protirelin.................................................................................. 3444Proxyphylline .......................................................................... 3445Pseudoephedrine hydrochloride........................................... 3446Psyllium seed........................................................................... 1486Pullulan.................................................................................... 3447Pulsed electrochemical detection and direct amperometricdetection (2.2.63.) .......................................................... 9.7-6288

Purified water ................................................................... 9.4-5475Purple coneflower herb.......................................................... 1486Purple coneflower root .......................................................... 1488Pycnometric density of solids, gas (2.9.23.) ................. 9.7-6319Pygeum africanum bark ........................................................ 1490Pyrantel embonate.................................................................. 3448Pyrazinamide .......................................................................... 3449Pyridostigmine bromide ........................................................ 3450Pyridoxine hydrochloride...................................................... 3451Pyrimethamine ................................................................ 9.7-6671Pyrogens (2.6.8.) ....................................................................... 193Pyrophosphate (sodium) decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439

Pyrrolidone.............................................................................. 3453

QQuality control of vaccines, substitution of in vivo method(s)by in vitro method(s) for the (5.2.14.) ........................ 9.3-4737

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.) ............................................................................. 9.7-6473

Quantified hawthorn leaf and flower liquid extract ........... 1387Quetiapine fumarate ....................................................... 9.6-6191Quillaia bark............................................................................ 1491Quinapril hydrochloride........................................................ 3459Quinidine sulfate .................................................................... 3461Quinine hydrochloride .......................................................... 3463Quinine sulfate........................................................................ 3464

RRabbit haemorrhagic disease vaccine (inactivated) ........... 1092Rabeprazole sodium............................................................... 3469Rabeprazole sodium hydrate................................................. 3470Rabies immunoglobulin, human .......................................... 2696Rabies vaccine for human use prepared in cellcultures............................................................................ 9.6-5959

Rabies vaccine (inactivated) for veterinary use .................. 1093Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1096Racecadotril............................................................................. 3472Racementhol............................................................................ 2998Racemic camphor ................................................................... 1934Racemic ephedrine hydrochloride ....................................... 2363Racemic menthol .................................................................... 2998Racephedrine hydrochloride................................................. 2363Raclopride ([11C]methoxy) injection.................................... 1165Radioactivity, detection and measurement of (2.2.66.) ....... 113Radionuclides, table of physical characteristics (5.7.) .. 9.2-4385Radiopharmaceutical preparations ........................................ 832Radiopharmaceutical preparations, chemical precursorsfor ............................................................................................. 813

Radiopharmaceutical preparations, copper tetramibitetrafluoroborate for...................................................... 9.2-4435

Radiopharmaceutical preparations, iobenguane sulfatefor .................................................................................... 9.2-4435

Radiopharmaceutical preparations, medronic acidfor .................................................................................... 9.2-4437

Radiopharmaceutical preparations, pentetate sodium calciumfor .................................................................................... 9.3-4800

Radiopharmaceutical preparations, sodium iodohippuratedihydrate for................................................................... 9.2-4438

Radiopharmaceutical preparations, sodium pyrophosphatedecahydrate for .............................................................. 9.2-4439

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ....................................................................... 9.2-4443

Radiopharmaceuticals, extemporaneous preparation of(5.19.) ....................................................................................... 767

Raloxifene hydrochloride ...................................................... 3473Raltegravir chewable tablets ........................................... 9.5-5743Raltegravir potassium ..................................................... 9.4-5437Raltegravir tablets ............................................................ 9.5-5744Raman spectroscopy (2.2.48.) ................................................... 86Ramipril ................................................................................... 3475Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) ................................................... 273

Ranitidine hydrochloride................................................ 9.6-6197Rapeseed oil, refined .............................................................. 3479Raw materials of biological origin for the production ofcell-based and gene therapymedicinal products (5.2.12.).. 627

Reagents (4.1.1.)............................................................... 9.7-6337Reagents (4.) ..................................................................... 9.7-6337Reagents, standard solutions, buffer solutions (4.1.) .. 9.7-6337Recombinant DNA technology, products of................ 9.7-6526Recombinant vectors ...................................................... 9.7-6497Recommendations on dissolution testing (5.17.1.) .............. 761Recommendations on methods for dosage forms testing(5.17.) ....................................................................................... 761

Rectal capsules .......................................................................... 882Rectal foams .............................................................................. 882Rectal preparations................................................................... 881Rectal preparations, semi-solid............................................... 882Rectal solutions and suspensions, powders and tablets for.. 881Rectal solutions, emulsions and suspensions........................ 882Rectal tampons.......................................................................... 882Red peony root........................................................................ 1471Red poppy petals..................................................................... 1492Reference standards (5.12.) ............................................ 9.5-5563Refractive index (2.2.6.) ............................................................. 26Relative density (2.2.5.) .............................................................. 25Remifentanil hydrochloride ........................................... 9.2-4604Repaglinide.............................................................................. 3479Reserpine ................................................................................. 3481Residual pertussis toxin and irreversibility of pertussis toxoid(2.6.33.) .................................................................................... 235

Residual solvents (5.4.) ................................................... 9.5-5553Residual solvents, identification and control (2.4.24.) ......... 146Residue on evaporation of essential oils (2.8.9.)................... 284Residues, pesticide (2.8.13.)............................................ 9.6-5839Resistance to crushing of tablets (2.9.8.) ............................... 313Resorcinol ................................................................................ 3481



Respiratory syncytial virus vaccine (live), bovine .............. 1022Restharrow root ...................................................................... 1493Retroviridae-derived vectors for human use......................... 746Rhatany root............................................................................ 1494Rhatany tincture ..................................................................... 1495Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1067Rhinotracheitis vaccine (inactivated), viral, feline ............. 1059Rhinotracheitis vaccine (live), bovine, infectious............... 1068Rhinotracheitis vaccine (live), infectious, turkey ............... 1107Rhinotracheitis vaccine (live), viral, feline .......................... 1060Rhubarb ................................................................................... 1496Ribavirin .................................................................................. 3482Riboflavin................................................................................. 3484Riboflavin sodium phosphate ............................................... 3485Ribose in polysaccharide vaccines (2.5.31.) .......................... 171Ribwort plantain ..................................................................... 1497Rice starch ............................................................................... 3487Rifabutin .................................................................................. 3488Rifampicin ............................................................................... 3489Rifamycin sodium............................................................ 9.6-6198Rifaximin ................................................................................. 3492Rilmenidine dihydrogen phosphate ..................................... 3494Risedronate sodium 2.5-hydrate........................................... 3495Risperidone ............................................................................. 3496Ritonavir .................................................................................. 3498Rivastigmine............................................................................ 3501Rivastigmine hydrogen tartrate ............................................ 3503Rizatriptan benzoate .............................................................. 3504Rocuronium bromide............................................................. 3506Rolling ball (automatic) and falling ball viscometer methods(2.2.49.) ........................................................................... 9.3-4690

Roman chamomile flower...................................................... 1313Ropinirole hydrochloride ............................................... 9.6-6200Ropivacaine hydrochloride monohydrate ........................... 3509Roselle ...................................................................................... 1498Rosemary leaf.......................................................................... 1499Rosemary oil ........................................................................... 1500Rosuvastatin calcium.............................................................. 3511Rotating viscometer method - viscosity (2.2.10.) ................... 28Rotation, optical (2.2.7.) ................................................. 9.5-5535Rotavirus diarrhoea vaccine (inactivated), calf .................. 1026Rotavirus vaccine (live, oral)................................................... 978Rotigotine ......................................................................... 9.6-6201Round amomum fruit ............................................................ 1502Roxithromycin ........................................................................ 3513RRR-α-Tocopherol.................................................................. 3801RRR-α-Tocopheryl acetate..................................................... 3804RRR-α-Tocopheryl hydrogen succinate ............................... 3808Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ............................................................................. 9.5-5545

Rubella immunoglobulin, human ........................................ 2698Rubella, measles and mumps vaccine (live) ................. 9.6-5945Rubella, measles, mumps and varicella vaccine (live).. 9.6-5946Rubella vaccine (live) ...................................................... 9.6-5962Ruminant colibacillosis vaccine (inactivated), neonatal.... 1079Rupatadine fumarate ....................................................... 9.3-4987Rutoside trihydrate ................................................................. 3516

SSaccharin........................................................................... 9.7-6675Saccharin sodium ............................................................ 9.7-6676Safety, viral (5.1.7.) ................................................................... 591Safflower flower ...................................................................... 1503Safflower oil, refined............................................................... 3523Saffron for homoeopathic preparations............................... 1599Sage leaf (Salvia officinalis) ................................................... 1505Sage leaf, three-lobed ............................................................. 1506Sage oil, Spanish...................................................................... 1524Sage tincture ............................................................................ 1507Salbutamol ............................................................................... 3523Salbutamol sulfate................................................................... 3526

Salicylic acid ............................................................................ 3528Salmeterol xinafoate ............................................................... 3529Salmonella Enteritidis vaccine (inactivated) for chickens.. 1097Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1098Salmonella Typhimurium vaccine (inactivated) forchickens ................................................................................. 1100

Salmonella Typhimurium vaccine (live, oral) forchickens ................................................................................. 1101

Salmon oil, farmed ................................................................. 3531Salvia miltiorrhiza root and rhizome............................ 9.1-4108Sanguisorba root..................................................................... 1509Saponification value (2.5.6.) .................................................... 163Saquinavir mesilate................................................................. 3533Saw palmetto extract .............................................................. 1509Saw palmetto fruit ........................................................... 9.7-6553Schisandra fruit................................................................ 9.1-4110Scopolamine ............................................................................ 2733Scopolamine butylbromide ............................................ 9.6-6121Scopolamine hydrobromide .................................................. 2735Selamectin for veterinary use................................................ 3535Selegiline hydrochloride ........................................................ 3537Selenium disulfide .................................................................. 3538Selenium for homoeopathic preparations .................... 9.2-4494Selfheal fruit-spike, common ................................................ 1327Semi-micro determination of water (2.5.12.)............... 9.4-5107Semi-solid ear preparations..................................................... 856Semi-solid eye preparations .................................................... 858Semi-solid intrauterine preparations ..................................... 862Semi-solid nasal preparations ................................................. 868Semi-solid oromucosal preparations............................. 9.3-4788Semi-solid preparations for cutaneous application.............. 882Semi-solid preparations for oral use, veterinary .................. 890Semi-solid rectal preparations ................................................ 882Semi-solid vaginal preparations ............................................. 889Senega root .............................................................................. 1515Senna leaf................................................................................. 1516Senna leaf dry extract, standardised .................................... 1517Senna pods, Alexandrian....................................................... 1518Senna pods, Tinnevelly .......................................................... 1519Separation techniques, chromatographic (2.2.46.) ...... 9.2-4286Serine........................................................................................ 3539Sertaconazole nitrate .............................................................. 3540Sertraline hydrochloride................................................. 9.7-6677Sesame oil, refined........................................................... 9.1-4197Sets for the transfusion of blood and blood components(3.2.6.) ...................................................................................... 433

Sevoflurane ....................................................................... 9.5-5749Shampoos .................................................................................. 864Shellac ..................................................................................... 3547Shingles (herpes zoster) vaccine (live) .......................... 9.6-5963Sialic acid in polysaccharide vaccines (2.5.23.)..................... 168Siam benzoin........................................................................... 1272Siam benzoin tincture ............................................................ 1274Sieves (2.1.4.)............................................................................... 16Sieve test (2.9.12.) ..................................................................... 319Sieving, analytical, particle-size distribution estimation by(2.9.38.) .................................................................................... 367

SI (International System) units (1.) ............................... 9.2-4275Sildenafil citrate ............................................................... 9.2-4611Silica, colloidal anhydrous..................................................... 3549Silica, colloidal hydrated........................................................ 3550Silica, dental type.................................................................... 3550Silica, hydrophobic colloidal ................................................. 3551Silicate, aluminium magnesium..................................... 9.3-4839Silicate, aluminium sodium................................................... 1686Silicone elastomer for closures and tubing (3.1.9.)............... 409Silicone oil used as a lubricant (3.1.8.)................................... 408Silk suture, sterile, braided, in distributor for veterinary use................................................................................................ 1221

Silver, colloidal, for external use........................................... 3552Silver nitrate ............................................................................ 3552Simeticone ............................................................................... 3553Simvastatin .......................................................................9.7-6679



Single-dose preparations, uniformity of content (2.9.6.)..... 312Single-dose preparations, uniformity of mass (2.9.5.) ......... 311Sintered-glass filters (2.1.2.) ...................................................... 15Sitagliptin phosphate monohydrate .............................. 9.1-4198Sitagliptin tablets .................................................................... 3557Size-exclusion chromatography (2.2.30.)...................... 9.6-5823(S)-Lactic acid ......................................................................... 2861Smallpox vaccine (live) ................................................... 9.6-5964Sodium acetate ([1-11C]) injection........................................ 1166Sodium acetate trihydrate...................................................... 3558Sodium alendronate trihydrate ............................................. 3559Sodium alginate ...................................................................... 3560Sodium aluminium silicate.................................................... 1686Sodium amidotrizoate............................................................ 3561Sodium aminosalicylate dihydrate ....................................... 3562Sodium ascorbate ................................................................... 3563Sodium aurothiomalate ......................................................... 3565Sodium benzoate .................................................................... 3566Sodium bromide ..................................................................... 3567Sodium calcium edetate......................................................... 3568Sodium calcium pentetate for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Sodium caprylate .................................................................... 3569Sodium carbonate................................................................... 3570Sodium carbonate decahydrate............................................. 3570Sodium carbonate monohydrate .......................................... 3571Sodium carboxymethylcellulose ........................................... 1958Sodium carboxymethylcellulose, cross-linked.................... 2174Sodium carboxymethylcellulose, low-substituted .............. 1958Sodium cetostearyl sulfate.............................................. 9.4-5443Sodium chloride...................................................................... 3573Sodium chromate (51Cr) sterile solution.............................. 1167Sodium citrate ......................................................................... 3574Sodium cromoglicate ............................................................. 3574Sodium cyclamate................................................................... 3576Sodium dihydrogen phosphate dihydrate ........................... 3577Sodium disulfite ...................................................................... 3591Sodium ethyl parahydroxybenzoate..................................... 3577Sodium fluoride ...................................................................... 3579Sodium fluoride (18F) injection............................................. 1168Sodium fusidate ...................................................................... 3579Sodium glycerophosphate, hydrated .................................... 3582Sodium hyaluronate ............................................................... 3583Sodium hydrogen carbonate ................................................. 3585Sodium hydroxide .................................................................. 3585Sodium iodide......................................................................... 3586Sodium iodide (123I) injection ............................................... 1169Sodium iodide (123I) solution for radiolabelling ................. 1170Sodium iodide (131I) capsules for diagnostic use ................ 1170Sodium iodide (131I) capsules for therapeutic use .............. 1171Sodium iodide (131I) solution ................................................ 1172Sodium iodide (131I) solution for radiolabelling ................. 1173Sodium iodohippurate (123I) injection ................................. 1175Sodium iodohippurate (131I) injection ................................. 1176Sodium iodohippurate dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438

Sodium lactate solution ......................................................... 3586Sodium laurilsulfate ........................................................ 9.1-4200Sodium lauroylsarcosinate for external use......................... 3589Sodium metabisulfite ............................................................. 3591Sodium methyl parahydroxybenzoate ................................. 3591Sodium molybdate (99Mo) solution (fission) ...................... 1176Sodium molybdate dihydrate ......................................... 9.7-6682Sodium nitrite ......................................................................... 3593Sodium nitroprusside............................................................. 3593Sodium perborate, hydrated.................................................. 3594Sodium pertechnetate (99mTc) injection (accelerator-produced) ....................................................................... 9.3-4801

Sodium pertechnetate (99mTc) injection (fission) ............... 1178Sodium pertechnetate (99mTc) injection (non-fission) ....... 1180Sodium phenylbutyrate.......................................................... 3595Sodium phosphate (32P) injection......................................... 1180Sodium picosulfate ................................................................. 3596

Sodium polystyrene sulfonate ............................................... 3597Sodium propionate ................................................................. 3598Sodium propyl parahydroxybenzoate .................................. 3599Sodium pyrophosphate decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439

Sodium risedronate 2.5-hydrate ........................................... 3495Sodium salicylate .................................................................... 3601Sodium selenite....................................................................... 3601Sodium selenite pentahydrate ............................................... 3602Sodium (S)-lactate solution................................................... 3587Sodium starch glycolate (type A)................................... 9.1-4200Sodium starch glycolate (type B) ................................... 9.1-4202Sodium starch glycolate (type C).......................................... 3604Sodium stearate....................................................................... 3605Sodium stearyl fumarate........................................................ 3606Sodium sulfate, anhydrous ............................................. 9.6-6207Sodium sulfate decahydrate............................................ 9.6-6207Sodium sulfite ......................................................................... 3608Sodium sulfite heptahydrate.................................................. 3608Sodium tetrachloroaurate dihydrate for homoeopathicpreparations ................................................................... 9.5-5623

Sodium thiosulfate.................................................................. 3609Sodium valproate.................................................................... 3609Soft capsules ..................................................................... 9.4-5287Softening time determination of lipophilic suppositories(2.9.22.) .................................................................................... 338

Soft extracts ...................................................................... 9.7-6521Solid dosage forms, dissolution test for (2.9.3.).................... 302Solid dosage forms, recommendations on dissolution testingof (5.17.1.)................................................................................ 761

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.) .......................................................... 352

Solids, density of (2.2.42.).......................................................... 70Solids, gas pycnometric density of (2.9.23.) ................. 9.7-6319Solids (porous) including powders, wettability of (2.9.45.).. 381Solifenacin succinate ....................................................... 9.3-4991Solubility in alcohol of essential oils (2.8.10.) ....................... 284Soluble tablets .................................................................. 9.3-4792Solution calorimetry and microcalorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109

Solutions, emulsions and suspensions, oral ................. 9.3-4786Solutions for haemodialysis............................................ 9.6-6115Solutions for haemodialysis, concentrated, water fordiluting................................................................................... 2627

Solutions for haemofiltration and haemodiafiltration ........ 9.6-6119

Solutions for organ preservation .......................................... 3612Solutions for peritoneal dialysis..................................... 9.6-6175Solutions, suspensions, intrauterine....................................... 862Solvents, residual (5.4.) ................................................... 9.5-5553Solvents, residual, identification and control (2.4.24.)......... 146Somatostatin............................................................................ 3613Somatropin ....................................................................... 9.5-5750Somatropin concentrated solution ................................ 9.5-5752Somatropin for injection ................................................ 9.5-5754Somatropin solution for injection ........................................ 3620Sophora flower ........................................................................ 1520Sophora flower-bud................................................................ 1522Sorbic acid ............................................................................... 3622Sorbitan laurate................................................................ 9.1-4203Sorbitan oleate.................................................................. 9.1-4203Sorbitan palmitate ........................................................... 9.1-4204Sorbitan sesquioleate....................................................... 9.1-4205Sorbitan stearate .............................................................. 9.1-4205Sorbitan trioleate ............................................................. 9.1-4206Sorbitol..................................................................................... 3625Sorbitol, liquid (crystallising) ............................................... 3626Sorbitol, liquid (non-crystallising) ....................................... 3627Sorbitol, liquid, partially dehydrated ................................... 3628Sorption-desorption isotherms and water activity,determination of (water-solid interactions) (2.9.39.)........ 9.7-6331

Sotalol hydrochloride............................................................. 3629



Soya-bean oil, hydrogenated ................................................. 3630Soya-bean oil, refined...................................................... 9.3-4992Soya phospholipids for injection ................................... 9.4-5445Spanish sage oil ....................................................................... 1524Specific surface area by air permeability (2.9.14.) ....... 9.1-4053Specific surface area by gas adsorption (2.9.26.) .................. 344Spectinomycin dihydrochloride pentahydrate.................... 3631Spectinomycin sulfate tetrahydrate for veterinary use ...... 3633Spectrometry, atomic absorption (2.2.23.) .............................. 37Spectrometry, atomic emission (2.2.22.) ................................. 36Spectrometry, mass (2.2.43.) ..................................................... 71Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 54Spectrometry, X-ray fluorescence (2.2.37.) .................. 9.3-4689Spectrophotometry, infrared absorption (2.2.24.) ...... 9.7-6285Spectrophotometry, ultraviolet and visible absorption(2.2.25.) ...................................................................................... 41

Spectroscopy, near-infrared (2.2.40.) ....................................... 64Spectroscopy, Raman (2.2.48.).................................................. 86SPF chicken flocks for the production and quality control ofvaccines (5.2.2.)....................................................................... 599

Spheroids and granules, friability of (2.9.41.) ....................... 375Spike lavender oil............................................................. 9.5-5617Spiramycin........................................................................ 9.2-4612Spirapril hydrochloride monohydrate ................................. 3638Spironolactone ........................................................................ 3639Spot-on preparations....................................................... 9.3-4793Sprays (liquid nasal) and drops (nasal).................................. 867Sprays, veterinary ............................................................ 9.3-4793Squalane................................................................................... 3641Standard solutions for limit tests (4.1.2.)...................... 9.7-6454Standards, reference (5.12.) ............................................ 9.5-5563Stannous chloride dihydrate.................................................. 3644Stanozolol ................................................................................ 3644Staphysagria for homoeopathic preparations ..................... 1612Star anise.................................................................................. 1529Star anise oil ............................................................................ 1530Starches, hydroxyethyl .................................................... 9.6-6208Starch glycolate (type A), sodium.................................. 9.1-4200Starch glycolate (type B), sodium.................................. 9.1-4202Starch glycolate (type C), sodium......................................... 3604Starch, hydroxypropyl ............................................................ 3645Starch, hydroxypropyl, pregelatinised.................................. 3647Starch, maize ........................................................................... 2969Starch, pea ............................................................................... 3277Starch, potato .......................................................................... 3390Starch, pregelatinised ............................................................. 3649Starch, rice ............................................................................... 3487Starch, wheat ........................................................................... 3937Starflower (borage) oil, refined ............................................. 1858Statistical analysis of results of biological assays and tests(5.3.) ................................................................................ 9.2-4353

Stavudine ................................................................................. 3653Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.) ................................................................... 580

Stearic acid............................................................................... 3655Stearoyl macrogolglycerides ........................................... 9.1-4206Stearyl alcohol ......................................................................... 3657Stem cells, human haematopoietic ................................ 9.7-6627Stephania root, fourstamen ................................................... 1357Sterile braided silk suture in distributor for veterinaryuse........................................................................................... 1221

Sterile catgut ............................................................................ 1207Sterile catgut in distributor for veterinary use.................... 1219Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ...... 9.6-5868

Sterile linen thread in distributor for veterinary use ......... 1220Sterile non-absorbable strands in distributor for veterinaryuse........................................................................................... 1222

Sterile non-absorbable sutures ....................................... 9.5-5603Sterile plastic containers for human blood and bloodcomponents (3.2.3.)....................................................... 9.6-5865

Sterile polyamide 6/6 suture in distributor for veterinaryuse.................................................................................... 9.5-5609

Sterile polyamide 6 suture in distributor for veterinaryuse.................................................................................... 9.5-5609

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use................................................................. 9.5-5609

Sterile products, biological indicators and related microbialpreparations used in the manufacture of (5.1.2.) ...... 9.2-4336

Sterile products, methods of preparation of (5.1.1.) ... 9.2-4333Sterile single-use plastic syringes (3.2.8.) .............................. 434Sterile synthetic absorbable braided sutures ....................... 1212Sterile synthetic absorbable monofilament sutures ............ 1213Sterility (2.6.1.).......................................................................... 185Sterility, guidelines for using the test for (5.1.9.).................. 592Sterols in fatty oils (2.4.23.) ..................................................... 144Sticks ................................................................................. 9.6-5914Sticks, intrauterine.................................................................... 862Sticks, nasal ............................................................................... 868St. John’s wort.......................................................................... 1526St. John’s wort dry extract, quantified.................................. 1527Stomata and stomatal index (2.8.3.) ....................................... 283Stramonium leaf .............................................................. 9.2-4473Stramonium, prepared .................................................... 9.2-4475Strands, sterile non-absorbable, in distributor for veterinaryuse .......................................................................................... 1222

Streptokinase concentrated solution ............................. 9.6-6212Streptomycin sulfate ........................................................ 9.6-6213Strontium (89Sr) chloride injection....................................... 1181Strychnos ignatii for homoeopathic preparations ....... 9.3-4827Subdivision of tablets ...................................................... 9.3-4790Sublingual sprays, oromucosal drops and oromucosalsprays............................................................................... 9.3-4787

Sublingual tablets and buccal tablets............................. 9.3-4789Substances for pharmaceutical use................................ 9.3-4777Substances for pharmaceutical use, control of impurities in(5.10.) ....................................................................................... 723

Substances of animal origin for the production ofimmunological veterinary medicinal products (5.2.5.) ..... 608

Substitution of in vivo method(s) by in vitro method(s) for thequality control of vaccines (5.2.14.) ............................ 9.3-4737

Sub-visible particles, particulate contamination (2.9.19.) ... 335Sucralfate .......................................................................... 9.4-5447Sucralose ........................................................................... 9.2-4615Sucrose ..................................................................................... 3664Sucrose, liquid.................................................................. 9.4-5448Sucrose monopalmitate.......................................................... 3665Sucrose stearate....................................................................... 3666Sufentanil ................................................................................. 3668Sufentanil citrate ..................................................................... 3669Sugars, lead in (2.4.10.) ............................................................ 136Sugar spheres........................................................................... 3670Sulbactam sodium .................................................................. 3671Sulfacetamide sodium............................................................ 3673Sulfadiazine ............................................................................. 3674Sulfadimethoxine............................................................. 9.4-5450Sulfadimethoxine sodium for veterinary use ............... 9.4-5451Sulfadimidine .......................................................................... 3678Sulfadoxine .............................................................................. 3680Sulfafurazole............................................................................ 3681Sulfaguanidine ........................................................................ 3681Sulfamerazine.......................................................................... 3682Sulfamethizole......................................................................... 3683Sulfamethoxazole.................................................................... 3684Sulfamethoxypyridazine for veterinary use......................... 3685Sulfanilamide........................................................................... 3686Sulfasalazine .....................................................................9.2-4617Sulfated ash (2.4.14.) ................................................................ 136Sulfates (2.4.13.)........................................................................ 136Sulfathiazole ............................................................................ 3689Sulfinpyrazone......................................................................... 3689Sulfobutylbetadex sodium .............................................. 9.6-6215Sulfur dioxide (2.5.29.)............................................................. 171Sulfur for external use............................................................ 3691Sulfur for homoeopathic preparations................................. 1614Sulfuric acid............................................................................. 3691



Sulindac.................................................................................... 3692Sulpiride................................................................................... 3693Sultamicillin ............................................................................ 3694Sultamicillin tosilate dihydrate ............................................. 3697Sumatra benzoin..................................................................... 1273Sumatra benzoin tincture ...................................................... 1274Sumatriptan succinate............................................................ 3699Sunflower oil, refined ............................................................. 3701Supercritical fluid chromatography (2.2.45.) .......................... 74Suppositories ............................................................................. 881Suppositories and pessaries, disintegration of (2.9.2.) ......... 301Suppositories, lipophilic, softening time determination(2.9.22.) .................................................................................... 338

Suspensions, solutions and emulsions, oral ................. 9.3-4786Suspensions, solutions, intrauterine....................................... 862Sutures, sterile non-absorbable ...................................... 9.5-5603Sutures, sterile synthetic absorbable braided ..................... 1212Sutures, sterile synthetic absorbable monofilament .......... 1213Suxamethonium chloride ...................................................... 3701Suxibuzone .............................................................................. 3702Sweet fennel............................................................................. 1353Sweet orange oil ...................................................................... 1535Swelling index (2.8.4.) .............................................................. 284Swine erysipelas vaccine (inactivated) ................................. 1104Swine-fever vaccine (live, prepared in cell cultures),classical .................................................................................. 1104

Symbols and abbreviations (1.) ...................................... 9.2-4275Synthetic absorbable braided sutures, sterile ...................... 1212Synthetic absorbable monofilament sutures, sterile ........... 1213Syringes, plastic, sterile single-use (3.2.8.) ............................ 434Syrups................................................................................ 9.3-4787Szechwan lovage rhizome ............................................... 9.4-5314

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.)............................ 9.2-4385

Tablets ............................................................................... 9.3-4790Tablets and capsules, disintegration of (2.9.1.) ..................... 299Tablets and powders for rectal solutions and suspensions .. 882Tablets, buccal .................................................................. 9.3-4789Tablets, chewable ............................................................. 9.3-4792Tablets, coated.................................................................. 9.3-4791Tablets, dispersible........................................................... 9.3-4792Tablets, effervescent......................................................... 9.3-4791Tablets for intrauterine solutions and suspensions .............. 862Tablets for use in the mouth.................................................... 887Tablets for vaginal solutions and suspensions ...................... 889Tablets, gastro-resistant................................................... 9.3-4791Tablets, intrauterine.................................................................. 862Tablets, modified-release ................................................ 9.3-4791Tablets, orodispersible..................................................... 9.3-4792Tablets, resistance to crushing (2.9.8.) ................................... 313Tablets, soluble ................................................................. 9.3-4792Tablets, subdivision of..................................................... 9.3-4790Tablets, sublingual ........................................................... 9.3-4789Tablets, uncoated ............................................................. 9.3-4791Tablets, uncoated, friability of (2.9.7.) ................................... 312Tablets, vaginal.......................................................................... 888Tacalcitol monohydrate.......................................................... 3707Tacrolimus monohydrate................................................ 9.3-4997Tadalafil.................................................................................... 3708Talc ........................................................................................... 3710Tamoxifen citrate .................................................................... 3712Tampons, ear ............................................................................. 856Tampons, medicated ............................................................... 887Tampons, rectal......................................................................... 882Tampons, vaginal, medicated.................................................. 889Tamsulosin hydrochloride..................................................... 3714Tannic acid .............................................................................. 3716Tannins in herbal drugs (2.8.14.)............................................ 288Tapped density and bulk density of powders (2.9.34.) .. 9.7-6328Tartaric acid............................................................................. 3716

Teat dips ............................................................................ 9.3-4793Tea tree oil ............................................................................... 1536Teat sprays ........................................................................ 9.3-4793Technetium (99mTc) bicisate injection ........................... 9.2-4440Technetium (99mTc) colloidal rhenium sulfide injection ... 1183Technetium (99mTc) colloidal sulfur injection ..................... 1184Technetium (99mTc) colloidal tin injection .......................... 1185Technetium (99mTc) etifenin injection.................................. 1185Technetium (99mTc) exametazime injection ........................ 1187Technetium (99mTc) gluconate injection .............................. 1188Technetium (99mTc) human albumin injection ................... 1189Technetium (99mTc) macrosalb injection ............................. 1190Technetium (99mTc) mebrofenin injection .................... 9.2-4440Technetium (99mTc) medronate injection ............................ 1192Technetium (99mTc) mertiatide injection ............................. 1193Technetium (99mTc) microspheres injection ........................ 1194Technetium (99mTc) oxidronate injection ............................ 1195Technetium (99mTc) pentetate injection ............................... 1196Technetium (99mTc) sestamibi injection........................ 9.2-4441Technetium (99mTc) succimer injection................................ 1199Technetium (99mTc) tin pyrophosphate injection ............... 1199Teicoplanin .............................................................................. 3717Telmisartan....................................................................... 9.7-6685Temazepam.............................................................................. 3720Temozolomide.................................................................. 9.7-6686Tenosynovitis vaccine (live), viral, avian ............................. 1017Tenoxicam ........................................................................ 9.4-5456Terazosin hydrochloride dihydrate ...................................... 3724Terbinafine hydrochloride ..................................................... 3727Terbutaline sulfate .................................................................. 3728Terconazole.............................................................................. 3729Terfenadine.............................................................................. 3730Teriparatide ............................................................................. 3732Terlipressin ....................................................................... 9.2-4623Terminology used in monographs on biological products(5.2.1.) ...................................................................................... 599

Terpin monohydrate........................................................ 9.7-6688Test for anticomplementary activity of immunoglobulin(2.6.17.) ........................................................................... 9.3-4713

Test for anti-D antibodies in human immunoglobulin(2.6.26.) .................................................................................... 225

Test for aristolochic acids in herbal drugs (2.8.21) .............. 292Test for extractable volume of parenteral preparations(2.9.17.) .................................................................................... 322

Test for Fc function of immunoglobulin (2.7.9.) ......... 9.3-4724Test for methanol and 2-propanol (2.9.11.) .......................... 318Test for neurovirulence of live virus vaccines (2.6.18.)........ 212Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) ................... 199

Testosterone............................................................................. 3734Testosterone decanoate .......................................................... 3736Testosterone enantate ............................................................. 3738Testosterone isocaproate ........................................................ 3740Testosterone propionate......................................................... 3741Tests for extraneous agents in viral vaccines for human use(2.6.16.) ........................................................................... 9.4-5111

Tests for specified micro-organisms (microbiologicalexamination of live biotherapeutic products)(2.6.38.) ........................................................................... 9.7-6301

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273

Tetanus and diphtheria vaccine (adsorbed) .......................... 899Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900

Tetanus antitoxin for human use .......................................... 1119Tetanus antitoxin for veterinary use..................................... 1123Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903



Tetanus, diphtheria and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ... 9.6-5920

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ... 9.5-5585

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ........................................................ 9.5-5587

Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Tetanus, diphtheria, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ...................................................................... 9.5-5590

Tetanus immunoglobulin, human ........................................ 2698Tetanus vaccine (adsorbed) ..................................................... 987Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 253Tetanus vaccine for veterinary use ....................................... 1106Tetracaine hydrochloride....................................................... 3742Tetracosactide.......................................................................... 3743Tetracycline ............................................................................. 3744Tetracycline hydrochloride.................................................... 3746Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations ................................................................... 9.2-4443

Tetrazepam .............................................................................. 3747Tetryzoline hydrochloride ..................................................... 3749Thallous (201Tl) chloride injection ........................................ 1202Theobromine........................................................................... 3749Theophylline ........................................................................... 3750Theophylline-ethylenediamine ............................................. 3752Theophylline-ethylenediamine hydrate ............................... 3754Theophylline monohydrate ................................................... 3751Thermal analysis (2.2.34.).......................................................... 57Thermogravimetry (2.2.34.) ...................................................... 57Thiamazole .............................................................................. 3755Thiamine hydrochloride ........................................................ 3756Thiamine nitrate ..................................................................... 3758Thiamphenicol ........................................................................ 3760Thin-layer chromatography (2.2.27.) ....................................... 43Thiocolchicoside crystallised from ethanol ................. 9.3-4999Thiocolchicoside hydrate................................................ 9.3-5002Thioctic acid............................................................................ 3765Thiomersal............................................................................... 3766Thiopental sodium and sodium carbonate ......................... 3767Thioridazine ............................................................................ 3768Thioridazine hydrochloride .................................................. 3770Thomson kudzuvine root ............................................... 9.7-6555Three-lobed sage leaf ............................................................. 1506Threonine ................................................................................ 3771Thyme ...................................................................................... 1538Thyme oil, thymol type.......................................................... 1540Thyme, wild............................................................................. 1559Thymol..................................................................................... 3772Thymol type thyme oil........................................................... 1540Tiabendazole ........................................................................... 3773Tiamulin for veterinary use................................................... 3774Tiamulin hydrogen fumarate for veterinary use................. 3777Tianeptine sodium.................................................................. 3779Tiapride hydrochloride .......................................................... 3781Tiaprofenic acid ...................................................................... 3782Tibolone................................................................................... 3783Ticarcillin sodium .................................................................. 3784Tick-borne encephalitis vaccine (inactivated) ............. 9.6-5968

Ticlopidine hydrochloride ..................................................... 3786Tigecycline........................................................................9.6-6221Tilidine hydrochloride hemihydrate .................................... 3788Timolol maleate ...................................................................... 3789Tinctures ........................................................................... 9.7-6520Tinidazole ................................................................................ 3791Tinnevelly senna pods............................................................ 1519Tinzaparin sodium ................................................................. 3792Tioconazole ............................................................................. 3793Tiotropium bromide monohydrate ............................... 9.3-5004Titanium dioxide .................................................................... 3796Titration, amperometric (2.2.19.) ............................................. 35Titration, potentiometric (2.2.20.)............................................ 35Titrations, complexometric (2.5.11.)...................................... 164Titration, voltametric (2.2.65.)................................................ 112Tizanidine hydrochloride ...................................................... 3797Tobramycin.............................................................................. 3799Tocopherol, all-rac-α-............................................................. 3800Tocopherol, RRR-α-................................................................ 3801Tocopheryl acetate, all-rac-α- ............................................... 3802α-Tocopheryl acetate concentrate (powder form).............. 3805Tocopheryl acetate, RRR-α-................................................... 3804Tocopheryl hydrogen succinate, DL-α- ................................ 3806Tocopheryl hydrogen succinate, RRR-α- ............................. 3808Tolbutamide............................................................................. 3810Tolfenamic acid ....................................................................... 3811Tolnaftate ................................................................................. 3812Tolterodine tartrate................................................................. 3813Tolu balsam ............................................................................. 1541Toluenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.40.)................................................................. 179

Torasemide .............................................................................. 3815Tormentil ................................................................................. 1542Tormentil tincture .................................................................. 1542Tosylchloramide sodium ....................................................... 3816Total ash (2.4.16.)...................................................................... 137Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 157Total organic carbon in water for pharmaceutical use(2.2.44.) ...................................................................................... 73

Total protein (2.5.33.)............................................................... 172Traditional Chinese medicine, names of herbal drugs used in(5.22.) .............................................................................. 9.7-6511

Tragacanth ............................................................................... 1543Tramadol hydrochloride ........................................................ 3817Tramazoline hydrochloride monohydrate........................... 3818Trandolapril............................................................................. 3819Tranexamic acid...................................................................... 3821Transdermal patches ................................................................ 873Transdermal patches, dissolution test for (2.9.4.)................. 309Trapidil..................................................................................... 3822Trehalose dihydrate ................................................................ 3823Tretinoin .................................................................................. 3824Triacetin ................................................................................... 3825Triamcinolone ......................................................................... 3826Triamcinolone acetonide ....................................................... 3827Triamcinolone hexacetonide ................................................. 3829Triamterene ............................................................................. 3830Tribenoside.............................................................................. 3832Tributyl acetylcitrate............................................................... 3833Trichloroacetic acid ................................................................ 3835Triclabendazole for veterinary use ....................................... 3836Triethanolamine...................................................................... 3849Triethyl citrate ......................................................................... 3837Trifluoperazine hydrochloride .............................................. 3837Triflusal .................................................................................... 3838Triglycerides, medium-chain ................................................ 3839Triglycerides, omega-3-acid .................................................. 3209Triglycerol diisostearate ......................................................... 3841Trihexyphenidyl hydrochloride ............................................ 3841Trimebutine maleate ....................................................... 9.3-5005Trimeprazine hemitartrate .................................................... 1666Trimetazidine dihydrochloride ............................................. 3843Trimethadione......................................................................... 3845



Trimethoprim.......................................................................... 3846Trimipramine maleate............................................................ 3848Tri-n-butyl phosphate ............................................................ 3834Tritiated (3H) water injection ................................................ 1202Trolamine................................................................................. 3849Trometamol ............................................................................. 3851Tropicamide............................................................................. 3852Tropisetron hydrochloride..................................................... 3853Trospium chloride .................................................................. 3855Troxerutin......................................................................... 9.3-5007Trypsin ..................................................................................... 3857Tryptophan .............................................................................. 3858TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ......................... 613

TSE, animal, products with risk of transmitting agents of.. 832Tuberculin for human use, old.............................................. 3861Tuberculin purified protein derivative, avian ..................... 3862Tuberculin purified protein derivative, bovine ................... 3863Tuberculin purified protein derivative for human use....... 3864Tuberculosis (BCG) vaccine, freeze-dried............................. 895Tubes for comparative tests (2.1.5.).......................................... 17Tubing and closures, silicone elastomer for (3.1.9.) ............. 409Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ................................................... 9.6-5846

Turkey infectious rhinotracheitis vaccine (live) ................. 1107Turmeric, Javanese.................................................................. 1544Turmeric rhizome................................................................... 1545Turpentine oil................................................................... 9.4-5316Tylosin for veterinary use ............................................... 9.3-5008Tylosin phosphate bulk solution for veterinary use .... 9.3-5012Tylosin phosphate for veterinary use ............................ 9.3-5017Tylosin tartrate for veterinary use ................................. 9.3-5021Typhae pollen................................................................... 9.7-6556Typhoid polysaccharide and hepatitis A (inactivated,adsorbed) vaccine ..........................................................9.6-5924

Typhoid polysaccharide vaccine .................................... 9.6-5970Typhoid vaccine ............................................................... 9.6-5972Typhoid vaccine (live, oral, strain Ty 21a) ............................ 992Tyrosine ................................................................................... 3870Tyrothricin............................................................................... 3871

UUbidecarenone ........................................................................ 3875Udder-washes................................................................... 9.3-4793Ultraviolet and visible absorption spectrophotometry(2.2.25.) ...................................................................................... 41

Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15Uncaria stem with hooks ................................................ 9.3-4821Uncoated tablets .............................................................. 9.3-4791Undecylenic acid..................................................................... 3876Uniformity of content of single-dose preparations (2.9.6.).. 312Uniformity of dosage units (2.9.40.) ............................. 9.1-4055Uniformity of dosage units, demonstration using large samplesizes (2.9.47.) ........................................................................... 384

Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) ................................................................. 347

Uniformity of mass of single-dose preparations (2.9.5.) ..... 311Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ................................................................................... 9.2-4275

Unsaponifiable matter (2.5.7.)................................................. 163Urea .......................................................................................... 3877Urofollitropin ................................................................... 9.4-5463Urokinase.......................................................................... 9.4-5464Uronic acids in polysaccharide vaccines (2.5.22.) ................ 168Ursodeoxycholic acid ............................................................ 3880Urtica dioica for homoeopathic preparations..................... 1614

VVaccine component assay by immunonephelometry(2.7.35.) .................................................................................... 279

Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 165Vaccines, adsorbed, calcium in (2.5.14.)................................ 166Vaccines and immunosera, phenol in (2.5.15.)..................... 166Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610

Vaccines for human use .................................................. 9.5-5571Vaccines for human use, cell substrates for the production of(5.2.3.) ............................................................................. 9.3-4733

Vaccines for human use, conjugated polysaccharide, carrierproteins for the production of (5.2.11.) ............................... 626

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) ........................................................................... 9.4-5111

Vaccines for veterinary use............................................. 9.5-5574Vaccines for veterinary use, inactivated, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630

Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 167Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 167Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 166Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 167Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 166Vaccines, polysaccharide, protein in (2.5.16.) ....................... 166Vaccines, polysaccharide, ribose in (2.5.31.)......................... 171Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 168Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 168Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ................................................................... 599

Vaccines, substitution of in vivo method(s) by in vitromethod(s) for the quality control of (5.2.14.) ............ 9.3-4737

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ...................................................................................... 606

Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 212Vaginal capsules ........................................................................ 888Vaginal foams............................................................................ 889Vaginal preparations ................................................................ 887Vaginal preparations, semi-solid ............................................ 889Vaginal solutions and suspensions, tablets for...................... 889Vaginal solutions, emulsions and suspensions...................... 888Vaginal tablets ........................................................................... 888Vaginal tampons, medicated ................................................... 889Valaciclovir hydrochloride ............................................. 9.3-5029Valaciclovir hydrochloride, hydrated ............................ 9.3-5032Valerian dry aqueous extract ............................................... 1549Valerian dry hydroalcoholic extract ..................................... 1550Valerian root..................................................................... 9.1-4111Valerian root, cut ............................................................. 9.1-4113Valerian tincture ..................................................................... 1554Validation of nucleic acid amplification techniques for thedetection of B19 virus (B19V) DNA in plasma pools :guidelines................................................................................. 214

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines................................................................................. 214

Valine ....................................................................................... 3890Valnemulin hydrochloride for veterinary use .................... 3892Valproate, sodium................................................................... 3609Valproic acid............................................................................ 3893Valsartan .................................................................................. 3895Vancomycin hydrochloride ................................................... 3896Vanillin..................................................................................... 3898Vapour, preparations to be converted into................... 9.4-5289Vardenafil hydrochloride trihydrate..................................... 3898Varicella immunoglobulin for intravenous administration,human .................................................................................... 2700

Varicella immunoglobulin, human ...................................... 2700Varicella, measles, mumps and rubella vaccine (live).. 9.6-5946Varicella vaccine (live) .................................................... 9.6-5972Vectors for human use, adeno-associated-virus .......... 9.7-6506



Vectors for human use, adenovirus ............................... 9.7-6500Vectors for human use, plasmid .................................... 9.7-6498Vectors for human use, plasmid, bacterial cells used for themanufacture of............................................................... 9.7-6499

Vectors for human use, poxvirus ................................... 9.7-6502Vectors for human use, retroviridae-derived ............... 9.7-6504Vecuronium bromide ...................................................... 9.1-4211Vedaprofen for veterinary use............................................... 3901Vegetable fatty oils .................................................................... 848Venlafaxine hydrochloride .................................................... 3902Verapamil hydrochloride ....................................................... 3904Verbena herb ........................................................................... 1555Veterinary liquid preparations for cutaneousapplication ...................................................................... 9.3-4792

Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.)........................ 608

Veterinary semi-solid preparations for oral use ................... 890Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.) ...................................................................................... 612

Viability, nucleated cell count and (2.7.29.) .......................... 275Vibriosis (cold-water) vaccine (inactivated) forsalmonids........................................................................ 9.2-4428

Vibriosis vaccine (inactivated) for salmonids .............. 9.2-4429VICH (5.8.)....................................................................... 9.7-6477Vigabatrin ................................................................................ 3906Vinblastine sulfate .................................................................. 3907Vincristine sulfate ................................................................... 3908Vindesine sulfate.............................................................. 9.3-5034Vinorelbine tartrate ......................................................... 9.4-5469Vinpocetine ............................................................................. 3914Viper venom antiserum, European ...................................... 1119Viral diarrhoea vaccine (inactivated), bovine ..................... 1023Viral hepatitis type I vaccine (live), duck ............................ 1047Viral rhinotracheitis vaccine (inactivated), feline .............. 1059Viral rhinotracheitis vaccine (live), feline ........................... 1060Viral safety (5.1.7.).................................................................... 591Viral tenosynovitis vaccine (live), avian .............................. 1017Viral vaccines for human use, tests for extraneous agents in(2.6.16.) ........................................................................... 9.4-5111

Viscometer method, capillary (2.2.9.) ...........................9.6-5819Viscometer methods, falling ball and automatic rolling ball(2.2.49.) ........................................................................... 9.3-4690

Viscose wadding, absorbent .................................................. 3915Viscosity (2.2.8.)............................................................... 9.4-5099Viscosity - rotating viscometer method (2.2.10.) ................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) ...................................................................................... 41

Visible particles, particulate contamination (2.9.20.) .......... 337Vitamin A ................................................................................ 3917Vitamin A concentrate (oily form), synthetic .............. 9.3-5036Vitamin A concentrate (powder form), synthetic ....... 9.3-5037Vitamin A concentrate (solubilisate/emulsion),synthetic.......................................................................... 9.3-5038

Voltametric titration (2.2.65.) ................................................. 112Volumetric analysis (4.2.) ............................................... 9.7-6465Volumetric solutions (4.2.2.) .......................................... 9.7-6465Volumetric solutions, primary standards for (4.2.1.) .. 9.7-6465von Willebrand factor, human.............................................. 2701von Willebrand factor, human, assay of (2.7.21.) ................. 268Voriconazole............................................................................ 3921

WWarfarin sodium..................................................................... 3927Warfarin sodium clathrate..................................................... 3928Washes, nasal............................................................................. 868Water (15O) injection .............................................................. 1203Water activity and sorption-desorption isotherms,determination of (water-solid interactions) (2.9.39.)........ 9.7-6331

Water, determination by distillation (2.2.13.) ......................... 31Water for diluting concentrated haemodialysis solutions.. 2627Water for injections ......................................................... 9.1-4215

Water for pharmaceutical use, total organic carbon in(2.2.44.) ...................................................................................... 73

Water for preparation of extracts.......................................... 3932Water in essential oils (2.8.5.) ................................................. 284Water in gases (2.5.28.) ............................................................ 170Water : micro determination (2.5.32.) ........................... 9.4-5107Water, purified ................................................................. 9.4-5475Water : semi-micro determination (2.5.12.) ................. 9.4-5107Water-solid interactions : determination of sorption-desorption isotherms and of water activity (2.9.39.) .. 9.7-6331

Wettability of porous solids including powders (2.9.45.) .... 381Wheat-germ oil, refined......................................................... 3937Wheat-germ oil, virgin........................................................... 3938Wheat starch............................................................................ 3937White beeswax ........................................................................ 1804White horehound ............................................................9.6-6001White peony root.................................................................... 1472White soft paraffin.................................................................. 3270Wild pansy (flowering aerial parts)...................................... 1558Wild thyme.............................................................................. 1559Willow bark ............................................................................. 1561Willow bark dry extract ......................................................... 1562Wool alcohols .......................................................................... 3938Wool fat.................................................................................... 3939Wool fat, hydrogenated.......................................................... 3943Wool fat, hydrous.................................................................... 3944Wormwood.............................................................................. 1563

XXanthan gum.................................................................... 9.2-4627Xenon (133Xe) injection .......................................................... 1204X-ray fluorescence spectrometry (2.2.37.).................... 9.3-4689X-ray powder diffraction (XRPD), characterisationof crystalline and partially crystalline solids by(2.9.33.) ........................................................................... 9.7-6323

Xylazine hydrochloride for veterinary use .......................... 3948Xylitol ....................................................................................... 3949Xylometazoline hydrochloride.............................................. 3951Xylose ....................................................................................... 3953

YYarrow ...................................................................................... 1564Yeasticidal, bactericidal or fungicidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Yellow beeswax........................................................................ 1805Yellow fever vaccine (live) .............................................. 9.6-5973Yellow soft paraffin................................................................. 3271Yersiniosis vaccine (inactivated) for salmonids ........... 9.2-4430Yohimbine hydrochloride ...................................................... 3957Yttrium (90Y) chloride solution for radiolabelling....... 9.7-6537

ZZanamivir hydrate .................................................................. 3961Zanthoxylum bungeanum pericarp...................................... 1565Zidovudine .............................................................................. 3962Zinc acetate dihydrate ............................................................ 3964Zinc acexamate ....................................................................... 3965Zinc chloride ........................................................................... 3967Zinc gluconate......................................................................... 3967Zinc oxide ................................................................................ 3968Zinc stearate ............................................................................ 3968Zinc sulfate heptahydrate ...................................................... 3969Zinc sulfate hexahydrate ........................................................ 3970Zinc sulfate monohydrate...................................................... 3970Zinc undecylenate .................................................................. 3970Ziprasidone hydrochloride monohydrate............................ 3971Ziprasidone mesilate trihydrate ............................................ 3973Zoledronic acid monohydrate........................................ 9.6-6225Zolmitriptan ..................................................................... 9.5-5759Zolpidem tartrate.................................................................... 3975Zopiclone ................................................................................. 3976Zoster (shingles) vaccine (live), herpes......................... 9.6-5963



Zuclopenthixol decanoate...................................................... 3978



Numericsα-1-Proteinasi inhibitor humanum ...................................... 2694

AAbacaviri sulfas ....................................................................... 1619Absinthii herba ........................................................................ 1563Acaciae gummi ........................................................................ 1229Acaciae gummi dispersione desiccatum ................................ 1620Acamprosatum calcicum ........................................................ 1621Acanthopanacis gracilistyli cortex .................................. 9.2-4447Acarbosum ............................................................................... 1622Acari ad producta allergenica ................................................ 3077Acebutololi hydrochloridum................................................... 1624Aceclofenacum .................................................................. 9.3-4835Acemetacinum ......................................................................... 1628Acesulfamum kalicum ............................................................ 1629Acetazolamidum ..................................................................... 1630Acetonum .......................................................................... 9.7-6561Acetylcholini chloridum.......................................................... 1633Acetylcysteinum....................................................................... 1634β-Acetyldigoxinum .................................................................. 1635Acetylenum (1 per centum) in nitrogenio intermixtum ....... 9.3-4836

Achyranthis bidentatae radix.......................................... 9.7-6541Aciclovirum.............................................................................. 1642Acidi methacrylici et ethylis acrylatis polymerisati 1:1 dispersio30 per centum ........................................................................ 3017

Acidi methacrylici et ethylis acrylatis polymerisatum1:1 .................................................................................... 9.6-6159

Acidi methacrylici et methylis methacrylatis polymerisatum1:1 ........................................................................................... 3018

Acidi methacrylici et methylis methacrylatis polymerisatum1:2 ........................................................................................... 3019

Acidum 4-aminobenzoicum ................................................... 1702Acidum aceticum glaciale....................................................... 1632Acidum acetylsalicylicum ....................................................... 1638Acidum adipicum.................................................................... 1649Acidum alginicum................................................................... 1665Acidum amidotrizoicum dihydricum ................................... 1694Acidum aminocaproicum ....................................................... 1703Acidum ascorbicum ......................................................... 9.3-4843Acidum asparticum.......................................................... 9.3-4845Acidum benzoicum ................................................................. 1818Acidum boricum...................................................................... 1859Acidum caprylicum ................................................................. 1938Acidum chenodeoxycholicum................................................. 2026Acidum citricum...................................................................... 2098Acidum citricum monohydricum .......................................... 2099Acidum edeticum .................................................................... 2344Acidum etacrynicum............................................................... 2413Acidum folicum hydricum .............................................. 9.5-5662Acidum formicum ............................................................ 9.4-5376Acidum fusidicum ................................................................... 2552Acidum glutamicum ............................................................... 2593Acidum hydrochloridum concentratum................................ 2704Acidum hydrochloridum dilutum ......................................... 2704Acidum iopanoicum................................................................ 2797Acidum ioxaglicum ................................................................. 2803Acidum lacticum ..................................................................... 2860Acidum lactobionicum ........................................................... 2863Acidum maleicum ................................................................... 2971Acidum malicum..................................................................... 2972Acidum medronicum ad radiopharmaceutica .............. 9.2-4437Acidum mefenamicum ........................................................... 2987Acidum nalidixicum ............................................................... 3115Acidum nicotinicum ........................................................ 9.3-4961Acidum niflumicum ................................................................ 3152Acidum nitricum ..................................................................... 3161Acidum oleicum ...................................................................... 3197Acidum oxolinicum................................................................. 3237Acidum palmiticum ................................................................ 3259Acidum phosphoricum concentratum ................................... 3333

Acidum phosphoricum dilutum............................................. 3334Acidum picricum ad praeparationes homoeopathicas ........ 1587Acidum pipemidicum trihydricum........................................ 3346Acidum salicylicum ................................................................. 3528Acidum (S)-lacticum............................................................... 2861Acidum sorbicum .................................................................... 3622Acidum stearicum ................................................................... 3655Acidum succinicum ad praeparationes homoeopathicas...... 9.5-5621

Acidum sulfuricum ................................................................. 3691Acidum tartaricum ................................................................. 3716Acidum thiocticum.................................................................. 3765Acidum tiaprofenicum ............................................................ 3782Acidum tolfenamicum ............................................................ 3811Acidum tranexamicum........................................................... 3821Acidum trichloroaceticum ...................................................... 3835Acidum undecylenicum .......................................................... 3876Acidum ursodeoxycholicum ................................................... 3880Acidum valproicum ................................................................ 3893Acidum zoledronicum monohydricum .......................... 9.6-6225Acitretinum....................................................................... 9.5-5627Adapalenum ............................................................................ 1646Adeninum ................................................................................ 1647Adenosinum ............................................................................. 1648Adeps A 3-O-desacyl-4-monophosphorylatus ..................... 2207Adeps lanae.............................................................................. 3939Adeps lanae cum aqua............................................................ 3944Adeps lanae hydrogenatus...................................................... 3943Adeps solidus ........................................................................... 2639Adeps solidus cum additamentis ........................................... 2640Adrenalini tartras ................................................................... 1652Adrenalinum ........................................................................... 1650Aer medicinalis ........................................................................ 1653Aer medicinalis artificiosus .................................................... 1655Aether ....................................................................................... 2421Aether anaestheticus ............................................................... 2422Aetherolea .................................................................................. 814Agar .......................................................................................... 1230Agni casti fructus..................................................................... 1231Agni casti fructus extractum siccum ..................................... 1232Agrimoniae herba ................................................................... 1233Akebiae caulis ................................................................... 9.6-5985Alaninum ................................................................................. 1656Albendazolum................................................................... 9.6-6009Albumini humani solutio ....................................................... 2660Alchemillae herba.................................................................... 1235Alcohol 2,4-dichlorobenzylicus .............................................. 2242Alcohol benzylicus ............................................................ 9.4-5327Alcohol cetylicus ...................................................................... 2023Alcohol cetylicus et stearylicus ............................................... 2019Alcohol cetylicus et stearylicus emulsificans A ..................... 2019Alcohol cetylicus et stearylicus emulsificans B ..................... 2021Alcoholes adipis lanae............................................................. 3938Alcohol isopropylicus .............................................................. 2819Alcohol oleicus ......................................................................... 3199Alcohol stearylicus................................................................... 3657Alcuronii chloridum................................................................ 1658Alfacalcidolum......................................................................... 1660Alfadexum......................................................................... 9.3-4838Alfentanili hydrochloridum hydricum ........................... 9.7-6562Alfuzosini hydrochloridum ............................................. 9.1-4123Alimemazini hemitartras ....................................................... 1666Allantoinum............................................................................. 1667Allii sativi bulbi pulvis ..................................................... 9.6-5992Allium sativum ad praeparationes homoeopathicas............ 1590Allopurinolum ......................................................................... 1668Almagatum .............................................................................. 1670Aloe barbadensis ..................................................................... 1236Aloe capensis ............................................................................ 1237Aloes extractum siccum normatum....................................... 1238Alovudini (18F) solutio iniectabilis......................................... 1127Alprazolamum......................................................................... 1672Alprenololi hydrochloridum................................................... 1674



Alprostadilum .......................................................................... 1675Alteplasum ad iniectabile ....................................................... 1677Althaeae folium ....................................................................... 1429Althaeae radix ......................................................................... 1430Altizidum ................................................................................. 1681Alumen ..................................................................................... 1682Aluminii chloridum hexahydricum....................................... 1682Aluminii hydroxidum hydricum ad adsorptionem ............. 1682Aluminii magnesii silicas................................................. 9.3-4839Aluminii natrii silicas ............................................................. 1686Aluminii oxidum hydricum ................................................... 1684Aluminii phosphas hydricus................................................... 1686Aluminii phosphatis liquamen............................................... 1685Aluminii stearas ...................................................................... 1687Aluminii sulfas ........................................................................ 1689Alverini citras ................................................................... 9.3-4841Amanita phalloides ad praeparationes homoeopathicas...... 9.5-5621

Amantadini hydrochloridum ................................................. 1691Ambroxoli hydrochloridum............................................. 9.2-4499Amfetamini sulfas ............................................................ 9.7-6563Amikacini sulfas ............................................................... 9.6-6010Amikacinum ............................................................................ 1696Amiloridi hydrochloridum dihydricum ......................... 9.7-6564Aminoglutethimidum ............................................................. 1704Amiodaroni hydrochloridum ................................................. 1706Amisulpridum .................................................................. 9.6-6013Amitriptylini hydrochloridum ............................................... 1709Amlodipini besilas ................................................................... 1710Ammoniae (13N) solutio iniectabilis ...................................... 1129Ammoniae solutio concentrata .............................................. 1712Ammonii bromidum ............................................................... 1714Ammonii carbonas ad praeparationes homoeopathicas ...... 9.3-4827

Ammonii chloridum ............................................................... 1715Ammonii glycyrrhizas............................................................. 1716Ammonii hydrogenocarbonas ................................................ 1717Ammonio methacrylatis copolymerum A ...................... 9.6-6014Ammonio methacrylatis copolymerum B ...................... 9.6-6015Amobarbitalum ....................................................................... 1717Amobarbitalum natricum ...................................................... 1718Amomi fructus......................................................................... 1239Amomi fructus rotundus ........................................................ 1502Amorolfini hydrochloridum ............................................ 9.7-6566Amoxicillinum natricum ........................................................ 1720Amoxicillinum trihydricum ................................................... 1723Amphotericinum B.................................................................. 1725Ampicillinum ........................................................................... 1727Ampicillinum natricum .......................................................... 1729Ampicillinum trihydricum ..................................................... 1731Amygdalae oleum raffinatum ................................................ 1671Amygdalae oleum virginale.................................................... 1671Amyla hydroxyethyla ....................................................... 9.6-6208Amylmetacresolum.................................................................. 1733Amylum hydroxypropylum .................................................... 3645Amylum hydroxypropylum pregelificatum........................... 3647Amylum pregelificatum .......................................................... 3649Anamirta cocculus ad praeparationes homoeopathicas ...... 1597Anastrozolum ................................................................... 9.3-4842Andrographidis herba ...................................................... 9.3-4807Anemarrhenae asphodeloides rhizoma ................................. 1241Angelicae archangelicae radix................................................ 1242Angelicae dahuricae radix ............................................... 9.3-4808Angelicae pubescentis radix............................................. 9.3-4810Angelicae sinensis radix ................................................... 9.1-4100Anisi aetheroleum ................................................................... 1248Anisi fructus...................................................................... 9.2-4448Anisi stellati aetheroleum ....................................................... 1530Anisi stellati fructus ................................................................ 1529Antazolini hydrochloridum.................................................... 1737Anticorpora monoclonalia ad usum humanum .................... 826Antithrombinum III humanum densatum ........................... 2664Apis mellifera ad praeparationes homoeopathicas............... 1592

Apomorphini hydrochloridum hemihydricum..................... 1744Aprepitantum .......................................................................... 1746Aprotinini solutio concentrata ........................................ 9.6-6018Aprotininum ..................................................................... 9.6-6016Aqua ad dilutionem solutionum concentratarum adhaemodialysim ...................................................................... 2627

Aqua ad extracta praeparanda.............................................. 3932Aqua ad iniectabile .......................................................... 9.1-4215Aquae (15O) solutio iniectabilis .............................................. 1203Aquae tritiatae (3H) solutio iniectabilis ................................ 1202Aqua purificata ................................................................ 9.4-5475Arachidis oleum hydrogenatum...................................... 9.6-6021Arachidis oleum raffinatum ............................................ 9.6-6022Argenti nitras........................................................................... 3552Argentum colloidale ad usum externum............................... 3552Arginini aspartas..................................................................... 1754Arginini hydrochloridum ....................................................... 1755Argininum................................................................................ 1753Argon ........................................................................................ 1756Aripiprazolum ......................................................................... 1757Arnicae flos .............................................................................. 1251Arnicae tinctura ...................................................................... 1253Arsenii trioxidum ad praeparationes homoeopathicas .. 9.5-5623Articaini hydrochloridum ...................................................... 1758Ascorbylis palmitas ................................................................. 1762Asparaginum monohydricum ................................................ 1762Aspartamum ............................................................................ 1763Astragali mongholici radix .............................................. 9.2-4449Atazanaviri sulfas ............................................................ 9.7-6568Atenololum ....................................................................... 9.1-4124Atomoxetini hydrochloridum ................................................ 1767Atorvastatinum calcicum trihydricum.................................. 1769Atovaquonum .......................................................................... 1771Atractylodis lanceae rhizoma.......................................... 9.7-6542Atractylodis macrocephalae rhizoma ............................. 9.7-6544Atracurii besilas....................................................................... 1772Atropa belladonna ad praeparationes homoeopathicas ....... 9.2-4492

Atropini sulfas .................................................................. 9.3-4849Atropinum ........................................................................ 9.3-4847Aucklandiae radix ............................................................ 9.2-4450Aurantii amari epicarpii et mesocarpii tinctura.................. 1284Aurantii amari epicarpium et mesocarpium ....................... 1283Aurantii amari flos ................................................................. 1284Aurantii dulcis aetheroleum .................................................. 1535Auricularia ................................................................................ 855Azaperonum ad usum veterinarium ..................................... 1778Azathioprinum ........................................................................ 1779Azelastini hydrochloridum ..................................................... 1780Azithromycinum .............................................................. 9.6-6022

BBacampicillini hydrochloridum ............................................. 1787Bacitracinum .................................................................... 9.6-6029Bacitracinum zincum....................................................... 9.6-6033Baclofenum .............................................................................. 1794Ballotae nigrae herba .............................................................. 1289Balsamum peruvianum .......................................................... 1479Balsamum tolutanum ............................................................. 1541Bambuteroli hydrochloridum ................................................ 1795Barbitalum ............................................................................... 1797Barii chloridum dihydricum ad praeparationeshomoeopathicas ..................................................................... 1594

Barii sulfas ............................................................................... 1797BCG ad immunocurationem.................................................... 894Beclometasoni dipropionas..................................................... 1799Beclometasoni dipropionas monohydricus ........................... 1802Belamcandae chinensis rhizoma ............................................ 1266Belladonnae folii extractum siccum normatum ............ 9.2-4453Belladonnae folii tinctura normata ................................ 9.2-4454Belladonnae folium .......................................................... 9.2-4452Belladonnae pulvis normatus.......................................... 9.2-4456



Benazeprili hydrochloridum .................................................. 1806Bendroflumethiazidum ........................................................... 1807Benperidolum .......................................................................... 1808Benserazidi hydrochloridum .................................................. 1810Bentonitum .............................................................................. 1811Benzalkonii chloridi solutio.................................................... 1813Benzalkonii chloridum ........................................................... 1811Benzathini benzylpenicillinum tetrahydricum .............. 9.6-6037Benzathini phenoxymethylpenicillinum tetrahydricum ....... 9.6-6177

Benzbromaronum ................................................................... 1815Benzethonii chloridum............................................................ 1816Benzocainum .................................................................... 9.4-5326Benzoe sumatranus ................................................................. 1273Benzoe tonkinensis .................................................................. 1272Benzois sumatrani tinctura .................................................... 1274Benzois tonkinensis tinctura .................................................. 1274Benzoylis peroxidum cum aqua............................................. 1819Benzylis benzoas ...................................................................... 1822Benzylpenicillinum kalicum ............................................ 9.2-4505Benzylpenicillinum natricum.......................................... 9.2-4508Benzylpenicillinum procainum ....................................... 9.2-4506Betacarotenum ................................................................. 9.7-6573Betadexum ........................................................................ 9.3-4857Betahistini dihydrochloridum ................................................ 1831Betahistini mesilas................................................................... 1832Betamethasoni acetas.............................................................. 1835Betamethasoni dipropionas ............................................. 9.3-4858Betamethasoni natrii phosphas.............................................. 1839Betamethasoni valeras ............................................................ 1840Betamethasonum..................................................................... 1833Betaxololi hydrochloridum..................................................... 1842Betulae folium ......................................................................... 1276Bezafibratum ........................................................................... 1843Bicalutamidum ........................................................................ 1845Bifonazolum............................................................................. 1846Biotinum ........................................................................... 9.5-5631Biperideni hydrochloridum .................................................... 1848Bisacodylum............................................................................. 1850Bismuthi subcarbonas ............................................................. 1851Bismuthi subgallas .................................................................. 1852Bismuthi subnitras ponderosus .............................................. 1853Bismuthi subsalicylas .............................................................. 1854Bisoprololi fumaras ................................................................. 1855Bistortae rhizoma .................................................................... 1278Bleomycini sulfas ..................................................................... 1857Boldi folii extractum siccum................................................... 1293Boldi folium ............................................................................. 1292Boldinum........................................................................... 9.7-6574Boraginis officinalis oleum raffinatum ................................. 1858Borax ........................................................................................ 1859Brimonidini tartras ................................................................. 1864Bromazepamum ...................................................................... 1865Bromhexini hydrochloridum........................................... 9.1-4137Bromocriptini mesilas ............................................................. 1868Bromperidoli decanoas ........................................................... 1872Bromperidolum ....................................................................... 1870Brompheniramini maleas ...................................................... 1873Brotizolamum.......................................................................... 1875Budesonidum ........................................................................... 1876Bufexamacum.......................................................................... 1878Buflomedili hydrochloridum .................................................. 1879Bumetanidum .......................................................................... 1881Bupivacaini hydrochloridum ................................................. 1882Bupleuri radix................................................................... 9.4-5303Buprenorphini hydrochloridum............................................. 1886Buprenorphinum ..................................................................... 1884Buserelinum ............................................................................. 1887Buspironi hydrochloridum ..................................................... 1889Busulfanum.............................................................................. 1891Butylhydroxyanisolum............................................................ 1893Butylhydroxytoluenum ........................................................... 1894Butylis parahydroxybenzoas .................................................. 1892

CC1-esterasi inhibitor humanus............................................... 2665Cabergolinum .......................................................................... 1897Cadmii sulfas hydricus ad praeparationeshomoeopathicas ..................................................................... 1596

Calcifediolum monohydricum ........................................ 9.6-6045Calcii acetas ............................................................................. 1910Calcii ascorbas ......................................................................... 1911Calcii carbonas ........................................................................ 1912Calcii chloridum dihydricum ................................................. 1912Calcii chloridum hexahydricum ............................................ 1913Calcii dobesilas monohydricus............................................... 1914Calcii fluoridum ad praeparationes homoeopathicas ... 9.5-5624Calcii folinas hydricus ..................................................... 9.7-6579Calcii glucoheptonas ............................................................... 1917Calcii gluconas......................................................................... 1917Calcii gluconas ad iniectabile................................................. 1919Calcii gluconas anhydricus..................................................... 1918Calcii glycerophosphas ............................................................ 1920Calcii hydrogenophosphas ............................................... 9.6-6050Calcii hydrogenophosphas dihydricus ................................... 1922Calcii hydroxidum .................................................................. 1923Calcii iodidum tetrahydricum ad praeparationeshomoeopathicas ..................................................................... 1596

Calcii lactas.............................................................................. 1923Calcii lactas monohydricus .................................................... 1924Calcii lactas pentahydricus .................................................... 1924Calcii lactas trihydricus .......................................................... 1925Calcii laevulinas dihydricus ................................................... 1928Calcii levofolinas hydricus............................................... 9.7-6581Calcii pantothenas .................................................................. 1929Calcii stearas............................................................................ 1930Calcii sulfas dihydricus ........................................................... 1932Calcipotriolum.................................................................. 9.6-6046Calcipotriolum monohydricum ...................................... 9.6-6048Calcitoninum salmonis........................................................... 1906Calcitriolum............................................................................. 1909Calendulae flos ........................................................................ 1297Camelliae sinensis non fermentata folia ........................ 9.4-5304Camphora racemica ................................................................ 1934Candesartanum cilexetili ....................................................... 1935Capecitabinum ........................................................................ 1937Capsici extractum spissum normatum .................................. 1303Capsici fructus ......................................................................... 1300Capsici oleoresina raffinata et normata ................................ 1302Capsici tinctura normata ....................................................... 1304Capsulae ............................................................................ 9.4-5287Captoprilum ............................................................................ 1940Carbacholum ........................................................................... 1942Carbamazepinum.................................................................... 1943Carbasalatum calcicum .......................................................... 1945Carbidopum ...................................................................... 9.4-5333Carbimazolum......................................................................... 1948Carbo activatus ....................................................................... 2025Carbocisteinum ....................................................................... 1949Carbomera ............................................................................... 1950Carbonei dioxidum ................................................................. 1951Carbonei monoxidum ............................................................. 1953Carbonei monoxidum (15O) ................................................... 1130Carbonei monoxidum (5 per centum) in nitrogeniointermixtum.................................................................... 9.3-4865

Carboplatinum ........................................................................ 1954Carboprostum trometamolum ............................................... 1955Carboxymethylamylum natricum A .............................. 9.1-4200Carboxymethylamylum natricum B............................... 9.1-4202Carboxymethylamylum natricum C ..................................... 3604Carisoprodolum....................................................................... 1956Carmellosum............................................................................ 1957Carmellosum calcicum .................................................... 9.4-5335Carmellosum natricum........................................................... 1958Carmellosum natricum conexum .......................................... 2174Carmellosum natricum substitutum humile ........................ 1958



Carmustinum .......................................................................... 1960Carprofenum ad usum veterinarium .................................... 1961Carrageenanum....................................................................... 1962Carteololi hydrochloridum ..................................................... 1963Carthami flos ........................................................................... 1503Carthami oleum raffinatum................................................... 3523Carvedilolum ........................................................................... 1965Carvi aetheroleum .................................................................. 1306Carvi fructus ............................................................................ 1305Caryophylli floris aetheroleum............................................... 1323Caryophylli flos........................................................................ 1322Cefaclorum............................................................................... 1969Cefadroxilum monohydricum................................................ 1970Cefalexinum monohydricum ................................................. 1972Cefalotinum natricum ............................................................ 1973Cefamandoli nafas .................................................................. 1974Cefapirinum natricum ............................................................ 1976Cefatrizinum propylen glycolum ........................................... 1977Cefazolinum natricum ..................................................... 9.7-6584Cefepimi dihydrochloridum monohydricum ................. 9.2-4513Cefiximum ........................................................................ 9.4-5335Cefoperazonum natricum....................................................... 1984Cefotaximum natricum .......................................................... 1985Cefoxitinum natricum ............................................................ 1987Cefpodoximum proxetili ......................................................... 1989Cefprozilum monohydricum ........................................... 9.4-5337Cefradinum .............................................................................. 1994Ceftazidimum pentahydricum ........................................ 9.3-4865Ceftazidimum pentahydricum et natrii carbonas adiniectabile ........................................................................ 9.3-4867

Ceftriaxonum natricum.......................................................... 2000Cefuroximum axetili ........................................................ 9.2-4515Cefuroximum natricum.......................................................... 2003Celecoxibum............................................................................. 2004Celiprololi hydrochloridum .................................................... 2005Cellulae stirpes haematopoieticae humanae ................. 9.7-6627Cellulosi acetas ................................................................. 9.7-6587Cellulosi acetas butyras........................................................... 2008Cellulosi acetas phthalas ......................................................... 2009Cellulosi pulvis......................................................................... 2013Cellulosum microcristallinum......................................... 9.6-6052Cellulosum microcristallinum et carmellosum natricum .... 3068Centaurii herba ....................................................................... 1310Centellae asiaticae herba ........................................................ 1311Cera alba .................................................................................. 1804Cera carnauba ......................................................................... 1960Cera flava ................................................................................. 1805Cetirizini dihydrochloridum .................................................. 2017Cetobemidoni hydrochloridum .............................................. 2848Cetostearylis isononanoas ...................................................... 2022Cetrimidum ............................................................................. 2022Cetylis palmitas ....................................................................... 2024Cetylpyridinii chloridum ........................................................ 2025Chamomillae romanae flos .................................................... 1313Chelidonii herba ...................................................................... 1380Chinidini sulfas ....................................................................... 3461Chinini hydrochloridum ......................................................... 3463Chinini sulfas ........................................................................... 3464Chitosani hydrochloridum ..................................................... 2028Chlorali hydras ........................................................................ 2029Chlorambucilum ..................................................................... 2029Chloramphenicoli natrii succinas .......................................... 2033Chloramphenicoli palmitas .................................................... 2032Chloramphenicolum ........................................................ 9.7-6588Chlorcyclizini hydrochloridum .............................................. 2034Chlordiazepoxidi hydrochloridum ........................................ 2036Chlordiazepoxidum................................................................. 2035Chlorhexidini diacetas ..................................................... 9.4-5339Chlorhexidini digluconatis solutio .................................. 9.3-4871Chlorhexidini dihydrochloridum .................................... 9.4-5341Chlormadinoni acetas............................................................. 2043Chlorobutanolum ............................................................. 9.6-6055Chlorobutanolum hemihydricum ................................... 9.6-6056

Chlorocresolum........................................................................ 2046Chloroquini phosphas ............................................................. 2047Chloroquini sulfas ................................................................... 2048Chlorphenamini maleas ......................................................... 2048Chlorpromazini hydrochloridum .......................................... 2050Chlorprothixeni hydrochloridum .......................................... 2052Chlortalidonum ....................................................................... 2054Chlortetracyclini hydrochloridum ......................................... 2055Cholecalciferoli pulvis ............................................................. 2061Cholecalciferolum.................................................................... 2058Cholecalciferolum densatum oleosum ............................ 9.6-6057Cholecalciferolum in aqua dispergibile ................................. 2062Cholesterolum .......................................................................... 2064Cholesterolum ad usum parenteralem ........................... 9.2-4517Cholini ([11C]methyl) solutio iniectabilis ....................... 9.7-6531Chondroitini natrii sulfas ....................................................... 2067Chorda resorbilis sterilis ......................................................... 1207Chorda resorbilis sterilis in fuso ad usum veterinarium ..... 1219Chromii (51Cr) edetatis solutio iniectabilis ........................... 1131Chymotrypsinum..................................................................... 2069Ciclesonidum ........................................................................... 2070Ciclopirox olaminum .............................................................. 2072Ciclopiroxum ........................................................................... 2071Ciclosporinum ......................................................................... 2074Cilastatinum natricum ........................................................... 2075Cilazaprilum ............................................................................ 2077Cimetidini hydrochloridum............................................. 9.4-5345Cimetidinum..................................................................... 9.4-5343Cimicifugae rhizoma ............................................................... 1285Cinchocaini hydrochloridum .......................................... 9.6-6059Cinchonae cortex..................................................................... 1314Cinchonae extractum fluidum normatum............................ 1316Cineolum .................................................................................. 2083Cinnamomi cassiae aetheroleum ........................................... 1310Cinnamomi cortex .................................................................. 1317Cinnamomi zeylanici corticis aetheroleum .......................... 1318Cinnamomi zeylanici folii aetheroleum ................................ 1318Cinnarizinum .......................................................................... 2084Ciprofibratum .......................................................................... 2085Ciprofloxacini hydrochloridum ............................................. 2088Ciprofloxacinum...................................................................... 2086Cisatracurii besilas ........................................................... 9.4-5347Cisplatinum ............................................................................. 2094Citaloprami hydrobromidum.......................................... 9.3-4876Citaloprami hydrochloridum .......................................... 9.3-4877Citri reticulatae aetheroleum ................................................. 1428Citri reticulatae epicarpium et mesocarpium....................... 1426Citronellae aetheroleum ......................................................... 1319Cladribinum ............................................................................ 2100Clarithromycinum ........................................................... 9.4-5351Clazurilum ad usum veterinarium ....................................... 2104Clebopridi malas ..................................................................... 2106Clemastini fumaras .......................................................... 9.3-4879Clematidis armandii caulis ............................................. 9.3-4813Clenbuteroli hydrochloridum................................................. 2109Clindamycini hydrochloridum........................................ 9.3-4880Clindamycini phosphas .......................................................... 2111Clioquinolum ........................................................................... 2114Clobazamum ........................................................................... 2115Clobetasoli propionas.............................................................. 2116Clobetasoni butyras................................................................. 2118Clofaziminum .......................................................................... 2120Clofibratum.............................................................................. 2122Clomifeni citras ................................................................ 9.5-5635Clomipramini hydrochloridum.............................................. 2124Clonazepamum ....................................................................... 2126Clonidini hydrochloridum...................................................... 2127Clopamidum ............................................................................ 2128Clopidogreli besilas.................................................................. 2129Clopidogreli hydrochloridum ................................................. 2131Clopidogreli hydrogenosulfas ................................................. 2133Closantelum natricum dihydricum ad usum veterinarium.. 9.7-6589



Clotrimazolum ........................................................................ 2136Cloxacillinum natricum ......................................................... 2137Clozapinum ............................................................................. 2139Cocaini hydrochloridum......................................................... 2140Cocois oleum raffinatum ........................................................ 2141Cocoylis caprylocapras ............................................................ 2142Codeini hydrochloridum dihydricum............................. 9.5-5636Codeini phosphas hemihydricus ..................................... 9.5-5641Codeini phosphas sesquihydricus........................................... 2148Codeinum monohydricum .............................................. 9.5-5639Codergocrini mesilas ............................................................... 2149Codonopsidis radix........................................................... 9.3-4815Coffeinum ................................................................................ 1898Coffeinum monohydricum ..................................................... 1899Coicis semen...................................................................... 9.2-4457Colae semen ............................................................................. 1326Colchicinum ...................................................................... 9.4-5354Colestyraminum ...................................................................... 2164Colistimethatum natricum .............................................. 9.4-5356Colistini sulfas .................................................................. 9.6-6060Colophonium ........................................................................... 1327Compressi .......................................................................... 9.3-4790Copolymerum macrogolo et alcoholi poly(vinylico)constatum............................................................................... 2945

Copolymerum methacrylatis butylati basicum.............. 9.4-5325Copovidonum ................................................................... 9.3-4882Coptidis rhizoma .............................................................. 9.1-4102Coriandri aetheroleum ........................................................... 1330Coriandri fructus..................................................................... 1329Corpora ad usum pharmaceuticum ............................... 9.3-4777Cortisoni acetas ....................................................................... 2170Corydalis rhizoma ............................................................ 9.7-6545Crataegi folii cum flore extractum fluidum quantificatum .. 1387Crataegi folii cum flore extractum siccum ............................ 1386Crataegi folium cum flore....................................................... 1385Crataegi fructus ....................................................................... 1384Cresolum crudum.................................................................... 2173Croci sativi stigma ad praeparationes homoeopathicas ...... 1599Crospovidonum ................................................................ 9.7-6591Crotamitonum ......................................................................... 2177Cupri acetas monohydricus ad praeparationeshomoeopathicas ..................................................................... 1599

Cupri sulfas .............................................................................. 2169Cupri sulfas pentahydricus..................................................... 2170Cupri tetramibi tetrafluoroboras ad radiopharmaceutica ... 9.2-4435

Cuprum ad praeparationes homoeopathicas ........................ 1600Curcumae longae rhizoma ..................................................... 1545Curcumae zanthorrhizae rhizoma ........................................ 1544Cyamopsidis seminis pulvis .................................................... 1381Cyanocobalamini (57Co) capsulae ......................................... 1132Cyanocobalamini (57Co) solutio ............................................ 1133Cyanocobalamini (58Co) capsulae ......................................... 1134Cyanocobalamini (58Co) solutio ............................................ 1134Cyanocobalaminum................................................................ 2178Cyclizini hydrochloridum ....................................................... 2179Cyclopentolati hydrochloridum ............................................. 2180Cyclophosphamidum .............................................................. 2181Cynarae folii extractum siccum ...................................... 9.4-5302Cynarae folium ................................................................. 9.4-5301Cyproheptadini hydrochloridum ........................................... 2182Cyproteroni acetas .................................................................. 2183Cysteini hydrochloridum monohydricum............................. 2185Cystinum ........................................................................... 9.6-6062Cytarabinum..................................................................... 9.6-6063

DDacarbazinum ......................................................................... 2193Dalteparinum natricum ......................................................... 2194Danaparoidum natricum ....................................................... 2196Dapsonum................................................................................ 2198Daunorubicini hydrochloridum............................................. 2199

D-Camphora ............................................................................ 1932Decylis oleas ............................................................................. 2200Deferiproni solutio peroralis ........................................... 9.7-6595Deferipronum ................................................................... 9.5-5647Deferoxamini mesilas ...................................................... 9.3-4887Delphinium staphisagria ad praeparationeshomoeopathicas ..................................................................... 1612

Dembrexini hydrochloridum monohydricum ad usumveterinarium ................................................................... 9.2-4526

Demeclocyclini hydrochloridum ............................................ 2203Deptropini citras...................................................................... 2205Dequalinii chloridum.............................................................. 2206Desfluranum ............................................................................ 2209Desipramini hydrochloridum................................................. 2210Deslanosidum .......................................................................... 2211Desloratadinum ....................................................................... 2212Desmopressinum ..................................................................... 2213Desogestrelum .......................................................................... 2215Detomidini hydrochloridum ad usum veterinarium ........... 2217Dexamethasoni acetas ............................................................ 2220Dexamethasoni isonicotinas................................................... 2222Dexamethasoni natrii phosphas ............................................ 2223Dexamethasonum ................................................................... 2218Dexamfetamini sulfas ...................................................... 9.7-6595Dexchlorpheniramini maleas ................................................. 2226Dexpanthenolum ..................................................................... 2227Dextranomerum ...................................................................... 2231Dextranum 1 ad iniectabile ............................................ 9.4-5363Dextranum 40 ad iniectabile.................................................. 2229Dextranum 60 ad iniectabile.................................................. 2230Dextranum 70 ad iniectabile.................................................. 2231Dextrinum......................................................................... 9.6-6069Dextromethorphani hydrobromidum ................................... 2233Dextromoramidi tartras ......................................................... 2234Dextropropoxypheni hydrochloridum................................... 2235Diacereinum ............................................................................ 2236Diazepamum ........................................................................... 2238Diazoxidum ............................................................................. 2240Dibrompropamidini diisetionas............................................. 2240Dibutylis phthalas ................................................................... 2241Diclazurilum ad usum veterinarium .................................... 2243Diclofenacum kalicum ............................................................ 2245Diclofenacum natricum .......................................................... 2246Dicloxacillinum natricum ...................................................... 2248Dicycloverini hydrochloridum ........................................ 9.1-4147Didanosinum ........................................................................... 2250Dienogestum ............................................................................ 2252Diethylcarbamazini citras ...................................................... 2254Diethylenglycoli aether monoethylicus .................................. 2256Diethylenglycoli palmitostearas ............................................. 2257Diethylis phthalas.................................................................... 2253Diethylstilbestrolum ................................................................ 2258Difloxacini hydrochloridum trihydricum ad usumveterinarium .......................................................................... 2259

Digitalis purpurea ad praeparationes homoeopathicas ........ 9.6-6005

Digitalis purpureae folium ..................................................... 1336Digitoxinum............................................................................. 2260Digoxinum ............................................................................... 2261Dihydralazini sulfas hydricus ......................................... 9.2-4528Dihydrocodeini hydrogenotartras.......................................... 2266Dihydroergocristini mesilas .................................................... 2267Dihydroergotamini mesilas .................................................... 2269Dihydroergotamini tartras ..................................................... 2271Dihydrostreptomycini sulfas ad usum veterinarium .... 9.6-6070Dihydrotachysterolum ..................................................... 9.6-6072Dikalii clorazepas monohydricus.................................... 9.7-6597Dikalii phosphas ...................................................................... 2292Diltiazemi hydrochloridum .................................................... 2276Dimenhydrinatum .................................................................. 2277Dimercaprolum ....................................................................... 2279Dimethylacetamidum ............................................................. 2280Dimethylis sulfoxidum............................................................ 2279



Dimeticonum ........................................................................... 2281Dimetindeni maleas ................................................................ 2282Dinatrii clodronas tetrahydricus ........................................... 2119Dinatrii edetas ......................................................................... 2297Dinatrii etidronas.................................................................... 2433Dinatrii pamidronas pentahydricus ...................................... 3259Dinatrii phosphas .................................................................... 2298Dinatrii phosphas dihydricus ................................................. 2299Dinatrii phosphas dodecahydricus ................................. 9.6-6073Dinitrogenii oxidum ............................................................... 3166Dinoprostonum ................................................................ 9.2-4529Dinoprostum trometamolum ................................................. 2283Dioscoreae nipponicae rhizoma ...................................... 9.5-5613Dioscoreae oppositifoliae rhizoma ......................................... 1337Diosminum .............................................................................. 2286Diphenhydramini hydrochloridum ....................................... 2288Diphenoxylati hydrochloridum.............................................. 2289Dipivefrini hydrochloridum ................................................... 2290Diprophyllinum ....................................................................... 2293Dipyridamolum ....................................................................... 2294Dirithromycinum .................................................................... 2296Disopyramidi phosphas .......................................................... 2301Disopyramidum....................................................................... 2300Disulfiramum .......................................................................... 2302Dithranolum ............................................................................ 2303DL-Methioninum ..................................................................... 3025DL-α-Tocopherylis hydrogenosuccinas .................................. 3806Dobutamini hydrochloridum ................................................. 2304Docetaxelum ............................................................................ 2305Docetaxelum trihydricum ...................................................... 2307Dodecylis gallas ....................................................................... 2309Domperidoni maleas............................................................... 2312Domperidonum ....................................................................... 2310Dopamini hydrochloridum .................................................... 2313Dopexamini dihydrochloridum ............................................. 2315Dorzolamidi hydrochloridum ................................................ 2316Dosulepini hydrochloridum ............................................ 9.7-6598Doxaprami hydrochloridum .................................................. 2319Doxazosini mesilas .................................................................. 2320Doxepini hydrochloridum ...................................................... 2322Doxorubicini hydrochloridum ............................................... 2323Doxycyclini hyclas ................................................................... 2324Doxycyclinum monohydricum............................................... 2326Doxylamini hydrogenosuccinas ............................................. 2328Droperidolum .......................................................................... 2329Drospirenonum ....................................................................... 2331Drynariae rhizoma........................................................... 9.2-4459Duloxetini hydrochloridum.................................................... 2332Dutasteridum........................................................................... 2334Dydrogesteronum .................................................................... 2336

EEbastinum ......................................................................... 9.6-6077Echinaceae angustifoliae radix............................................... 1447Echinaceae pallidae radix....................................................... 1467Echinaceae purpureae herba .................................................. 1486Echinaceae purpureae radix................................................... 1488Ecliptae herba ................................................................... 9.2-4461Econazoli nitras ....................................................................... 2343Econazolum ............................................................................. 2342Edrophonii chloridum............................................................. 2345Eleutherococci radix ................................................................ 1344Emedastini difumaras............................................................. 2346Emplastra transcutanea............................................................ 873Enalaprilatum dihydricum..................................................... 2349Enalaprili maleas .................................................................... 2348Enilconazolum ad usum veterinarium ................................. 2351Enoxaparinum natricum........................................................ 2352Enoxolonum............................................................................. 2354Enrofloxacinum ad usum veterinarium ........................ 9.2-4535Entacaponum........................................................................... 2357Entecavirum monohydricum .......................................... 9.7-6603

Ephedrae herba ....................................................................... 1346Ephedrini hydrochloridum ..................................................... 2362Ephedrini racemici hydrochloridum ..................................... 2363Ephedrinum ............................................................................. 2360Ephedrinum hemihydricum ................................................... 2361Epinastini hydrochloridum .................................................... 2364Epirubicini hydrochloridum................................................... 2365Eplerenonum............................................................................ 2367Equiseti herba .......................................................................... 1347Ergocalciferolum............................................................... 9.7-6604Ergometrini maleas ................................................................. 2370Ergotamini tartras................................................................... 2371Erythritolum ............................................................................ 2373Erythromycini estolas.............................................................. 2378Erythromycini ethylsuccinas ........................................... 9.3-4893Erythromycini lactobionas .............................................. 9.2-4536Erythromycini stearas ............................................................. 2388Erythromycinum ..................................................................... 2374Erythropoietini solutio concentrata ................................ 9.6-6078Escitaloprami oxalas ............................................................... 2397Escitalopramum ...................................................................... 2395Eserini salicylas ....................................................................... 3335Esketamini hydrochloridum............................................ 9.3-4895Esomeprazolum magnesicum dihydricum ............................ 2401Esomeprazolum magnesicum trihydricum ........................... 2402Esomeprazolum natricum ............................................... 9.7-6606Estradioli benzoas ................................................................... 2404Estradioli valeras ..................................................................... 2407Estradiolum hemihydricum ............................................ 9.1-4151Estriolum........................................................................... 9.5-5651Estrogeni coniuncti.................................................................. 2410Etamsylatum ............................................................................ 2414Etanerceptum.................................................................... 9.5-5652Ethacridini lactas monohydricus ........................................... 2415Ethambutoli hydrochloridum ................................................ 2416Ethanolum (96 per centum) ................................................... 2417Ethanolum anhydricum ......................................................... 2419Ethinylestradiolum .................................................................. 2422Ethionamidum......................................................................... 2424Ethosuximidum ................................................................ 9.6-6082Ethylcellulosum................................................................. 9.7-6608Ethylendiaminum.................................................................... 2431Ethylenglycoli monopalmitostearas ....................................... 2430Ethylis acetas............................................................................ 2427Ethylis oleas ............................................................................. 2428Ethylis parahydroxybenzoas................................................... 2428Ethylis parahydroxybenzoas natricus.................................... 3577Ethylmorphini hydrochloridum ............................................. 2431Etilefrini hydrochloridum....................................................... 2433Etodolacum .............................................................................. 2435Etofenamatum ......................................................................... 2437Etomidatum ............................................................................. 2439Etoposidum ....................................................................... 9.1-4152Eucalypti aetheroleum ............................................................ 1349Eucalypti folium ...................................................................... 1349Eucommiae cortex............................................................ 9.2-4462Eugenolum ............................................................................... 2443Everolimusum ................................................................... 9.7-6610Evodiae fructus ................................................................. 9.6-5990Exemestanum .......................................................................... 2445

FFactor humanus von Willebrandi.......................................... 2701Factoris IX coagulationis humani (ADNr) pulvis ad solutioneminiectabilem .................................................................... 9.3-4920

Factoris IX coagulationis humani (ADNr) solutioconcentrata ..................................................................... 9.3-4915

Factoris VIIa coagulationis humani (ADNr) solutioconcentrata ..................................................................... 9.5-5687

Factor IX coagulationis humanus.......................................... 2674Factor VII coagulationis humanus ........................................ 2666Factor VIII coagulationis humanus....................................... 2672



Factor VIII coagulationis humanus (ADNr) ........................ 2673Factor XI coagulationis humanus.......................................... 2681Fagopyri herba ......................................................................... 1294Famotidinum ........................................................................... 2449Febantelum ad usum veterinarium ....................................... 2450Felbinacum .............................................................................. 2451Felodipinum............................................................................. 2452Felypressinum .......................................................................... 2454Fenbendazolum ad usum veterinarium................................ 2455Fenbufenum ............................................................................. 2456Fenofibratum ........................................................................... 2457Fenoteroli hydrobromidum .................................................... 2458Fentanyli citras ................................................................. 9.4-5374Fentanylum ....................................................................... 9.4-5373Fenticonazoli nitras ................................................................ 2462Ferri chloridum hexahydricum.............................................. 2463Ferrosi fumaras ....................................................................... 2464Ferrosi gluconas ....................................................................... 2465Ferrosi sulfas desiccatus .......................................................... 2466Ferrosi sulfas heptahydricus ................................................... 2467Ferrum ad praeparationes homoeopathicas ......................... 1601Fexofenadini hydrochloridum................................................ 2468Fibrini glutinum ............................................................... 9.7-6615Fibrinogenum humanum ....................................................... 2682Fila non resorbilia sterilia ............................................... 9.5-5603Fila non resorbilia sterilia in fuso ad usum veterinarium .. 1222Fila resorbilia synthetica monofilamenta sterilia................. 1213Fila resorbilia synthetica torta sterilia .................................. 1212Filgrastimi solutio concentrata........................................ 9.3-4899Filipendulae ulmariae herba .................................................. 1436Filum bombycis tortum sterile in fuso ad usumveterinarium .......................................................................... 1221

Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ................................................................... 9.5-5609

Filum lini sterile in fuso ad usum veterinarium .................. 1220Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ................................................................... 9.5-5609

Filum polyamidicum-6 sterile in fuso ad usumveterinarium ................................................................... 9.5-5609

Finasteridum............................................................................ 2473Fingolimodi hydrochloridum .......................................... 9.7-6616Fipronilum ad usum veterinarium................................. 9.5-5661Flavoxati hydrochloridum ...................................................... 2476Flecainidi acetas ...................................................................... 2478Flubendazolum ........................................................................ 2479Flucloxacillinum magnesicum octahydricum....................... 2480Flucloxacillinum natricum ..................................................... 2482Fluconazolum .......................................................................... 2484Flucytosinum ........................................................................... 2485Fludarabini phosphas ............................................................. 2487Fludeoxyglucosi (18F) solutio iniectabilis............................... 1135Fludrocortisoni acetas............................................................. 2489Flumazenili (N-[11C]methyl) solutio iniectabilis .................. 1137Flumazenilum.......................................................................... 2490Flumequinum .......................................................................... 2492Flumetasoni pivalas ................................................................ 2493Flunarizini dihydrochloridum ............................................... 2494Flunitrazepamum.................................................................... 2495Flunixini megluminum ad usum veterinarium ................... 2496Fluocinoloni acetonidum........................................................ 2497Fluocortoloni pivalas .............................................................. 2500Fluoresceinum ......................................................................... 2501Fluoresceinum natricum......................................................... 2502Fluoridi (18F) solutio ad radio-signandum ........................... 1139Fluorocholini (18F) solutio iniectabilis ............................ 9.7-6532Fluorodopae (18F) ab electrophila substitutione solutioiniectabilis .............................................................................. 1141

Fluorodopae (18F) ab nucleophila substitutione solutioiniectabilis ....................................................................... 9.7-6534

Fluoroethyl-L-tyrosini (18F) solutio iniectabilis.............. 9.3-4797Fluoromisonidazoli (18F) solutio iniectabilis......................... 1146Fluorouracilum................................................................. 9.2-4545Fluoxetini hydrochloridum .................................................... 2505

Flupentixoli dihydrochloridum .............................................. 2507Fluphenazini decanoas ........................................................... 2509Fluphenazini dihydrochloridum ............................................ 2510Fluphenazini enantas ............................................................. 2512Flurazepami monohydrochloridum ...................................... 2513Flurbiprofenum ....................................................................... 2514Fluspirilenum .......................................................................... 2516Flutamidum ............................................................................. 2517Fluticasoni propionas.............................................................. 2518Flutrimazolum......................................................................... 2520Fluvastatinum natricum......................................................... 2521Fluvoxamini maleas................................................................ 2523Foeniculi amari fructus .......................................................... 1352Foeniculi amari fructus aetheroleum .................................... 1279Foeniculi amari herbae aetheroleum .................................... 1280Foeniculi dulcis fructus ........................................................... 1353Follitropini solutio concentrata....................................... 9.6-6092Follitropinum.................................................................... 9.6-6087Formaldehydi solutio (35 per centum) .................................. 2537Formoteroli fumaras dihydricus ............................................ 2537Foscarnetum natricum hexahydricum ........................... 9.2-4546Fosfomycinum calcicum ......................................................... 2541Fosfomycinum natricum ........................................................ 2542Fosfomycinum trometamolum............................................... 2543Fosinoprilum natricum........................................................... 2544Fragmenta epithelii phaneraeque bestiarum ad productaallergenica .............................................................................. 1736

Framycetini sulfas ................................................................... 2547Frangulae cortex...................................................................... 1358Frangulae corticis extractum siccum normatum ................. 1359Fraxini folium.......................................................................... 1257Fraxini rhynchophyllae cortex ............................................... 1360Fructosum ................................................................................ 2548Fucus vel Ascophyllum............................................................ 1405Fulvestrantum ......................................................................... 2549Fumariae herba ................................................................ 9.2-4465Furosemidum.................................................................... 9.4-5377

GGabapentinum.................................................................. 9.4-5381Gadobutrolum monohydricum....................................... 9.3-4905Gadodiamidum hydricum............................................... 9.1-4165Galactosum .............................................................................. 2562Galantamini hydrobromidum ........................................ 9.6-6101Gallii (67Ga) citratis solutio iniectabilis................................. 1148Gallii (68Ga) chloridi solutio ad radio-signandum............... 1148Gallii (68Ga) edotreotidi solutio iniectabilis ................... 9.6-5979Gammadexum .................................................................. 9.4-5382Ganciclovirum ......................................................................... 2566Gardeniae fructus.................................................................... 1299Gastrodiae rhizoma.......................................................... 9.6-5993Gefitinibum....................................................................... 9.3-4906Gelatina ............................................................................. 9.3-4907Gemcitabini hydrochloridum ................................................. 2570Gemfibrozilum.................................................................. 9.5-5679Gentamicini sulfas................................................................... 2573Gentianae radix....................................................................... 1365Gentianae tinctura .................................................................. 1366Gestodenum ............................................................................. 2575Ginkgonis extractum siccum raffinatum et quantificatum .. 1368Ginkgonis folium ..................................................................... 1370Ginseng extractum siccum...................................................... 1374Ginseng radix........................................................................... 1372Glibenclamidum ...................................................................... 2577Gliclazidum.............................................................................. 2578Glimepiridum .......................................................................... 2580Glipizidum ........................................................................ 9.7-6621Glossa ................................................................................ 9.2-4423Glucagonum humanum.......................................................... 2584Glucosamini hydrochloridum ......................................... 9.5-5680Glucosamini sulfas kalii chloridum ................................ 9.5-5681Glucosamini sulfas natrii chloridum.............................. 9.5-5682



Glucosum .......................................................................... 9.1-4167Glucosum liquidum................................................................. 2590Glucosum liquidum dispersione desiccatum......................... 2591Glucosum monohydricum ............................................... 9.1-4168Glutathionum .......................................................................... 2594Glycerol-formalum .................................................................. 2600Glyceroli dibehenas ................................................................. 2598Glyceroli distearas ................................................................... 2599Glyceroli monocaprylas .......................................................... 2601Glyceroli monocaprylocapras ................................................. 2602Glyceroli monolinoleas .......................................................... 2603Glyceroli mono-oleas............................................................... 2604Glyceroli monostearas 40-55 ........................................... 9.2-4551Glyceroli trinitratis solutio ..................................................... 2606Glycerolum (85 per centum) ........................................... 9.6-6104Glycerolum ........................................................................ 9.6-6103Glycinum.................................................................................. 2608Glycopyrronii bromidum........................................................ 2609Gonadorelini acetas ......................................................... 9.4-5383Gonadotrophinum chorionicum ..................................... 9.4-5385Gonadotropinum sericum equinum ad usumveterinarium .......................................................................... 2613

Goserelinum ...................................................................... 9.6-6106Gossypii oleum hydrogenatum............................................... 2173Gramicidinum ......................................................................... 2616Graminis rhizoma ................................................................... 1331Granisetroni hydrochloridum ......................................... 9.6-6108Granula ad praeparationes homoeopathicas ........................ 1586Granula homoeopathica imbuta..................................... 9.1-4118Granula homoeopathica velata .............................................. 1587Granulata .......................................................................... 9.6-5913Griseofulvinum ................................................................. 9.7-6623Guaiacolum ............................................................................. 2620Guaifenesinum.................................................................. 9.6-6110Guanethidini monosulfas ....................................................... 2623Guaranae semen............................................................... 9.4-5306Guar galactomannanum ........................................................ 2623

HHalofantrini hydrochloridum ................................................ 2633Haloperidoli decanoas ............................................................ 2636Haloperidolum ........................................................................ 2634Halothanum............................................................................. 2637Hamamelidis cortex ................................................................ 1382Hamamelidis folium ............................................................... 1383Harpagophyti extractum siccum............................................ 1334Harpagophyti radix.......................................................... 9.6-5988Hederae folium ........................................................................ 1401Hedera helix ad praeparationes homoeopathicas ................ 1602Helianthi annui oleum raffinatum........................................ 3701Helium...................................................................................... 2642Heparina massae molecularis minoris.................................. 2646Heparinum calcicum ....................................................... 9.3-4911Heparinum natricum....................................................... 9.3-4913Heptaminoli hydrochloridum ................................................ 2649Hexamidini diisetionas ........................................................... 2650Hexetidinum ............................................................................ 2651Hexylresorcinolum .................................................................. 2652Hibisci sabdariffae flos ............................................................ 1498Hippocastani semen ................................................................ 1389Hippocastani seminis extractum siccum normatum............ 1390Histamini dihydrochloridum ................................................. 2653Histaminum ad praeparationes homoeopathicas.......... 9.1-4118Histidini hydrochloridum monohydricum............................ 2655Histidinum ............................................................................... 2654Homatropini hydrobromidum ............................................... 2657Homatropini methylbromidum ............................................. 2658Houttuyniae herba ........................................................... 9.4-5307Hyaluronidasum ..................................................................... 2702Hydralazini hydrochloridum .......................................... 9.2-4557Hydrargyri dichloridum ......................................................... 3003Hydrastis canadensis ad praeparationes homoeopathicas .. 1603

Hydrastis rhizoma ................................................................... 1378Hydrochlorothiazidum ........................................................... 2705Hydrocodoni hydrogenotartras 2.5-hydricus ....................... 2706Hydrocortisoni acetas ............................................................. 2711Hydrocortisoni hydrogenosuccinas........................................ 2713Hydrocortisonum .................................................................... 2708Hydrogenii peroxidum 30 per centum .................................. 2715Hydrogenii peroxidum 3 per centum .................................... 2715Hydromorphoni hydrochloridum .......................................... 2716Hydroxocobalamini acetas ..................................................... 2717Hydroxocobalamini chloridum.............................................. 2718Hydroxocobalamini sulfas...................................................... 2719Hydroxycarbamidum.............................................................. 2720Hydroxychloroquini sulfas .............................................. 9.3-4922Hydroxyethylcellulosum .................................................. 9.3-4924Hydroxyethylis salicylas.......................................................... 2723Hydroxypropylbetadexum ...................................................... 2725Hydroxypropylcellulosum....................................................... 2727Hydroxypropylcellulosum substitutum humile ............. 9.5-5691Hydroxyzini hydrochloridum ......................................... 9.5-5693Hymecromonum...................................................................... 2731Hymenopteri venena ad producta allergenica ..................... 2732Hyoscini butylbromidum................................................. 9.6-6121Hyoscini hydrobromidum ...................................................... 2735Hyoscinum ............................................................................... 2733Hyoscyamini sulfas ................................................................. 2737Hyoscyamus niger ad praeparationes homoeopathicas ....... 1604Hyperici herba ......................................................................... 1526Hyperici herbae extractum siccum quantificatum............... 1527Hypericum perforatum ad praeparationeshomoeopathicas ..................................................................... 1605

Hypromellosi phthalas ............................................................ 2740Hypromellosum ................................................................9.6-6123

IIbuprofenum ..................................................................... 9.6-6129Ichthammolum ........................................................................ 2747Idoxuridinum .......................................................................... 2748Iecoris aselli domestici oleum ................................................. 2151Iecoris aselli oleum A .............................................................. 2155Iecoris aselli oleum B .............................................................. 2159Ifosfamidum............................................................................. 2749Imatinibi mesilas .............................................................. 9.6-6131Imidaclopridum ad usum veterinarium ........................ 9.6-6134Imipenemum monohydricum ......................................... 9.4-5391Imipramini hydrochloridum .................................................. 2754Immunoglobulinum anti-T lymphocytorum ex animali adusum humanum .................................................................... 1741

Immunoglobulinum humanum anti-D ................................ 2662Immunoglobulinum humanum anti-D ad usumintravenosum ......................................................................... 2663

Immunoglobulinum humanum hepatitidis A ...................... 2683Immunoglobulinum humanum hepatitidis B ...................... 2684Immunoglobulinum humanum hepatitidis B ad usumintravenosum ......................................................................... 2684

Immunoglobulinum humanum morbillicum ....................... 2685Immunoglobulinum humanum normale ad usumintramusculum ...................................................................... 2685

Immunoglobulinum humanum normale ad usumintravenosum ......................................................................... 2687

Immunoglobulinum humanum normale ad usumsubdermicum ......................................................................... 2689

Immunoglobulinum humanum rabicum.............................. 2696Immunoglobulinum humanum rubellae .............................. 2698Immunoglobulinum humanum tetanicum........................... 2698Immunoglobulinum humanum varicellae............................ 2700Immunoglobulinum humanum varicellae ad usumintravenosum ......................................................................... 2700

Immunosera ad usum veterinarium ....................................... 823Immunosera ex animale ad usum humanum ............... 9.6-5907Immunoserum botulinicum ................................................... 1115Immunoserum contra venena viperarum europaearum ..... 1119



Immunoserum diphthericum ................................................. 1115Immunoserum gangraenicum (Clostridium novyi) ............. 1116Immunoserum gangraenicum (Clostridium perfringens) ... 1117Immunoserum gangraenicum (Clostridium septicum) ....... 1118Immunoserum gangraenicum mixtum ................................. 1116Immunoserum tetanicum ad usum humanum .................... 1119Immunoserum tetanicum ad usum veterinarium ............... 1123Indapamidum .......................................................................... 2755Indii (111In) chloridi solutio .................................................... 1153Indii (111In) oxini solutio ........................................................ 1154Indii (111In) pentetatis solutio iniectabilis ............................. 1154Indinaviri sulfas ...................................................................... 2757Indometacinum ................................................................ 9.7-6631Infliximabum solutio concentrata .................................. 9.6-6135Inhalanda.......................................................................... 9.4-5288Insulini zinci amorphi suspensio iniectabilis ........................ 2779Insulini zinci cristallini suspensio iniectabilis ...................... 2779Insulini zinci suspensio iniectabilis........................................ 2778Insulinum aspartum ............................................................... 2762Insulinum biphasicum iniectabile ......................................... 2770Insulinum bovinum ......................................................... 9.3-4929Insulinum glarginum ....................................................... 9.5-5699Insulinum humanum.............................................................. 2768Insulinum isophanum biphasicum iniectabile ..................... 2770Insulinum isophanum iniectabile .......................................... 2771Insulinum lisprum................................................................... 2771Insulinum porcinum ........................................................ 9.3-4931Insulinum solubile iniectabile ................................................ 2771Interferoni alfa-2 solutio concentrata ................................... 2780Interferoni beta-1a solutio concentrata.......................... 9.5-5701Interferoni gamma-1b solutio concentrata ........................... 2785int-rac-α-Tocopherolum ......................................................... 3800int-rac-α-Tocopherylis acetas................................................. 3802Iobenguani (123I) solutio iniectabilis ...................................... 1155Iobenguani (131I) solutio iniectabilis ad usumdiagnosticum.......................................................................... 1156

Iobenguani (131I) solutio iniectabilis ad usumtherapeuticum........................................................................ 1157

Iobenguani sulfas ad radiopharmaceutica..................... 9.2-4435Iodinati (125I) humani albumini solutio iniectabilis ............ 1152Iodixanolum ............................................................................ 2788Iodomethylnorcholesteroli (131I) solutio iniectabilis ............. 1159Iodum ....................................................................................... 2788Iohexolum ................................................................................ 2791Iopamidolum ........................................................................... 2795Iopromidum ............................................................................. 2798Iotrolanum ............................................................................... 2801Ipecacuanhae extractum fluidum normatum ...................... 1395Ipecacuanhae pulvis normatus .............................................. 1395Ipecacuanhae radix ................................................................. 1397Ipecacuanhae tinctura normata ............................................ 1398Ipratropii bromidum........................................................ 9.6-6141Irbesartanum ........................................................................... 2807Irinotecani hydrochloridum trihydricum ...................... 9.3-4933Isatidis radix ..................................................................... 9.6-5995Isoconazoli nitras .................................................................... 2811Isoconazolum ........................................................................... 2810Isofluranum ............................................................................. 2813Isoleucinum.............................................................................. 2814Isomaltum ......................................................................... 9.4-5392Isoniazidum ...................................................................... 9.5-5703Isoprenalini hydrochloridum ................................................. 2817Isoprenalini sulfas ................................................................... 2818Isopropylis isostearas........................................................ 9.2-4563Isopropylis myristas................................................................. 2820Isopropylis palmitas ................................................................ 2821Isosorbidi dinitras dilutus....................................................... 2821Isosorbidi mononitras dilutus ................................................ 2823Isotretinoinum .................................................................. 9.5-5705Isoxsuprini hydrochloridum................................................... 2826Isradipinum ............................................................................. 2828Itraconazolum ......................................................................... 2829Ivermectinum........................................................................... 2832

JJosamycini propionas .............................................................. 2839Josamycinum ........................................................................... 2837Juniperi aetheroleum .............................................................. 1404Juniperi galbulus ..................................................................... 1404

KKalii acetas............................................................................... 3375Kalii bichromas ad praeparationes homoeopathicas ........... 1608Kalii bromidum ....................................................................... 3376Kalii carbonas .......................................................................... 3377Kalii chloridum ....................................................................... 3377Kalii citras ................................................................................ 3378Kalii clavulanas ....................................................................... 3378Kalii clavulanas dilutus .......................................................... 3381Kalii dihydrogenophosphas .................................................... 3382Kalii hydrogenoaspartas hemihydricus................................. 3383Kalii hydrogenocarbonas ........................................................ 3384Kalii hydrogenotartras............................................................ 3384Kalii hydroxidum ............................................................. 9.4-5430Kalii iodidum........................................................................... 3385Kalii metabisulfis..................................................................... 3386Kalii natrii tartras tetrahydricus ........................................... 3388Kalii nitras ............................................................................... 3386Kalii perchloras........................................................................ 3387Kalii permanganas .................................................................. 3388Kalii sorbas .............................................................................. 3389Kalii sulfas......................................................................... 9.6-6185Kanamycini monosulfas .................................................. 9.6-6146Kanamycini sulfas acidus ................................................ 9.6-6145Kaolinum ponderosum ........................................................... 2847Ketamini hydrochloridum ...................................................... 2847Ketoconazolum ........................................................................ 2849Ketoprofenum .......................................................................... 2851Ketorolacum trometamolum.................................................. 2853Ketotifeni hydrogenofumaras................................................. 2854Kryptonum (81mKr) ad inhalationem ................................... 1159

LLabetaloli hydrochloridum .............................................. 9.4-5397Lacca......................................................................................... 3547Lacosamidi praeparatio ad infusionem ......................... 9.7-6635Lacosamidi solutio peroralis ........................................... 9.7-6636Lacosamidum ................................................................... 9.5-5709Lactitolum monohydricum ............................................. 9.3-4939Lactosum ........................................................................... 9.3-4940Lactosum monohydricum................................................ 9.3-4942Lactulosum ....................................................................... 9.5-5710Lactulosum liquidum....................................................... 9.5-5712Lamivudinum .......................................................................... 2871Lamotriginum ......................................................................... 2873Lansoprazolum ................................................................. 9.3-4945Lanugo cellulosi absorbens ..................................................... 3915Lanugo gossypii absorbens...................................................... 2172Lauromacrogolum 400 ........................................................... 2876Lavandulae aetheroleum ................................................. 9.5-5615Lavandulae flos................................................................. 9.5-5614Leflunomidum ......................................................................... 2879Leonuri cardiacae herba ......................................................... 1444Letrozolum ............................................................................... 2880Leucinum ................................................................................. 2881Leuprorelinum ......................................................................... 2883Levamisoli hydrochloridum ................................................... 2886Levamisolum ad usum veterinarium .................................... 2885Levetiracetamum .............................................................. 9.4-5399Levistici radix .......................................................................... 1420Levocabastini hydrochloridum........................................ 9.3-4946Levocarnitinum ................................................................ 9.6-6149Levodopum .............................................................................. 2892Levodropropizinum................................................................. 2893Levomentholum ....................................................................... 2894Levomepromazini hydrochloridum ....................................... 2895



Levomepromazini maleas....................................................... 2896Levomethadoni hydrochloridum ........................................... 2897Levonorgestrelum .................................................................... 2899Levothyroxinum natricum ..................................................... 2902Lichen islandicus ..................................................................... 1392Lidocaini hydrochloridum monohydricum.................... 9.6-6150Lidocainum .............................................................................. 2903Ligustici chuanxiong rhizoma ......................................... 9.4-5314Ligustici radix et rhizoma................................................ 9.7-6550Limonis aetheroleum .............................................................. 1411Lincomycini hydrochloridum ................................................. 2906Lini oleum virginale ................................................................ 2908Lini semen ................................................................................ 1415Liothyroninum natricum ....................................................... 2909Liquiritiae extractum siccum ad saporandum ..................... 1415Liquiritiae radix ...................................................................... 1416Lisinoprilum dihydricum........................................................ 2910Lithii carbonas ......................................................................... 2912Lithii citras ............................................................................... 2913L-Methionini ([11C]methyl) solutio iniectabilis .................... 1161Lobelini hydrochloridum ........................................................ 2913Lomustinum............................................................................. 2914Loperamidi hydrochloridum .................................................. 2915Loperamidi oxidum monohydricum ..................................... 2917Lopinavirum ............................................................................ 2918Loratadinum ............................................................................ 2922Lorazepamum.......................................................................... 2924Losartanum kalicum............................................................... 2925Lovastatinum ........................................................................... 2927Lufenuronum ad usum veterinarium ................................... 2929Lupuli flos ................................................................................ 1388Lutetii (177Lu) solutio ad radio-signandum ................... 9.3-4799Lycii fructus ...................................................................... 9.3-4812Lycopi herba...................................................................... 9.1-4105Lymecyclinum.......................................................................... 2930Lynestrenolum ......................................................................... 2932Lysini acetas............................................................................. 2933Lysini hydrochloridum............................................................ 2935Lythri herba ............................................................................. 1419

MMacrogol 20 glyceroli monostearas........................................ 2940Macrogol 40 sorbitoli heptaoleas ........................................... 2941Macrogol 6 glyceroli caprylocapras........................................ 2939Macrogola ................................................................................ 2950Macrogola massae molecularis magnae................................ 2952Macrogolglyceridorum caprylocaprates.......................... 9.1-4141Macrogolglyceridorum laurates ...................................... 9.1-4173Macrogolglyceridorum linoleates .................................... 9.1-4174Macrogolglyceridorum oleates......................................... 9.1-4185Macrogolglyceridorum stearates ..................................... 9.1-4206Macrogolglyceroli cocoates ..................................................... 2948Macrogolglyceroli hydroxystearas.......................................... 2949Macrogolglyceroli ricinoleas ................................................... 2950Macrogoli 15 hydroxystearas ................................................. 2939Macrogoli 30 dipolyhydroxystearas ....................................... 2941Macrogoli aether cetostearylicus ............................................ 2942Macrogoli aether isotridecylicus ............................................ 2943Macrogoli aether laurilicus .................................................... 2943Macrogoli aether oleicus ......................................................... 2945Macrogoli aether stearylicus................................................... 2947Macrogoli oleas ........................................................................ 2944Macrogoli stearas..................................................................... 2947Magaldratum ........................................................................... 2953Magnesii acetas tetrahydricus ................................................ 2954Magnesii aluminometasilicas .......................................... 9.7-6641Magnesii aspartas dihydricus.......................................... 9.3-4951Magnesii chloridum 4.5-hydricum ........................................ 2957Magnesii chloridum hexahydricum ....................................... 2957Magnesii citras ......................................................................... 2958Magnesii citras dodecahydricus ............................................. 2959Magnesii citras nonahydricus ................................................ 2959

Magnesii gluconas ................................................................... 2960Magnesii glycerophosphas....................................................... 2960Magnesii hydrogenophosphas trihydricus ad praeparationeshomoeopathicas ..................................................................... 1609

Magnesii hydroxidum ............................................................. 2961Magnesii lactas dihydricus ..................................................... 2961Magnesii oxidum leve ............................................................. 2963Magnesii oxidum ponderosum............................................... 2962Magnesii peroxidum................................................................ 2963Magnesii pidolas ...................................................................... 2964Magnesii stearas ...................................................................... 2965Magnesii subcarbonas levis .................................................... 2956Magnesii subcarbonas ponderosus......................................... 2955Magnesii sulfas heptahydricus ............................................... 2968Magnesii trisilicas .................................................................... 2968Magnesium fluoratumad praeparationes homoeopathicas .. 1609Magnoliae biondii flos immaturus ................................. 9.3-4817Magnoliae officinalis cortex ............................................ 9.2-4467Magnoliae officinalis flos ................................................. 9.3-4819Malathionum ........................................................................... 2970Maltitolum ............................................................................... 2973Maltitolum liquidum .............................................................. 2974Maltodextrinum ...................................................................... 2975Malvae folium.......................................................................... 1425Malvae sylvestris flos ............................................................... 1424Mangani gluconas ................................................................... 2976Mangani glycerophosphas hydricus....................................... 2976Mangani sulfas monohydricus ........................................ 9.2-4567Mannitolum ...................................................................... 9.2-4567Maprotilini hydrochloridum .................................................. 2980Marbofloxacinum ad usum veterinarium ............................ 2981Marrubii herba ................................................................. 9.6-6001Masticabilia gummis medicata ....................................... 9.3-4784Mastix....................................................................................... 1430Mate folium ...................................................................... 9.4-5309Matricariae aetheroleum ........................................................ 1434Matricariae extractum fluidum ............................................. 1433Matricariae flos ....................................................................... 1431Maydis amylum....................................................................... 2969Maydis oleum raffinatum ....................................................... 2969Mebendazolum ........................................................................ 2983Meclozini dihydrochloridum ........................................... 9.4-5403Medroxyprogesteroni acetas ................................................... 2985Mefloquini hydrochloridum ................................................... 2989Megestroli acetas ..................................................................... 2990Megluminum ........................................................................... 2992Mel ............................................................................................ 2659Melaleucae aetheroleum ......................................................... 1536Meldonium dihydricum.......................................................... 2993Meliloti herba .......................................................................... 1437Melissae folii extractum siccum ............................................. 1439Melissae folium........................................................................ 1438Meloxicamum .......................................................................... 2994Melphalanum .......................................................................... 2996Menadionum ........................................................................... 2998Menthae arvensis aetheroleum partim mentholumdepletum................................................................................. 1443

Menthae piperitae aetheroleum ...................................... 9.7-6552Menthae piperitae folii extractum siccum ..................... 9.2-4471Menthae piperitae folium ................................................ 9.2-4469Mentholum racemicum .......................................................... 2998Menyanthidis trifoliatae folium ............................................. 1291Mepivacaini hydrochloridum.......................................... 9.6-6155Meprobamatum....................................................................... 3001Mepyramini maleas ................................................................ 3001Mercaptopurinum ................................................................... 3003Meropenemum trihydricum................................................... 3004Mesalazinum .................................................................... 9.6-6156Mesnum............................................................................. 9.2-4569Mesterolonum .......................................................................... 3009Mestranolum............................................................................ 3010Metacresolum .......................................................................... 3011Metamizolum natricum monohydricum .............................. 3012



Metformini hydrochloridum .................................................. 3014Methadoni hydrochloridum ................................................... 3020Methanolum ............................................................................ 3022Methanum ............................................................................... 3021Methanum (2 per centum) in nitrogenio intermixtum .. 9.3-4953Methenaminum ....................................................................... 3023Methioninum ........................................................................... 3024Methotrexatum........................................................................ 3026Methylcellulosum ............................................................. 9.6-6160Methyldopum .......................................................................... 3033Methyleni chloridum............................................................... 3034Methylergometrini maleas...................................................... 3035Methylhydroxyethylcellulosum .............................................. 3037Methylis nicotinas ................................................................... 3028Methylis parahydroxybenzoas ............................................... 3029Methylis parahydroxybenzoas natricus................................. 3591Methylis salicylas..................................................................... 3030Methylphenidati hydrochloridum.......................................... 3037Methylphenobarbitalum ......................................................... 3039Methylprednisoloni acetas ............................................... 9.4-5404Methylprednisoloni hydrogenosuccinas ................................ 3044Methylprednisolonum ............................................................. 3040Methylrosanilinii chloridum ........................................... 9.4-5406Methyltestosteronum............................................................... 3048Methylthioninii chloridum ..................................................... 3049Metixeni hydrochloridum....................................................... 3050Metoclopramidi hydrochloridum monohydricum ........ 9.4-5409Metoclopramidum............................................................ 9.4-5407Metolazonum........................................................................... 3053Metoprololi succinas ............................................................... 3055Metoprololi tartras .................................................................. 3056Metrifonatum .......................................................................... 3058Metronidazoli benzoas............................................................ 3060Metronidazolum...................................................................... 3059Mexiletini hydrochloridum .................................................... 3062Mianserini hydrochloridum ................................................... 3063Miconazoli nitras ............................................................. 9.7-6643Miconazolum .................................................................... 9.7-6642Midazolamum ......................................................................... 3069Milbemycinum oximum ad usum veterinarium ........... 9.6-6162Millefolii herba ........................................................................ 1564Minocyclini hydrochloridum dihydricum ...................... 9.2-4573Minoxidilum ............................................................................ 3072Mirtazapinum ......................................................................... 3074Misoprostolum ......................................................................... 3075Mitomycinum .......................................................................... 3078Mitoxantroni hydrochloridum............................................... 3079Modafinilum ............................................................................ 3081Molgramostimi solutio concentrata................................ 9.5-5719Molsidominum ........................................................................ 3084Mometasoni furoas .......................................................... 9.5-5721Mometasoni furoas monohydricus ................................. 9.5-5724Montelukastum natricum ............................................... 9.1-4179Moranteli hydrogenotartras ad usum veterinarium............ 3090Morphini hydrochloridum ..................................................... 3091Morphini sulfas ....................................................................... 3093Moutan cortex .................................................................. 9.4-5311Moxidectinum ad usum veterinarium .................................. 3095Moxifloxacini hydrochloridum .............................................. 3098Moxonidinum .......................................................................... 3100Mucores ad producta allergenica........................................... 3094Mupirocinum.................................................................... 9.7-6645Mupirocinum calcicum.................................................... 9.7-6647Musci medicati .......................................................................... 859Mycophenolas mofetil ............................................................. 3104Mycophenolatum natricum.................................................... 3105myo-Inositolum ....................................................................... 2761Myristicae fragrantis aetheroleum......................................... 1455Myrrha .............................................................................. 9.2-4468Myrrhae tinctura .............................................................. 9.2-4469Myrtilli fructus recens ...................................................... 9.6-5987Myrtilli fructus recentis extractum siccum raffinatum etnormatum ....................................................................... 9.7-6547

Myrtilli fructus siccus....................................................... 9.6-5986

NNabumetonum......................................................................... 3109N-Acetyltryptophanum ........................................................... 1639N-Acetyltyrosinum .................................................................. 1641Nadololum ............................................................................... 3110Nadroparinum calcicum ................................................. 9.5-5731Naftidrofuryli hydrogenooxalas ............................................. 3113Naloxoni hydrochloridum dihydricum .......................... 9.3-4957Naltrexoni hydrochloridum ................................................... 3118Nandroloni decanoas .............................................................. 3120Naphazolini hydrochloridum ................................................. 3122Naphazolini nitras .................................................................. 3123Naproxenum ............................................................................ 3124Naproxenum natricum ........................................................... 3126Nasalia ....................................................................................... 866Nateglinidum ........................................................................... 3128Natrii acetas trihydricus ......................................................... 3558Natrii acetatis ([1-11C]) solutio iniectabilis........................... 1166Natrii alendronas trihydricus ................................................ 3559Natrii alginas ........................................................................... 3560Natrii amidotrizoas................................................................. 3561Natrii aminosalicylas dihydricus ........................................... 3562Natrii ascorbas......................................................................... 3563Natrii aurothiomalas .............................................................. 3565Natrii benzoas.......................................................................... 3566Natrii bromidum ..................................................................... 3567Natrii calcii edetas................................................................... 3568Natrii calcii pentetas ad radiopharmaceutica ............... 9.3-4800Natrii caprylas ......................................................................... 3569Natrii carbonas ........................................................................ 3570Natrii carbonas decahydricus................................................. 3570Natrii carbonas monohydricus .............................................. 3571Natrii cetylo- et stearylosulfas ......................................... 9.4-5443Natrii chloridum ..................................................................... 3573Natrii chromatis (51Cr) solutio sterilis ................................... 1167Natrii citras .............................................................................. 3574Natrii cromoglicas ................................................................... 3574Natrii cyclamas........................................................................ 3576Natrii dihydrogenophosphas dihydricus ............................... 3577Natrii docusas .......................................................................... 2309Natrii fluoridi (18F) solutio iniectabilis.................................. 1168Natrii fluoridum ...................................................................... 3579Natrii fusidas ........................................................................... 3579Natrii glycerophosphas hydricus ............................................ 3582Natrii hyaluronas .................................................................... 3583Natrii hydrogenocarbonas ...................................................... 3585Natrii hydroxidum .................................................................. 3585Natrii iodidi (123I) solutioad radio-signandum..................... 1170Natrii iodidi (123I) solutio iniectabilis .................................... 1169Natrii iodidi (131I) capsulae ad usum diagnosticum............. 1170Natrii iodidi (131I) capsulae ad usum therapeuticum........... 1171Natrii iodidi (131I) solutio........................................................ 1172Natrii iodidi (131I) solutio ad radio-signandum.................... 1173Natrii iodidum......................................................................... 3586Natrii iodohippuras dihydricus ad radiopharmaceutica ...... 9.2-4438

Natrii iodohippurati (123I) solutio iniectabilis....................... 1175Natrii iodohippurati (131I) solutio iniectabilis....................... 1176Natrii lactatis solutio .............................................................. 3586Natrii laurilsulfas ............................................................. 9.1-4200Natrii lauroylsarcosinas ad usum externum ........................ 3589Natrii metabisulfis................................................................... 3591Natrii molybdas dihydricus ............................................. 9.7-6682Natrii molybdatis (99Mo) fissione formati solutio ................ 1176Natrii nitris .............................................................................. 3593Natrii nitroprussias ................................................................. 3593Natrii perboras hydricus ......................................................... 3594Natrii pertechnetatis (99mTc) acceleratore formati solutioiniectabilis ....................................................................... 9.3-4801



Natrii pertechnetatis (99mTc) fissione formati solutioiniectabilis .............................................................................. 1178

Natrii pertechnetatis (99mTc) sine fissione formati solutioiniectabilis .............................................................................. 1180

Natrii phenylbutyras ............................................................... 3595Natrii phosphatis (32P) solutio iniectabilis ............................ 1180Natrii picosulfas....................................................................... 3596Natrii polystyrenesulfonas ...................................................... 3597Natrii propionas ...................................................................... 3598Natrii pyrophosphas decahydricus ad radiopharmaceutica.. 9.2-4439

Natrii risedronas 2.5-hydricus ............................................... 3495Natrii salicylas ......................................................................... 3601Natrii selenis ............................................................................ 3601Natrii selenis pentahydricus ................................................... 3602Natrii (S)-lactatis solutio ........................................................ 3587Natrii stearas ........................................................................... 3605Natrii stearylis fumaras .......................................................... 3606Natrii sulfas anhydricus .................................................. 9.6-6207Natrii sulfas decahydricus ............................................... 9.6-6207Natrii sulfis .............................................................................. 3608Natrii sulfis heptahydricus ..................................................... 3608Natrii tetrachloroauras dihydricus ad praeparationeshomoeopathicas .............................................................. 9.5-5623

Natrii thiosulfas ....................................................................... 3609Natrii valproas......................................................................... 3609Neohesperidin-dihydrochalconum......................................... 3130Neomycini sulfas ..................................................................... 3132Neostigmini bromidum........................................................... 3134Neostigmini metilsulfas.................................................... 9.5-5733Neroli aetheroleum.................................................................. 1449Netilmicini sulfas.............................................................. 9.2-4579Nevirapinum..................................................................... 9.3-4959Nevirapinum hemihydricum.................................................. 3139Niaouli typo cineolo aetheroleum .......................................... 1453Nicardipini hydrochloridum ........................................... 9.3-4960Nicergolinum .................................................................... 9.7-6651Nicethamidum ......................................................................... 3155Niclosamidum.......................................................................... 3142Niclosamidum monohydricum .............................................. 3143Nicorandilum........................................................................... 3144Nicotinamidum ....................................................................... 3145Nicotini ditartras dihydricus .................................................. 3147Nicotini resinas ........................................................................ 3148Nicotinum ................................................................................ 3146Nifedipinum ............................................................................. 3151Nifuroxazidum ........................................................................ 3154Nilutamidum ........................................................................... 3156Nimesulidum ........................................................................... 3157Nimodipinum .......................................................................... 3158Nitrazepamum......................................................................... 3159Nitrendipinum ......................................................................... 3160Nitrofuralum............................................................................ 3163Nitrofurantoinum.................................................................... 3164Nitrogenii oxidum ................................................................... 3162Nitrogenium............................................................................. 3165Nitrogenium oxygenio depletum............................................ 3166Nizatidinum............................................................................. 3167N-Methylpyrrolidonum .......................................................... 3046Nomegestroli acetas................................................................. 3169Nonoxinolum 9........................................................................ 3170Noradrenalini hydrochloridum ...................................... 9.3-4962Noradrenalini tartras ...................................................... 9.3-4964Norethisteroni acetas .............................................................. 3175Norethisteronum ..................................................................... 3174Norfloxacinum ................................................................. 9.7-6653Norfluranum............................................................................ 3179Norgestimatum ........................................................................ 3184Norgestrelum ........................................................................... 3185Nortriptylini hydrochloridum ......................................... 9.7-6654Noscapini hydrochloridum hydricum ................................... 3188Noscapinum ............................................................................. 3187Notoginseng radix ................................................................... 1454

Nystatinum ....................................................................... 9.6-6167

OOctoxinolum 10 ....................................................................... 3193Octyldodecanolum ........................................................... 9.4-5421Octylis gallas ............................................................................ 3193Oenotherae oleum raffinatum................................................ 2444Ofloxacinum ............................................................................ 3195Olanzapinum........................................................................... 3196Oleae folii extractum siccum .................................................. 1458Oleae folium............................................................................. 1456Olea herbaria ............................................................................ 848Olibanum indicum.................................................................. 1392Olivae oleum raffinatum ................................................. 9.3-4973Olivae oleum virginale..................................................... 9.3-4973Olmesartanum medoxomilum............................................... 3201Olsalazinum natricum............................................................ 3203Omega-3 acidorum esteri ethylici 60..................................... 3205Omega-3 acidorum esteri ethylici 90.............................. 9.2-4583Omega-3 acidorum triglycerida ............................................. 3209Omeprazolum .......................................................................... 3211Omeprazolum magnesicum.................................................... 3213Omeprazolum natricum ......................................................... 3214Ondansetroni hydrochloridum dihydricum ......................... 3216Ononidis radix......................................................................... 1493Ophthalmica .............................................................................. 857Opii extractum siccum normatum ........................................ 1459Opii pulvis normatus .............................................................. 1460Opii tinctura normata ............................................................ 1463Opium crudum ........................................................................ 1461Orbifloxacinum ad usum veterinarium ................................ 3217Orciprenalini sulfas................................................................. 3219Origani herba .......................................................................... 1464Orphenadrini citras ................................................................ 3220Orphenadrini hydrochloridum .............................................. 3222Orthosiphonis folium .............................................................. 1402Oryzae amylum ....................................................................... 3487Oseltamiviri phosphas ..................................................... 9.2-4585Ouabainum .............................................................................. 3225Oxacillinum natricum monohydricum ................................. 3226Oxaliplatinum ......................................................................... 3228Oxazepamum .......................................................................... 3231Oxcarbazepinum ..................................................................... 3232Oxeladini hydrogenocitras ..................................................... 3234Oxfendazolum ad usum veterinarium .................................. 3235Oxitropii bromidum................................................................ 3236Oxybuprocaini hydrochloridum ............................................ 3239Oxybutynini hydrochloridum ................................................ 3241Oxycodoni hydrochloridum ................................................... 3242Oxygenium............................................................................... 3243Oxygenium (15O) ..................................................................... 1163Oxygenium 93 per centum ..................................................... 3244Oxymetazolini hydrochloridum............................................. 3245Oxytetracyclini hydrochloridum ............................................ 3249Oxytetracyclinum dihydricum ............................................... 3247Oxytocini solutio concentrata ................................................ 3251Oxytocinum ............................................................................. 3250

PPaclitaxelum ..................................................................... 9.7-6659Paeoniae radix alba ................................................................ 1472Paeoniae radix rubra .............................................................. 1471Pancreatis pulvis...................................................................... 3260Pancuronii bromidum ............................................................ 3263Pantoprazolum natricum sesquihydricum .................... 9.6-6171Papaverini hydrochloridum ................................................... 3265Papaveris rhoeados flos........................................................... 1492Paracetamolum ................................................................ 9.4-5429Paraffinum liquidum ....................................................... 9.5-5737Paraffinum perliquidum.................................................. 9.5-5737Paraffinum solidum ................................................................ 3268Paraldehydum ......................................................................... 3271



Parenteralia ............................................................................... 871Parnaparinum natricum ........................................................ 3272Paroxetini hydrochloridum .................................................... 3272Paroxetini hydrochloridum hemihydricum .......................... 3275Passiflorae herba...................................................................... 1469Passiflorae herbae extractum siccum..................................... 1470Pefloxacini mesilas dihydricus ............................................... 3277Pelargonii radix ....................................................................... 1470Pemetrexedum dinatricum heptahydricum.......................... 3279Penbutololi sulfas .................................................................... 3281Penicillaminum ....................................................................... 3282Pentaerythrityli tetranitras dilutus........................................ 3284Pentamidini diisetionas .......................................................... 3286Pentazocini hydrochloridum .................................................. 3287Pentazocini lactas.................................................................... 3288Pentazocinum .......................................................................... 3287Pentobarbitalum .............................................................. 9.6-6172Pentobarbitalum natricum.............................................. 9.6-6174Pentoxifyllinum ....................................................................... 3290Pentoxyverini hydrogenocitras............................................... 3292Pepsini pulvis ........................................................................... 3293Pergolidi mesilas ...................................................................... 3295Permethrinum 25:75 ............................................................... 3301Perphenazinum ....................................................................... 3303Persicariae tinctoriae folium .................................................. 1393Pethidini hydrochloridum ...................................................... 3304Petroleum ad praeparationes homoeopathicas..................... 1612Pharmaceutica .................................................................. 9.7-6523Phenazonum ............................................................................ 3305Pheniramini maleas ................................................................ 3306Phenobarbitalum..................................................................... 3307Phenobarbitalum natricum.................................................... 3309Phenolphthaleinum ................................................................. 3311Phenolsulfonphthaleinum....................................................... 3311Phenolum ................................................................................. 3310Phenoxyethanolum ................................................................. 3312Phenoxymethylpenicillinum ............................................ 9.1-4189Phenoxymethylpenicillinum kalicum ............................. 9.1-4190Phentolamini mesilas.............................................................. 3317Phenylalaninum ...................................................................... 3318Phenylbutazonum ................................................................... 3319Phenylephrini hydrochloridum .............................................. 3322Phenylephrinum ...................................................................... 3321Phenylhydrargyri acetas ......................................................... 3324Phenylhydrargyri boras .......................................................... 3324Phenylhydrargyri nitras.......................................................... 3325Phenylpropanolamini hydrochloridum................................. 3325Phenytoinum .................................................................... 9.6-6179Phenytoinum natricum.................................................... 9.6-6180Phloroglucinolum ............................................................. 9.7-6663Phloroglucinolum dihydricum ........................................ 9.7-6665Pholcodinum monohydricum ......................................... 9.1-4192Phospholipida ex ovo ad iniectabile ............................... 9.2-4533Phospholipida ex soia ad iniectabile .............................. 9.4-5445Phthalylsulfathiazolum ........................................................... 3334Physostigmini salicylas ........................................................... 3335Phytomenadionum racemicum....................................... 9.6-6182Phytosterolum.......................................................................... 3337Picotamidum monohydricum ................................................ 3338Pilocarpini hydrochloridum ................................................... 3339Pilocarpini nitras..................................................................... 3340Pimobendanum ad usum veterinarium......................... 9.5-5738Pimozidum............................................................................... 3343Pindololum .............................................................................. 3344Pini pumilionis aetheroleum .................................................. 1340Pini sylvestris aetheroleum ..................................................... 1480Pioglitazoni hydrochloridum ................................................. 3345Piperacillinum ........................................................................ 3347Piperacillinum natricum ........................................................ 3349Piperazini adipas..................................................................... 3351Piperazini citras....................................................................... 3352Piperazinum hydricum ........................................................... 3352Piperis fructus .......................................................................... 1474

Piperis longi fructus ................................................................ 1417Piracetamum ........................................................................... 3353Pirenzepini dihydrochloridum monohydricum.................... 3354Piretanidum ............................................................................. 3356Pirfenidonum........................................................................... 3357Piroxicamum ........................................................................... 3358Piscis oleum omega-3 acidis abundans ................................. 2474Pisi amylum ............................................................................. 3277Pivampicillinum ...................................................................... 3359Pivmecillinami hydrochloridum ........................................... 3361Plantae ad ptisanam ................................................................. 820Plantae medicinales ......................................................... 9.2-4419Plantae medicinales ad praeparationes homoeopathicas .... 1570Plantae medicinales praeparatae ............................................. 819Plantaginis lanceolatae folium............................................... 1497Plantaginis ovatae semen ....................................................... 1400Plantaginis ovatae seminis tegumentum............................... 1400Plantarum medicinalium extracta ................................. 9.7-6519Plasma humanum ad separationem ..................................... 2691Plasma humanum coagmentatum conditumque adexstinguendum virum .................................................... 9.2-4555

Platycodonis radix............................................................ 9.6-5999Podophyllotoxinum .......................................................... 9.6-6184Pollines ad producta allergenica ............................................ 3362Poloxamera .......................................................................9.7-6666Polyacrylatis dispersio 30 per centum ................................... 3365Poly(alcohol vinylicus)..................................................... 9.3-4979Polygalae radix ........................................................................ 1515Polygoni avicularis herba ....................................................... 1406Polygoni cuspidati rhizoma et radix...................................... 1481Polygoni multiflori radix ........................................................ 1356Polygoni orientalis fructus............................................... 9.2-4472Polymyxini B sulfas.......................................................... 9.7-6668Polyoxypropyleni aether stearylicus ............................... 9.5-5739Polysorbatum 20...................................................................... 3368Polysorbatum 40...................................................................... 3369Polysorbatum 60...................................................................... 3370Polysorbatum 80............................................................... 9.2-4591Poly(vinylis acetas)........................................................... 9.3-4977Poly(vinylis acetas) dispersio 30 per centum ................. 9.3-4978Poria ......................................................................................... 1484Povidonum........................................................................ 9.2-4592Povidonum iodinatum............................................................ 3394Praeadmixta ad alimenta medicata ad usum veterinarium .. 875Praecursores chimici ad radiopharmaceutica......................... 813Praeparationes ad irrigationem ............................................... 880Praeparationes buccales ................................................... 9.3-4787Praeparationes celeres ad ptisanam ........................................ 820Praeparationes homoeopathicae ..................................... 9.1-4117Praeparationes insulini iniectabiles ....................................... 2776Praeparationes intramammariae ad usum veterinarium ..... 861Praeparationes intraruminales ....................................... 9.3-4785Praeparationes intra-uterinae ad usum veterinarium .......... 862Praeparationes liquidae ad usum dermicum.......................... 864Praeparationes liquidae peroraliae................................. 9.3-4785Praeparationes liquidae veterinariae ad usum dermicum......................................................................................... 9.3-4792

Praeparationes molles ad usum dermicum............................. 882Praeparationes molles veterinariae peroraliae ....................... 890Praeparationes pharmaceuticae in vasis cum pressu .... 9.6-5914Pramipexoli dihydrochloridum monohydricum .................. 3394Pravastatinum natricum ........................................................ 3396Prazepamum............................................................................ 3397Praziquantelum ....................................................................... 3398Prazosini hydrochloridum ...................................................... 3400Prednicarbatum....................................................................... 3401Prednisoloni acetas.................................................................. 3404Prednisoloni natrii phosphas ................................................. 3407Prednisoloni pivalas ................................................................ 3406Prednisolonum ........................................................................ 3403Prednisonum..................................................................... 9.3-4980Pregabalinum ...................................................................9.2-4595Prilocaini hydrochloridum .............................................. 9.4-5432



Prilocainum ...................................................................... 9.4-5431Primaquini diphosphas.................................................... 9.6-6185Primidonum ..................................................................... 9.3-4982Primulae radix......................................................................... 1485Probenecidum .......................................................................... 3417Procainamidi hydrochloridum............................................... 3418Procaini hydrochloridum ....................................................... 3419Prochlorperazini maleas ......................................................... 3420Producta ab arte ADN recombinandorum .................... 9.7-6526Producta ab fermentatione .............................................. 9.6-5909Producta allergenica ........................................................ 9.6-5905Producta biotherapeutica viva ad usum humanum ..... 9.7-6522Producta cum possibili transmissione vectoriumenkephalopathiarum spongiformium animalium................ 832

Progesteronum ......................................................................... 3420Proguanili hydrochloridum ............................................. 9.7-6669Prolinum .................................................................................. 3424Promazini hydrochloridum .................................................... 3425Promethazini hydrochloridum............................................... 3426Propacetamoli hydrochloridum ............................................. 3427Propafenoni hydrochloridum ................................................. 3428Propanolum ............................................................................. 3430Propanthelini bromidum........................................................ 3431Propofolum .............................................................................. 3432Propranololi hydrochloridum ................................................ 3434Propylenglycoli dicaprylocapras............................................. 3438Propylenglycoli dilauras .................................................. 9.2-4598Propylenglycoli monolauras ................................................... 3439Propylenglycoli monopalmitostearas..................................... 3440Propylenglycolum .................................................................... 3437Propylis gallas .......................................................................... 3435Propylis parahydroxybenzoas ................................................ 3436Propylis parahydroxybenzoas natricus ................................. 3599Propylthiouracilum ................................................................. 3441Propyphenazonum .................................................................. 3442Protamini sulfas ............................................................... 9.6-6187Prothrombinum multiplex humanum .................................. 2695Protirelinum ............................................................................ 3444Proxyphyllinum ....................................................................... 3445Prunellae spica......................................................................... 1327Pruni africanae cortex ............................................................ 1490Pseudoephedrini hydrochloridum ......................................... 3446Psyllii semen............................................................................. 1486Puerariae lobatae radix ................................................... 9.7-6549Puerariae thomsonii radix .............................................. 9.7-6555Pullulanum .............................................................................. 3447Pulveres ad usum dermicum .................................................... 874Pulveres perorales ...................................................................... 874Pyranteli embonas................................................................... 3448Pyrazinamidum....................................................................... 3449Pyridostigmini bromidum ...................................................... 3450Pyridoxini hydrochloridum.................................................... 3451Pyrimethaminum ............................................................. 9.7-6671Pyrrolidonum .......................................................................... 3453

QQuercus cortex ......................................................................... 1456Quetiapini fumaras .......................................................... 9.6-6191Quillajae cortex ....................................................................... 1491Quinaprili hydrochloridum.................................................... 3459

RRabeprazolum natricum ......................................................... 3469Rabeprazolum natricum hydricum ....................................... 3470Racecadotrilum ....................................................................... 3472Raclopridi ([11C]methoxy) solutio iniectabilis ...................... 1165Radiopharmaceutica ................................................................. 832Raloxifeni hydrochloridum .................................................... 3473Raltegraviri compressi...................................................... 9.5-5744Raltegraviri compressi masticabiles ................................ 9.5-5743Raltegravirum kalicum .................................................... 9.4-5437Ramiprilum.............................................................................. 3475

Ranitidini hydrochloridum ............................................. 9.6-6197Rapae oleum raffinatum......................................................... 3479Ratanhiae radix ....................................................................... 1494Ratanhiae tinctura .................................................................. 1495Rectalia....................................................................................... 881Remifentanili hydrochloridum........................................ 9.2-4604Repaglinidum........................................................................... 3479Reserpinum .............................................................................. 3481Resorcinolum ........................................................................... 3481Rhamni purshianae cortex ..................................................... 1307Rhamni purshianae extractum siccum normatum .............. 1308Rhei radix................................................................................. 1496Rhenii sulfidi colloidalis et technetii (99mTc) solutioiniectabilis .............................................................................. 1183

Ribavirinum............................................................................. 3482Ribis nigri folium..................................................................... 1290Riboflavini natrii phosphas .................................................... 3485Riboflavinum ........................................................................... 3484Ricini oleum hydrogenatum ................................................... 1966Ricini oleum raffinatum .................................................. 9.7-6583Ricini oleum virginale............................................................. 1968Rifabutinum............................................................................. 3488Rifampicinum .......................................................................... 3489Rifamycinum natricum ................................................... 9.6-6198Rifaximinum............................................................................ 3492Rilmenidini dihydrogenophosphas ........................................ 3494Risperidonum .......................................................................... 3496Ritonavirum............................................................................. 3498Rivastigmini hydrogenotartras .............................................. 3503Rivastigminum ........................................................................ 3501Rizatriptani benzoas ............................................................... 3504Rocuronii bromidum .............................................................. 3506Ropiniroli hydrochloridum.............................................. 9.6-6200Ropivacaini hydrochloridum monohydricum ...................... 3509Rosae pseudo-fructus .............................................................. 1338Rosmarini aetheroleum .......................................................... 1500Rosmarini folium .................................................................... 1499Rosuvastatinum calcicum....................................................... 3511Rotigotinum ...................................................................... 9.6-6201Roxithromycinum ................................................................... 3513RRR-α-Tocopherolum ............................................................. 3801RRR-α-Tocopherylis acetas .................................................... 3804RRR-α-Tocopherylis hydrogenosuccinas ............................... 3808Rupatadini fumaras ......................................................... 9.3-4987Rusci rhizoma .......................................................................... 1296Rutosidum trihydricum .......................................................... 3516

SSabalis serrulatae extractum .................................................. 1509Sabalis serrulatae fructus................................................. 9.7-6553Sacchari monopalmitas .......................................................... 3665Saccharinum ..................................................................... 9.7-6675Saccharinum natricum .................................................... 9.7-6676Sacchari sphaerae .................................................................... 3670Sacchari stearas ....................................................................... 3666Saccharum ............................................................................... 3664Saccharum liquidum........................................................ 9.4-5448Salbutamoli sulfas .................................................................. 3526Salbutamolum ......................................................................... 3523Salicis cortex ............................................................................ 1561Salicis corticis extractum siccum ........................................... 1562Salmeteroli xinafoas................................................................ 3529Salmonis domestici oleum ...................................................... 3531Salviae lavandulifoliae aetheroleum ..................................... 1524Salviae miltiorrhizae radix et rhizoma .......................... 9.1-4108Salviae officinalis folium ........................................................ 1505Salviae sclareae aetheroleum ................................................. 1320Salviae tinctura ....................................................................... 1507Salviae trilobae folium............................................................ 1506Sambuci flos ............................................................................. 1342Sanguisorbae radix.................................................................. 1509Saquinaviri mesilas ................................................................. 3533



Schisandrae chinensis fructus .......................................... 9.1-4110Scopolamini butylbromidum .......................................... 9.6-6121Scopolamini hydrobromidum ................................................ 2735Scopolaminum ......................................................................... 2733Scutellariae baicalensis radix ................................................. 1262Selamectinum ad usum veterinarium ................................... 3535Selegilini hydrochloridum ...................................................... 3537Selenii disulfidum.................................................................... 3538Selenium ad praeparationes homoeopathicas ............... 9.2-4494Semecarpus anacardium ad praeparationeshomoeopathicas ..................................................................... 1591

Sennae folii extractum siccum normatum ............................ 1517Sennae folium .......................................................................... 1516Sennae fructus acutifoliae ...................................................... 1518Sennae fructus angustifoliae................................................... 1519Serinum .................................................................................... 3539Serpylli herba ........................................................................... 1559Sertaconazoli nitras ................................................................ 3540Sertralini hydrochloridum............................................... 9.7-6677Serum bovinum ....................................................................... 1863Sesami oleum raffinatum ................................................ 9.1-4197Sevofluranum.................................................................... 9.5-5749Sildenafili citras ................................................................ 9.2-4611Silica ad usum dentalem ........................................................ 3550Silica colloidalis anhydrica..................................................... 3549Silica colloidalis hydrica ......................................................... 3550Silica hydrophobica colloidalis............................................... 3551Silybi mariani extractum siccum raffinatum etnormatum ....................................................................... 9.6-5998

Silybi mariani fructus ............................................................. 1441Simeticonum ............................................................................ 3553Simvastatinum.................................................................. 9.7-6679Sinomenii caulis ...................................................................... 1466Sitagliptini compressi .............................................................. 3557Sitagliptini phosphas monohydricus............................... 9.1-4198Soiae oleum hydrogenatum .................................................... 3630Soiae oleum raffinatum ................................................... 9.3-4992Solani amylum ........................................................................ 3390Solidaginis herba ..................................................................... 1375Solidaginis virgaureae herba .................................................. 1376Solifenacini succinas ........................................................ 9.3-4991Solutiones ad conservationem partium corporis .................. 3612Solutiones ad haemocolaturam haemodiacolaturamque ..... 9.6-6119

Solutiones ad haemodialysem ......................................... 9.6-6115Solutiones ad peritonealem dialysem ............................. 9.6-6175Solutiones anticoagulantes et sanguinem humanumconservantes........................................................................... 1738

Solutiones concentratae ad haemocolaturamhaemodiacolaturamque ................................................. 9.6-6117

Somatostatinum ...................................................................... 3613Somatropini solutio concentrata ..................................... 9.5-5752Somatropini solutio iniectabilis ............................................. 3620Somatropinum .................................................................. 9.5-5750Somatropinum iniectabile ............................................... 9.5-5754Sophorae flavescentis radix ............................................. 9.6-5996Sophorae japonicae flos .......................................................... 1520Sophorae japonicae flos immaturus ...................................... 1522Sorbitani lauras ................................................................ 9.1-4203Sorbitani oleas .................................................................. 9.1-4203Sorbitani palmitas ............................................................ 9.1-4204Sorbitani sesquioleas ........................................................ 9.1-4205Sorbitani stearas ............................................................... 9.1-4205Sorbitani trioleas .............................................................. 9.1-4206Sorbitolum ............................................................................... 3625Sorbitolum liquidum cristallisabile ....................................... 3626Sorbitolum liquidum non cristallisabile................................ 3627Sorbitolum liquidum partim deshydricum ........................... 3628Sotaloli hydrochloridum ......................................................... 3629Spectinomycini dihydrochloridum pentahydricum ............. 3631Spectinomycini sulfas tetrahydricus ad usumveterinarium .......................................................................... 3633

Spicae aetheroleum .......................................................... 9.5-5617

Spiramycinum .................................................................. 9.2-4612Spiraprili hydrochloridum monohydricum .......................... 3638Spironolactonum ..................................................................... 3639Squalanum............................................................................... 3641Stanni colloidalis et technetii (99mTc) solutio iniectabilis..... 1185Stanni pyrophosphatis et technetii (99mTc) solutioiniectabilis .............................................................................. 1199

Stannosi chloridum dihydricum ............................................ 3644Stanozololum ........................................................................... 3644Stavudinum.............................................................................. 3653Stephaniae tetrandrae radix................................................... 1357Stramonii folium .............................................................. 9.2-4473Stramonii pulvis normatus.............................................. 9.2-4475Streptokinasi solutio concentrata.................................... 9.6-6212Streptomycini sulfas ......................................................... 9.6-6213Strontii (89Sr) chloridi solutio iniectabilis ............................. 1181Strychnos ignatii ad praeparationes homoeopathicas... 9.3-4827Strychnos nux-vomica ad praeparationes homoeopathicas.. 9.3-4829

Styli .................................................................................... 9.6-5914Sucralfatum....................................................................... 9.4-5447Sucralosum........................................................................ 9.2-4615Sufentanili citras ..................................................................... 3669Sufentanilum ........................................................................... 3668Sulbactamum natricum .......................................................... 3671Sulfacetamidum natricum...................................................... 3673Sulfadiazinum ......................................................................... 3674Sulfadimethoxinum.......................................................... 9.4-5450Sulfadimethoxinum natricum ad usum veterinarium .. 9.4-5451Sulfadimidinum....................................................................... 3678Sulfadoxinum .......................................................................... 3680Sulfafurazolum ........................................................................ 3681Sulfaguanidinum ..................................................................... 3681Sulfamerazinum ...................................................................... 3682Sulfamethizolum ..................................................................... 3683Sulfamethoxazolum ................................................................ 3684Sulfamethoxypyridazinum ad usum veterinarium.............. 3685Sulfanilamidum....................................................................... 3686Sulfasalazinum ................................................................. 9.2-4617Sulfathiazolum......................................................................... 3689Sulfinpyrazonum ..................................................................... 3689Sulfobutylbetadexum natricum ...................................... 9.6-6215Sulfur ad praeparationes homoeopathicas............................ 1614Sulfur ad usum externum....................................................... 3691Sulfuris colloidalis et technetii (99mTc) solutio iniectabilis... 1184Sulindacum .............................................................................. 3692Sulpiridum ............................................................................... 3693Sultamicillini tosilas dihydricus............................................. 3697Sultamicillinum ....................................................................... 3694Sumatriptani succinas ............................................................ 3699Suxamethonii chloridum ........................................................ 3701Suxibuzonum........................................................................... 3702

TTacalcitolum monohydricum ................................................. 3707Tacrolimusum monohydricum ....................................... 9.3-4997Tadalafilum.............................................................................. 3708Talcum...................................................................................... 3710Tamoxifeni citras ..................................................................... 3712Tamponae medicatae ................................................................ 887Tamsulosini hydrochloridum ................................................. 3714Tanaceti parthenii herba ........................................................ 1355Tanninum ................................................................................ 3716Taraxaci officinalis herba cum radice ................................... 1332Taraxaci officinalis radix........................................................ 1333Technetii (99mTc) bicisati solutio iniectabilis.................. 9.2-4440Technetii (99mTc) et etifenini solutio iniectabilis................... 1185Technetii (99mTc) exametazimi solutio iniectabilis ............... 1187Technetii (99mTc) gluconatis solutio iniectabilis.................... 1188Technetii (99mTc) humani albumini solutio iniectabilis....... 1189Technetii (99mTc) macrosalbi suspensio iniectabilis.............. 1190Technetii (99mTc) mebrofenini solutio iniectabilis ......... 9.2-4440



Technetii (99mTc) medronati solutio iniectabilis ................... 1192Technetii (99mTc) mertiatidi solutio iniectabilis.................... 1193Technetii (99mTc) microsphaerarum suspensio iniectabilis .. 1194Technetii (99mTc) oxidronati solutio iniectabilis ................... 1195Technetii (99mTc) pentetatis solutio iniectabilis .................... 1196Technetii (99mTc) sestamibi solutio iniectabilis .............. 9.2-4441Technetii (99mTc) succimeri solutio iniectabilis..................... 1199Teicoplaninum......................................................................... 3717Telmisartanum ................................................................. 9.7-6685Temazepamum ........................................................................ 3720Temozolomidum .............................................................. 9.7-6686Tenoxicamum ................................................................... 9.4-5456Terazosini hydrochloridum dihydricum ............................... 3724Terbinafini hydrochloridum .................................................. 3727Terbutalini sulfas .................................................................... 3728Terconazolum .......................................................................... 3729Terebinthinae aetheroleum ............................................. 9.4-5316Terfenadinum .......................................................................... 3730Teriparatidum ......................................................................... 3732Terlipressinum .................................................................. 9.2-4623Terpinum monohydricum ............................................... 9.7-6688tert-Butylamini perindoprilum.............................................. 3296Testosteroni decanoas ............................................................. 3736Testosteroni enantas ............................................................... 3738Testosteroni isocaproas ........................................................... 3740Testosteroni propionas ............................................................ 3741Testosteronum ......................................................................... 3734Tetracaini hydrochloridum .................................................... 3742Tetracosactidum ...................................................................... 3743Tetracyclini hydrochloridum.................................................. 3746Tetracyclinum.......................................................................... 3744Tetra-O-acetylmannosi triflas ad radiopharmaceutica........ 9.2-4443

Tetrazepamum ........................................................................ 3747Tetryzolini hydrochloridum ................................................... 3749Thallosi (201Tl) chloridi solutio iniectabilis ........................... 1202Theobrominum........................................................................ 3749Theophyllinum ........................................................................ 3750Theophyllinum et ethylenediaminum ................................... 3752Theophyllinum et ethylenediaminum hydricum.................. 3754Theophyllinum monohydricum ............................................. 3751Thiamazolum .......................................................................... 3755Thiamini hydrochloridum...................................................... 3756Thiamini nitras ....................................................................... 3758Thiamphenicolum ................................................................... 3760Thiocolchicosidum ex ethanolo cristallisatum............... 9.3-4999Thiocolchicosidum hydricum .......................................... 9.3-5002Thiomersalum ......................................................................... 3766Thiopentalum natricum et natrii carbonas .......................... 3767Thioridazini hydrochloridum ................................................ 3770Thioridazinum ........................................................................ 3768Threoninum ............................................................................. 3771Thymi herba ............................................................................ 1538Thymi typo thymolo aetheroleum ......................................... 1540Thymolum................................................................................ 3772Tiabendazolum ........................................................................ 3773Tiamulini hydrogenofumaras ad usum veterinarium ......... 3777Tiamulinum ad usum veterinarium...................................... 3774Tianeptinum natricum ........................................................... 3779Tiapridi hydrochloridum ........................................................ 3781Tibolonum ................................................................................ 3783Ticarcillinum natricum........................................................... 3784Ticlopidini hydrochloridum ................................................... 3786Tigecyclinum ..................................................................... 9.6-6221Tiliae flos .................................................................................. 1414Tilidini hydrochloridum hemihydricum ............................... 3788Timololi maleas ....................................................................... 3789Tincturae maternae ad praeparationes homoeopathicas .... 1571Tinidazolum............................................................................. 3791Tinzaparinum natricum ......................................................... 3792Tioconazolum .......................................................................... 3793Tiotropii bromidum monohydricum .............................. 9.3-5004Titanii dioxidum ..................................................................... 3796

Tizanidini hydrochloridum .................................................... 3797Tobramycinum ........................................................................ 3799α-Tocopherylis acetatis pulvis ................................................ 3805Tolbutamidum ........................................................................ 3810Tolnaftatum ............................................................................. 3812Tolterodini tartras................................................................... 3813Torasemidum........................................................................... 3815Tormentillae rhizoma ............................................................. 1542Tormentillae tinctura.............................................................. 1542Tosylchloramidum natricum ................................................. 3816Toxinum botulinicum A ad iniectabile .......................... 9.6-6039Toxinum botulinicum B ad iniectabile .......................... 9.6-6041Tragacantha............................................................................. 1543Tramadoli hydrochloridum.................................................... 3817Tramazolini hydrochloridum monohydricum ..................... 3818Trandolaprilum ....................................................................... 3819Trapidilum ............................................................................... 3822Trehalosum dihydricum ......................................................... 3823Tretinoinum............................................................................. 3824Triacetinum ............................................................................. 3825Triamcinoloni acetonidum .................................................... 3827Triamcinoloni hexacetonidum .............................................. 3829Triamcinolonum ..................................................................... 3826Triamterenum ......................................................................... 3830Tribenosidum .......................................................................... 3832Tributylis acetylcitras.............................................................. 3833Tricalcii phosphas ................................................................... 1929Triclabendazolum ad usum veterinarium ............................ 3836Triethylis citras ........................................................................ 3837Trifluoperazini hydrochloridum ............................................ 3837Triflusalum .............................................................................. 3838Triglycerida media .................................................................. 3839Triglyceroli diisostearas .......................................................... 3841Trigonellae foenugraeci semen ........................................ 9.6-5991Trihexyphenidyli hydrochloridum......................................... 3841Trimebutini maleas.......................................................... 9.3-5005Trimetazidini dihydrochloridum ........................................... 3843Trimethadionum ..................................................................... 3845Trimethoprimum .................................................................... 3846Trimipramini maleas.............................................................. 3848Tri-n-butylis phosphas............................................................ 3834Tritici aestivi oleum raffinatum............................................. 3937Tritici aestivi oleum virginale ................................................ 3938Tritici amylum ........................................................................ 3937Trolaminum............................................................................. 3849Trometamolum........................................................................ 3851Tropicamidum ......................................................................... 3852Tropisetroni hydrochloridum................................................. 3853Trospii chloridum.................................................................... 3855Troxerutinum ................................................................... 9.3-5007Trypsinum................................................................................ 3857Tryptophanum......................................................................... 3858Tuberculini aviarii derivatum proteinosum purificatum ... 3862Tuberculini bovini derivatum proteinosum purificatum .... 3863Tuberculini derivatum proteinosum purificatum ad usumhumanum .............................................................................. 3864

Tuberculinum pristinum ad usum humanum ..................... 3861Tylosini phosphas ad usum veterinarium...................... 9.3-5017Tylosini phosphatis solutio ad usum veterinarium....... 9.3-5012Tylosini tartras ad usum veterinarium.......................... 9.3-5021Tylosinum ad usum veterinarium .................................. 9.3-5008Typhae pollis ..................................................................... 9.7-6556Tyrosinum ................................................................................ 3870Tyrothricinum ......................................................................... 3871

UUbidecarenonum ..................................................................... 3875Uncariae rhynchophyllae ramulus cum uncis ............... 9.3-4821Ureum ...................................................................................... 3877Urofollitropinum .............................................................. 9.4-5463Urokinasum ...................................................................... 9.4-5464Urtica dioica ad praeparationes homoeopathicas ................ 1614



Urticae folium.......................................................................... 1450Urticae radix............................................................................ 1452Uvae ursi folium ...................................................................... 1264

VVaccina ad usum humanum ........................................... 9.5-5571Vaccina ad usum veterinarium....................................... 9.5-5574Vaccinum actinobacillosidis inactivatum ad suem .............. 1085Vaccinum adenovirosidis caninae vivum ............................. 1028Vaccinum adenovirosis caninae inactivatum....................... 1027Vaccinum anaemiae infectivae pulli vivum .................. 9.5-5598Vaccinum anthracis adsorbatum ab colato culturarum ad usumhumanum ....................................................................... 9.6-5919

Vaccinum anthracis vivum ad usum veterinarium ............. 1003Vaccinum aphtharum epizooticarum inactivatum adruminantes...................................................................... 9.5-5597

Vaccinum Bordetellae bronchisepticae vivum ad canem .... 1018Vaccinum bronchitidis infectivae aviariae inactivatum...... 1007Vaccinum bronchitidis infectivae aviariae vivum................ 1008Vaccinum brucellosis (Brucella melitensis stirps Rev. 1) vivumad usum veterinarium .......................................................... 1024

Vaccinum bursitidis infectivae aviariae inactivatum .......... 1010Vaccinum bursitidis infectivae aviariae vivum .................... 1011Vaccinum calicivirosis felinae inactivatum .......................... 1053Vaccinum calicivirosis felinae vivum .................................... 1054Vaccinum chlamydiosidis felinae inactivatum ..................... 1055Vaccinum cholerae aviariae inactivatum ............................. 1063Vaccinum cholerae perorale inactivatum ............................... 898Vaccinum Clostridii botulini ad usum veterinarium .......... 1035Vaccinum Clostridii chauvoei ad usum veterinarium......... 1036Vaccinum Clostridii novyi B ad usum veterinarium ........... 1036Vaccinum Clostridii perfringentis ad usum veterinarium .. 1038Vaccinum Clostridii septici ad usum veterinarium ............. 1040Vaccinum coccidiosidis vivum ad pullum............................. 1042Vaccinum colibacillosis fetus a partu recentis inactivatum adruminantes............................................................................. 1079

Vaccinum colibacillosis fetus a partu recentis inactivatum adsuem ....................................................................................... 1077

Vaccinum diarrhoeae viralis bovinae inactivatum .............. 1023Vaccinum diphtheriae adsorbatum ......................................... 924Vaccinum diphtheriae, antigeniis minutum, adsorbatum .... 925Vaccinum diphtheriae et tetani adsorbatum .......................... 899Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum .............................................................................. 900

Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum .............................................................................. 901

Vaccinum diphtheriae, tetani et pertussis ex cellulis integrisadsorbatum .............................................................................. 905

Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum ..................................... 902

Vaccinum diphtheriae, tetani et pertussis sine cellulisex elementis praeparatum, antigeni-o(-is) minutum,adsorbatum .............................................................................. 903

Vaccinum diphtheriae, tetani et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum .................................. 906

Vaccinum diphtheriae, tetani, pertussis ex cellulis integris etpoliomyelitidis inactivatum adsorbatum .............................. 920

Vaccinum diphtheriae, tetani, pertussis ex cellulis integris,poliomyelitidis inactivatum et haemophili stirpis b coniugatumadsorbatum ..................................................................... 9.5-5590

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et haemophili stirpis b coniugatumadsorbatum ..................................................................... 9.6-5920

Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementispraeparatum et hepatitidis B (ADNr) adsorbatum ............. 910

Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementispraeparatum et poliomyelitidis inactivatum adsorbatum .. 911

Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementispraeparatum et poliomyelitidis inactivatum, antigeni-o(-is)minutum, adsorbatum............................................................ 913

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, hepatitidis B (ADNr), poliomyelitidisinactivatum et haemophili stirpis b coniugatumadsorbatum ..................................................................... 9.5-5585

Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementispraeparatum, poliomyelitidis inactivatum et haemophilistirpis b coniugatum adsorbatum ................................. 9.5-5587

Vaccinum encephalitidis ixodibus advectae inactivatum..... 9.6-5968

Vaccinum encephalomyelitidis infectivae aviariae vivum .. 1013Vaccinum erysipelatis suillae inactivatum............................ 1104Vaccinum febris flavae vivum ......................................... 9.6-5973Vaccinum febris typhoidis ............................................... 9.6-5972Vaccinum febris typhoidis polysaccharidicum............... 9.6-5970Vaccinum febris typhoidis vivum perorale (stirpis Ty 21a) .. 992Vaccinum furunculosidis inactivatum ad salmonidas cumadiuvatione oleosa ad iniectionem ............................... 9.2-4427

Vaccinum haemophili stirpi b et meningococcale classis Cconiugatum .............................................................................. 926

Vaccinum haemophili stirpis b coniugatum .................. 9.6-5922Vaccinum hepatitidis A inactivatum adsorbatum ........ 9.6-5926Vaccinum hepatitidis A inactivatum adsorbatum et febristyphoidis polysaccharidicum ......................................... 9.6-5924

Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum ..................................................................... 9.6-5925

Vaccinum hepatitidis A inactivatum virosomale .......... 9.6-5927Vaccinum hepatitidis B (ADNr) ..................................... 9.6-5930Vaccinum hepatitidis viralis anatis stirpis I vivum ............. 1047Vaccinum herpesviris equini inactivatum ............................ 1050Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ...................................................................................... 1025

Vaccinum inactivatum diarrhoeae vituli rotaviro illatae ... 1026Vaccinum influenzae equinae inactivatum .......................... 1051Vaccinum influenzae inactivatum ad suem ......................... 1087Vaccinum influenzae inactivatum ex cellulis corticisqueantigeniis praeparatum ................................................. 9.6-5938

Vaccinum influenzae inactivatum ex cellulis virisque integrispraeparatum ................................................................... 9.6-5943

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum ................................................................... 9.6-5936

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum virosomale ............................................... 9.6-5940

Vaccinum influenzae inactivatum ex viris integrispraeparatum ................................................................... 9.6-5942

Vaccinum influenzae inactivatum ex virorum fragmentispraeparatum ................................................................... 9.6-5934

Vaccinum influenzae vivum pernasale ................................... 939Vaccinum laryngotracheitidis infectivae aviariae vivum .... 1014Vaccinum leptospirosis bovinae inactivatum ....................... 1019Vaccinum leptospirosis caninae inactivatum ....................... 1030Vaccinum leucosis felinae inactivatum ................................. 1058Vaccinum mannheimiae bovinae inactivatum .................... 1071Vaccinum mannheimiae inactivatum ad ovem ................... 1072Vaccinum meningococcale classis C coniugatum .......... 9.6-5949Vaccinum meningococcale polysaccharidicum .............. 9.6-5950Vaccinum morbi Aujeszkyi ad suem inactivatum ............... 1003Vaccinum morbi Aujeszkyi vivum ad suem ad usumparenteralem.......................................................................... 1005

Vaccinum morbi Carrei vivum ad canem............................. 1029Vaccinum morbi Carrei vivum ad mustelidas ..................... 1045Vaccinum morbi haemorrhagici cuniculi inactivatum........ 1092Vaccinum morbillorum, parotitidis et rubellae vivum .. 9.6-5945Vaccinum morbillorum, parotitidis, rubellae et varicellaevivum............................................................................... 9.6-5946

Vaccinum morbillorum vivum........................................ 9.6-5947Vaccinum morbi Marek vivum .............................................. 1073Vaccinum morbi partus diminutionis MCMLXXVI inactivatumad pullum............................................................................... 1048

Vaccinum Mycoplasmatis galliseptici inactivatum .............. 1075Vaccinum myxomatosidis vivum ad cuniculum .................. 1076Vaccinum panleucopeniae felinae infectivae inactivatum .. 1056Vaccinum panleucopeniae felinae infectivae vivum ............ 1057Vaccinum papillomaviri humani (ADNr) ..................... 9.6-5931



Vaccinum parainfluenzae viri canini vivum ........................ 1032Vaccinum paramyxoviris 3 aviarii inactivatum admeleagrem .............................................................................. 1016

Vaccinum parotitidis vivum ............................................ 9.6-5952Vaccinum parvovirosis caninae inactivatum ....................... 1033Vaccinum parvovirosis caninae vivum ................................. 1034Vaccinum parvovirosis inactivatum ad suem ...................... 1089Vaccinum pasteurellae inactivatum ad ovem....................... 1084Vaccinum pertussis ex cellulis integris adsorbatum ............... 963Vaccinum pertussis sine cellulis copurificatum adsorbatum .. 962Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum .............................................................................. 960

Vaccinum pestis anatis vivum ................................................ 1046Vaccinum pestis classicae suillae vivum ex cellulis .............. 1104Vaccinum pneumococcale polysaccharidicum............... 9.6-5955Vaccinum pneumococcale polysaccharidicum coniugatumadsorbatum ..................................................................... 9.6-5953

Vaccinum pneumoniae enzooticae suillae inactivatum ...... 1086Vaccinum poliomyelitidis inactivatum .......................... 9.6-5957Vaccinum poliomyelitidis perorale ................................. 9.1-4091Vaccinum pseudopestis aviariae inactivatum ...................... 1080Vaccinum pseudopestis aviariae vivum ................................ 1082Vaccinum rabiei ex cellulis ad usum humanum ........... 9.6-5959Vaccinum rabiei inactivatum ad usum veterinarium ......... 1093Vaccinum rabiei perorale vivum ad vulpem etnyctereutem ........................................................................... 1096

Vaccinum rhinitidis atrophicantis ingravescentis suillaeinactivatum............................................................................ 1090

Vaccinum rhinotracheitidis infectivae bovinaeinactivatum............................................................................ 1067

Vaccinum rhinotracheitidis infectivae bovinae vivum ........ 1068Vaccinum rhinotracheitidis infectivae vivum admeleagrem .............................................................................. 1107

Vaccinum rhinotracheitidis viralis felinae inactivatum ...... 1059Vaccinum rhinotracheitidis viralis felinae vivum ................ 1060Vaccinum rotaviri vivum perorale .......................................... 978Vaccinum rubellae vivum................................................ 9.6-5962Vaccinum Salmonellae Enteritidis inactivatum adpullum .................................................................................... 1097

Vaccinum Salmonellae Enteritidis vivum perorale adpullum .................................................................................... 1098

Vaccinum Salmonellae Typhimurium inactivatum adpullum .................................................................................... 1100

Vaccinum Salmonellae Typhimurium vivum perorale adpullum .................................................................................... 1101

Vaccinum tenosynovitidis viralis aviariae vivum ................ 1017Vaccinum tetani adsorbatum ................................................... 987Vaccinum tetani ad usum veterinarium ............................... 1106Vaccinum tuberculosis (BCG) cryodesiccatum ....................... 895Vaccinum varicellae vivum ............................................. 9.6-5972Vaccinum variolae gallinaceae vivum ................................. 1064Vaccinum variolae vivum................................................ 9.6-5964Vaccinum vibriosidis aquae frigidae inactivatum adsalmonidas ...................................................................... 9.2-4428

Vaccinum vibriosidis inactivatum ad salmonidas ....... 9.2-4429Vaccinum viri parainfluenzae bovini vivum ........................ 1021Vaccinum viri syncytialis meatus spiritus bovini vivum ..... 1022Vaccinum yersiniosidis inactivatum ad salmonidas ..... 9.2-4430Vaccinum zonae vivum ................................................... 9.6-5963Vaginalia .................................................................................... 887Valacicloviri hydrochloridum ......................................... 9.3-5029Valacicloviri hydrochloridum hydricum ........................ 9.3-5032Valerianae extractum aquosum siccum ................................ 1549Valerianae extractum hydroalcoholicum siccum ................. 1550Valerianae radix ............................................................... 9.1-4111Valerianae radix minutata .............................................. 9.1-4113Valerianae tinctura ................................................................. 1554Valinum.................................................................................... 3890Valnemulini hydrochloridum ad usum veterinarium ......... 3892

Valsartanum ............................................................................ 3895Vancomycini hydrochloridum................................................ 3896Vanillinum ............................................................................... 3898Vardenafili hydrochloridum trihydricum ............................. 3898Vaselinum album .................................................................... 3270Vaselinum flavum ................................................................... 3271Vecuronii bromidum ....................................................... 9.1-4211Vedaprofenum ad usum veterinarium.................................. 3901Venlafaxini hydrochloridum .................................................. 3902Verapamili hydrochloridum................................................... 3904Verbasci flos ............................................................................. 1445Verbenae citriodorae folium .................................................. 1412Verbenae herba........................................................................ 1555Via praeparandi stirpes homoeopathicas et potentificandi .. 9.2-4479

Vigabatrinum........................................................................... 3906Vinblastini sulfas ..................................................................... 3907Vincristini sulfas ...................................................................... 3908Vindesini sulfas ................................................................. 9.3-5034Vinorelbini tartras............................................................ 9.4-5469Vinpocetinum .......................................................................... 3914Violae herba cum flore ............................................................ 1558Vitamini A synthetici densati pulvis .............................. 9.3-5037Vitaminum A ........................................................................... 3917Vitaminum A syntheticum densatum oleosum ............. 9.3-5036Vitaminum A syntheticum, solubilisatum densatum in aquadispergibile ...................................................................... 9.3-5038

Voriconazolum ........................................................................ 3921

WWarfarinum natricum............................................................ 3927Warfarinum natricum clathratum........................................ 3928

XXanthani gummi .............................................................. 9.2-4627Xenoni (133Xe) solutio iniectabilis .......................................... 1204Xylazini hydrochloridum ad usum veterinarium ................ 3948Xylitolum ................................................................................. 3949Xylometazolini hydrochloridum ............................................ 3951Xylosum.................................................................................... 3953

YYohimbini hydrochloridum.................................................... 3957Yttrii (90Y) chloridi solutio ad radio-signandum........... 9.7-6537

ZZanamivirum hydricum ......................................................... 3961Zanthoxyli bungeani pericarpium......................................... 1565Zidovudinum ........................................................................... 3962Zinci acetas dihydricus ........................................................... 3964Zinci acexamas ........................................................................ 3965Zinci chloridum ....................................................................... 3967Zinci gluconas .......................................................................... 3967Zinci oxidum ........................................................................... 3968Zinci stearas ............................................................................. 3968Zinci sulfas heptahydricus ...................................................... 3969Zinci sulfas hexahydricus ....................................................... 3970Zinci sulfas monohydricus...................................................... 3970Zinci undecylenas .................................................................... 3970Zingiberis rhizoma .................................................................. 1367Ziprasidoni hydrochloridum monohydricum....................... 3971Ziprasidoni mesilas trihydricus ............................................. 3973Zolmitriptanum................................................................ 9.5-5759Zolpidemi tartras .................................................................... 3975Zopiclonum .............................................................................. 3976Zuclopenthixoli decanoas ....................................................... 3978


europeanpharmacopoeia9.7 index · europeanpharmacopoeia9.7 index to aid users the index includes a...

Documents