EUROPEAN PHARMACOPOEIA 8.0

INDEXEnglish index ...................................................................... 3605 Latin index ............................................................................... 3639

General Notices (1) apply to all monographs and other texts 3603

EUROPEAN PHARMACOPOEIA 8.0

3604 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0 Index

Numerics1. General notices ......................................................................... 32.1.1. 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............................................................ 172.1. 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................................. 322.2.15. Melting point - open capillary method ....................... 322.2.16. Melting point - instantaneous method........................ 322.2.17. Drop point ...................................................................... 322.2.18. Freezing point................................................................. 342.2.19. Amperometric titration................................................. 342.2.1. Clarity and degree of opalescence of liquids ................ 212.2.20. Potentiometric titration ................................................ 342.2.21. Fluorimetry..................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................. 362.2.24. Absorption spectrophotometry, infrared.................... 382.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 40

2.2.26. Paper chromatography .................................................. 422.2.27. Thin-layer chromatography.......................................... 422.2.28. Gas chromatography...................................................... 432.2.29. Liquid chromatography................................................. 452.2.2. Degree of coloration of liquids....................................... 222.2.30. Size-exclusion chromatography ................................... 462.2.31. Electrophoresis ............................................................... 472.2.31. Electrophoresis (5.8.)................................................... 6772.2.32. Loss on drying................................................................ 522.2.33. Nuclear magnetic resonance spectrometry ................ 522.2.34. Thermal analysis ............................................................ 552.2.35. Osmolality....................................................................... 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 58

2.2.37. X-ray fluorescence spectrometry ................................. 592.2.38. Conductivity ................................................................... 592.2.39. Molecular mass distribution in dextrans .................... 602.2.3. Potentiometric determination of pH............................. 242.2.40. Near-infrared spectroscopy .......................................... 622.2.41. Circular dichroism......................................................... 672.2.42. Density of solids............................................................. 682.2.43. Mass spectrometry......................................................... 692.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 71

2.2.45. Supercritical fluid chromatography ............................. 722.2.46. Chromatographic separation techniques .................... 722.2.47. Capillary electrophoresis............................................... 792.2.47. Capillary electrophoresis (5.8.) .................................. 6772.2.48. Raman spectrometry ..................................................... 842.2.49. Falling ball viscometer method.................................... 852.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators ................ 25

2.2.54. Isoelectric focusing ........................................................ 852.2.54. Isoelectric focusing (5.8.) ............................................ 6772.2.55. Peptide mapping ............................................................ 872.2.55. Peptide mapping (5.8.) ................................................ 6772.2.56. Amino acid analysis....................................................... 902.2.56. Amino acid analysis (5.8.)........................................... 6772.2.57. Inductively coupled plasma-atomic emissionspectrometry ............................................................................. 97

2.2.58. Inductively coupled plasma-mass spectrometry........ 982.2.59. Glycan analysis of glycoproteins ................................ 1002.2.5. Relative density................................................................. 252.2.60. Melting point - instrumental method ....................... 105

2.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 106

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 109

2.2.65. Voltametric titration .................................................... 1092.2.66. Detection and measurement of radioactivity ........... 1102.2.6. Refractive index................................................................ 262.2.7. Optical rotation ................................................................ 262.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.2. Physical and physicochemical methods ........................... 212.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 119

2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 122

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 123

2.3.4. Odour .............................................................................. 1232.3. Identification...................................................................... 1192.4.10. Lead in sugars............................................................... 1312.4.11. Phosphates .................................................................... 1312.4.12. Potassium...................................................................... 1322.4.13. Sulfates........................................................................... 1322.4.14. Sulfated ash ................................................................... 1322.4.14. Sulfated ash (5.8.)......................................................... 6782.4.15. Nickel in polyols........................................................... 1322.4.16. Total ash ........................................................................ 1322.4.17. Aluminium ................................................................... 1322.4.18. Free formaldehyde ....................................................... 1322.4.19. Alkaline impurities in fatty oils.................................. 1332.4.1. Ammonium .................................................................... 1272.4.20. Determination of metal catalyst or metal reagentresidues .................................................................................... 133

2.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 136

2.4.22. Composition of fatty acids by gas chromatography.. 1362.4.23. Sterols in fatty oils........................................................ 1392.4.24. Identification and control of residual solvents ......... 1412.4.25. Ethylene oxide and dioxan.......................................... 1452.4.26. N,N-Dimethylaniline ................................................... 1462.4.27. Heavy metals in herbal drugs and fatty oils ............. 1472.4.28. 2-Ethylhexanoic acid ................................................... 1482.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 148

2.4.2. Arsenic............................................................................. 1272.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 150

2.4.31. Nickel in hydrogenated vegetable oils ....................... 1502.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1512.4.3. Calcium ........................................................................... 1272.4.4. Chlorides ......................................................................... 1272.4.5. Fluorides.......................................................................... 1282.4.6. Magnesium ..................................................................... 1282.4.7. Magnesium and alkaline-earth metals ........................ 1282.4.8. Heavy metals................................................................... 1282.4.9. Iron .................................................................................. 1312.4. Limit tests........................................................................... 1272.5.10. Oxygen-flask method .................................................. 1582.5.11. Complexometric titrations.......................................... 1582.5.12. Water : semi-micro determination ............................. 1582.5.13. Aluminium in adsorbed vaccines .............................. 1592.5.14. Calcium in adsorbed vaccines .................................... 1592.5.15. Phenol in immunosera and vaccines......................... 1592.5.16. Protein in polysaccharide vaccines ............................ 1592.5.17. Nucleic acids in polysaccharide vaccines .................. 1602.5.18. Phosphorus in polysaccharide vaccines .................... 1602.5.19. O-Acetyl in polysaccharide vaccines ......................... 1602.5.1. Acid value........................................................................ 1552.5.20. Hexosamines in polysaccharide vaccines.................. 1602.5.21. Methylpentoses in polysaccharide vaccines.............. 1612.5.22. Uronic acids in polysaccharide vaccines ................... 1612.5.23. Sialic acid in polysaccharide vaccines ....................... 1612.5.24. Carbon dioxide in gases .............................................. 161

General Notices (1) apply to all monographs and other texts 3605

Index EUROPEAN PHARMACOPOEIA 8.0

2.5.25. Carbon monoxide in gases ......................................... 1622.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1632.5.27. Oxygen in gases............................................................ 1632.5.28. Water in gases............................................................... 1632.5.29. Sulfur dioxide ............................................................... 1642.5.2. Ester value....................................................................... 1552.5.30. Oxidising substances ................................................... 1642.5.31. Ribose in polysaccharide vaccines ............................. 1642.5.32. Water : micro determination....................................... 1642.5.33. Total protein ................................................................. 1652.5.34. Acetic acid in synthetic peptides................................ 1682.5.35. Nitrous oxide in gases ................................................. 1682.5.36. Anisidine value............................................................. 1692.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 169

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 170

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 171

2.5.3. Hydroxyl value ............................................................... 1552.5.4. Iodine value .................................................................... 1552.5.5. Peroxide value................................................................. 1562.5.6. Saponification value....................................................... 1572.5.7. Unsaponifiable matter ................................................... 1572.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 157

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 157

2.5. Assays ................................................................................. 1552.6.10. Histamine...................................................................... 1842.6.11. Depressor substances................................................... 1852.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 185

2.6.12. Microbiological examination of non-sterile products :microbial enumeration tests (5.8.) ....................................... 678

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 189

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms (5.8.) ............................. 678

2.6.14. Bacterial endotoxins .................................................... 1942.6.15. Prekallikrein activator ................................................. 1982.6.16. Tests for extraneous agents in viral vaccines for humanuse ............................................................................................ 198

2.6.17. Test for anticomplementary activity ofimmunoglobulin..................................................................... 200

2.6.18. Test for neurovirulence of live virus vaccines .......... 2022.6.19. Test for neurovirulence of poliomyelitis vaccine(oral)......................................................................................... 202

2.6.1. Sterility ............................................................................ 1752.6.1. Sterility (5.8.) .................................................................. 6782.6.20. Anti-A and anti-B haemagglutinins .......................... 2032.6.21. Nucleic acid amplification techniques....................... 2042.6.22. Activated coagulation factors ..................................... 2092.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 209

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 212

2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 215

2.6.27. Microbiological control of cellular products ............ 2162.6.2. Mycobacteria .................................................................. 1782.6.30. Monocyte-activation test............................................. 2172.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 222

2.6.33. Residual pertussis toxin and irreversibility of pertussistoxoid ....................................................................................... 224

2.6.7. Mycoplasmas .................................................................. 1782.6.8. Pyrogens.......................................................................... 1832.6.9. Abnormal toxicity .......................................................... 1842.6. Biological tests ................................................................... 1752.7.10. Assay of human coagulation factor VII .................... 2472.7.11. Assay of human coagulation factor IX ...................... 248

2.7.12. Assay of heparin in coagulation factors .................... 2492.7.13. Assay of human anti-D immunoglobulin ................. 2492.7.14. Assay of hepatitis A vaccine ....................................... 2512.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2522.7.16. Assay of pertussis vaccine (acellular) ........................ 2522.7.17. Assay of human antithrombin III .............................. 2542.7.18. Assay of human coagulation factor II ....................... 2542.7.19. Assay of human coagulation factor X........................ 2552.7.19. Assay of human coagulation factor X (2.7.19.) ........ 2552.7.1. Immunochemical methods........................................... 2292.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2552.7.21. Assay of human von Willebrand factor..................... 2572.7.22. Assay of human coagulation factor XI ...................... 2582.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products ....................................................... 258

2.7.24. Flow cytometry ............................................................ 2592.7.25. Assay of human plasmin inhibitor............................. 2612.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 261

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 262

2.7.29. Nucleated cell count and viability.............................. 2632.7.2. Microbiological assay of antibiotics............................. 2302.7.30. Assay of human protein C .......................................... 2652.7.31. Assay of human protein S ........................................... 2662.7.32. Assay of human α-1-proteinase inhibitor ................. 2662.7.4. Assay of human coagulation factor VIII ..................... 2362.7.5. Assay of heparin............................................................. 2372.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2372.7.7. Assay of pertussis vaccine (whole cell)........................ 2422.7.8. Assay of tetanus vaccine (adsorbed)............................ 2422.7.9. Test for Fc function of immunoglobulin..................... 2462.7. Biological assays ................................................................ 2292.8.10. Solubility in alcohol of essential oils.......................... 2722.8.11. Assay of 1,8-cineole in essential oils.......................... 2722.8.12. Essential oils in herbal drugs...................................... 2732.8.13. Pesticide residues ......................................................... 2742.8.14. Tannins in herbal drugs .............................................. 2752.8.15. Bitterness value............................................................. 2762.8.16. Dry residue of extracts ................................................ 2762.8.17. Loss on drying of extracts........................................... 2762.8.18. Determination of aflatoxin B1 in herbal drugs ......... 2762.8.1. Ash insoluble in hydrochloric acid .............................. 2712.8.20. Herbal drugs : sampling and sample preparation .... 2782.8.21. Test for aristolochic acids in herbal drugs ................ 2792.8.22. Determination of ochratoxin A in herbal drugs ...... 2812.8.23. Microscopic examination of herbal drugs ................ 2822.8.2. Foreign matter ................................................................ 2712.8.3. Stomata and stomatal index.......................................... 2712.8.4. Swelling index................................................................. 2712.8.5. Water in essential oils .................................................... 2712.8.6. Foreign esters in essential oils ...................................... 2712.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 271

2.8.8. Odour and taste of essential oils .................................. 2722.8.9. Residue on evaporation of essential oils ..................... 2722.8. Methods in pharmacognosy ............................................ 2712.9.10. Ethanol content ............................................................ 3012.9.11. Test for methanol and 2-propanol ............................. 3042.9.12. Sieve test........................................................................ 3052.9.14. Specific surface area by air permeability................... 3052.9.16. Flowability..................................................................... 3072.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 308

2.9.17. Test for extractable volume of parenteral preparations(5.8.) ......................................................................................... 679

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 309

2.9.19. Particulate contamination : sub-visible particles...... 3212.9.19. Particulate contamination : sub-visible particles(5.8.) ......................................................................................... 679

2.9.1. Disintegration of tablets and capsules ......................... 2852.9.1. Disintegration of tablets and capsules (5.8.)............... 678

3606 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0 Index

2.9.20. Particulate contamination : visible particles ............. 3232.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 323

2.9.23. Gas pycnometric density of solids ............................. 3242.9.25. Dissolution test for medicated chewing gums ......... 3252.9.26. Specific surface area by gas adsorption ..................... 3292.9.26. Specific surface area by gas adsorption (5.8.) ........... 6792.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 331

2.9.29. Intrinsic dissolution..................................................... 3312.9.2. Disintegration of suppositories and pessaries ............ 2872.9.31. Particle size analysis by laser light diffraction.......... 3332.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 336

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) ....................... 339

2.9.34. Bulk density and tapped density of powders............ 3432.9.35. Powder fineness............................................................ 3462.9.36. Powder flow .................................................................. 3462.9.36. Powder flow (5.8.) ........................................................ 6792.9.37. Optical microscopy...................................................... 3492.9.37. Optical microscopy (5.8.)............................................ 6792.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 351

2.9.38. Particle-size distribution estimation by analyticalsieving (5.8.) ............................................................................ 679

2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 353

2.9.3. Dissolution test for solid dosage forms ....................... 2882.9.40. Uniformity of dosage units ......................................... 3572.9.41. Friability of granules and spheroids .......................... 3592.9.42. Dissolution test for lipophilic solid dosage forms ... 3612.9.43. Apparent dissolution ................................................... 3612.9.44. Preparations for nebulisation : characterisation....... 3632.9.45. Wettability of porous solids including powders....... 3652.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 368

2.9.4. Dissolution test for transdermal patches .................... 2952.9.5. Uniformity of mass of single-dose preparations ........ 2972.9.6. Uniformity of content of single-dose preparations.... 2982.9.7. Friability of uncoated tablets ........................................ 2982.9.7. Friability of uncoated tablets (5.8.) .............................. 6782.9.8. Resistance to crushing of tablets .................................. 2992.9.9. Measurement of consistency by penetrometry .......... 2992.9. Pharmaceutical technical procedures ............................. 2853.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 395

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration......................................................................... 397

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 375

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 378

3.1.13. Plastic additives ............................................................ 3983.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 401

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 403

3.1.1. Materials for containers for human blood and bloodcomponents ............................................................................. 375

3.1.3. Polyolefins ....................................................................... 3803.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations.. 383

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ................... 384

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ......................... 388

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations .......................... 391

3.1.8. Silicone oil used as a lubricant ..................................... 393

3.1.9. Silicone elastomer for closures and tubing ................. 3943.1. Materials used for the manufacture of containers ........ 3753.2.1. Glass containers for pharmaceutical use..................... 4093.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 414

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 414

3.2.3. Sterile plastic containers for human blood andblood components .................................................................. 415

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 417

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 418

3.2.6. Sets for the transfusion of blood and bloodcomponents ............................................................................. 418

3.2.8. Sterile single-use plastic syringes ................................. 4193.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 421

3.2. Containers.......................................................................... 4093-O-Desacyl-4′-monophosphoryl lipid A............................ 20004.1.1. Reagents .......................................................................... 4254.1.2. Standard solutions for limit tests ................................. 5364.1.3. Buffer solutions .............................................................. 5404.1. Reagents, standard solutions, buffer solutions .............. 4254.2.1. Primary standards for volumetric solutions ............... 5454.2.2. Volumetric solutions...................................................... 5464.2. Volumetric analysis........................................................... 5454-Aminobenzoic acid ............................................................. 15394. Reagents................................................................................. 4255.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 689

5.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 572

5.11. Characters section in monographs ............................... 6955.1.1. Methods of preparation of sterile products ................ 5555.1.2. Biological indicators of sterilisation ............................ 5565.12. Reference standards ........................................................ 6995.1.3. Efficacy of antimicrobial preservation ........................ 5575.14. Gene transfer medicinal products for human use ...... 7055.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use......... 559

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.8.) ......................................................................................... 679

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 560

5.15. Functionality-related characteristics of excipients...... 7195.1.6. Alternative methods for control of microbiologicalquality ...................................................................................... 560

5.16. Crystallinity ..................................................................... 7235.17.1. Recommendations on dissolution testing................. 7275.17. Recommendations on methods for dosage formstesting....................................................................................... 727

5.1.7. Viral safety ...................................................................... 5715.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 571

5.1.9. Guidelines for using the test for sterility..................... 5725.1. General texts on microbiology ........................................ 5555.20. Metal catalyst or metal reagent residues ...................... 7335.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 579

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 579

5.2.3. Cell substrates for the production of vaccines for humanuse............................................................................................. 582

5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 585

5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 587

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 588

General Notices (1) apply to all monographs and other texts 3607

Index EUROPEAN PHARMACOPOEIA 8.0

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 591

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 592

5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 604

5.2. General texts on biological products .............................. 5795.3. Statistical analysis of results of biological assays andtests........................................................................................... 607

5.4. Residual solvents ............................................................... 6395.5. Alcoholimetric tables........................................................ 6495.6. Assay of interferons .......................................................... 6635.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ...................... 667

5.8. Pharmacopoeial harmonisation ...................................... 6775.9. Polymorphism ................................................................... 685

AAbacavir sulfate....................................................................... 1459Abbreviations and symbols (1.) .................................................. 3Abnormal toxicity (2.6.9.)........................................................ 184Absorption spectrophotometry, infrared (2.2.24.) ................. 38Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 40

Acacia ....................................................................................... 1135Acacia, spray-dried ................................................................. 1460Acamprosate calcium ............................................................. 1461Acanthopanax bark ................................................................ 1136Acarbose .................................................................................. 1462Acebutolol hydrochloride ...................................................... 1464Aceclofenac.............................................................................. 1466Acemetacin .............................................................................. 1467Acesulfame potassium............................................................ 1469Acetate trihydrate, sodium .................................................... 3224Acetazolamide......................................................................... 1470Acetic acid, glacial .................................................................. 1471Acetic acid in synthetic peptides (2.5.34.) ............................. 168Acetone .................................................................................... 1472Acetylcholine chloride ........................................................... 1473Acetylcysteine.......................................................................... 1473β-Acetyldigoxin....................................................................... 1475Acetylsalicylic acid ................................................................. 1477Acetyltryptophan, N- ............................................................. 1479Acetyltyrosine, N- ................................................................... 1481Aciclovir................................................................................... 1482Acid value (2.5.1.) ..................................................................... 155Acitretin ................................................................................... 1484Actinobacillosis vaccine (inactivated), porcine .................. 1000Activated charcoal .................................................................. 1839Activated coagulation factors (2.6.22.)................................... 209Adapalene ................................................................................ 1485Additives, plastic (3.1.13.) ....................................................... 398Adenine.................................................................................... 1487Adeno-associated-virus vectors for human use .................... 714Adenosine ................................................................................ 1487Adenovirus vaccine (inactivated), canine.............................. 945Adenovirus vaccine (live), canine........................................... 946Adipic acid............................................................................... 1489Adrenaline ............................................................................... 1490Adrenaline tartrate ................................................................. 1491Adsorption, gas, specific surface area by (2.9.26.)................ 329Adsorption, gas, specific surface area by (2.9.26.) (5.8.) ..... 679Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 309

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 276Agar .......................................................................................... 1136Agnus castus fruit ................................................................... 1137Agrimony................................................................................. 1138Air, medicinal ......................................................................... 1492Air, synthetic medicinal......................................................... 1494Alanine..................................................................................... 1495

Albendazole............................................................................. 1496Albumin solution, human ..................................................... 2404Alchemilla................................................................................ 1139Alcoholimetric tables (5.5.) ..................................................... 649Alcuronium chloride.............................................................. 1497Alendronate, sodium.............................................................. 3225Alexandrian senna pods ........................................................ 1384Alfacalcidol.............................................................................. 1498Alfadex ..................................................................................... 1499Alfentanil hydrochloride ....................................................... 1501Alfuzosin hydrochloride ........................................................ 1502Alginate, sodium..................................................................... 3226Alginic acid.............................................................................. 1503Alimemazine hemitartrate..................................................... 1504Alkaline-earth metals and magnesium (2.4.7.)..................... 128Alkaline impurities in fatty oils (2.4.19.) ............................... 133Allantoin .................................................................................. 1505Allergen products ..................................................................... 741Allopurinol .............................................................................. 1505all-rac-α-Tocopherol............................................................... 3436all-rac-α-Tocopheryl acetate.................................................. 3438Almagate .................................................................................. 1507Almond oil, refined ................................................................ 1508Almond oil, virgin .................................................................. 1509Aloes, Barbados ...................................................................... 1140Aloes, Cape.............................................................................. 1141Aloes dry extract, standardised............................................. 1142Alovudine (18F) injection ....................................................... 1045Alphacyclodextrin .................................................................. 1499Alprazolam .............................................................................. 1509Alprenolol hydrochloride ...................................................... 1511Alprostadil ............................................................................... 1512Alteplase for injection ............................................................ 1515Alternative methods for control of microbiological quality(5.1.6.) ...................................................................................... 560

Altizide..................................................................................... 1518Alum......................................................................................... 1519Aluminium (2.4.17.)................................................................. 132Aluminium chloride hexahydrate......................................... 1519Aluminium hydroxide, hydrated, for adsorption ............... 1520Aluminium in adsorbed vaccines (2.5.13.)............................ 159Aluminium magnesium silicate ............................................ 1521Aluminium oxide, hydrated .................................................. 1522Aluminium phosphate gel ..................................................... 1522Aluminium phosphate, hydrated.......................................... 1523Aluminium sodium silicate ................................................... 1524Aluminium stearate................................................................ 1525Aluminium sulfate.................................................................. 1527Alverine citrate........................................................................ 1527Amantadine hydrochloride ................................................... 1528Ambroxol hydrochloride ....................................................... 1529Amfetamine sulfate ................................................................ 1531Amidotrizoate, sodium .......................................................... 3227Amidotrizoic acid dihydrate ................................................. 1531Amikacin ................................................................................. 1533Amikacin sulfate ..................................................................... 1535Amiloride hydrochloride ....................................................... 1538Amino acid analysis (2.2.56.) .................................................... 90Amino acid analysis (2.2.56.) (5.8.)........................................ 677Aminobenzoic acid, 4- ........................................................... 1539Aminocaproic acid ................................................................. 1540Aminoglutethimide ................................................................ 1541Aminophylline, anhydrous.................................................... 3398Aminophylline hydrate .......................................................... 3399Aminosalicylate dihydrate, sodium...................................... 3228Amiodarone hydrochloride................................................... 1542Amisulpride............................................................................. 1544Amitriptyline hydrochloride ................................................. 1546Amlodipine besilate................................................................ 1547Ammonia (13N) injection....................................................... 1047Ammonia solution, concentrated ......................................... 1548Ammonio methacrylate copolymer (type A)...................... 1549Ammonio methacrylate copolymer (type B) ...................... 1550

3608 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0 Index

Ammonium (2.4.1.).................................................................. 127Ammonium bromide ............................................................. 1551Ammonium chloride.............................................................. 1552Ammonium glycyrrhizate ..................................................... 1552Ammonium hydrogen carbonate ......................................... 1553Amobarbital ............................................................................ 1554Amobarbital sodium .............................................................. 1554Amoxicillin sodium................................................................ 1555Amoxicillin trihydrate............................................................ 1557Amperometric titration (2.2.19.) .............................................. 34Amphotericin B ...................................................................... 1560Ampicillin, anhydrous .......................................................... 1561Ampicillin sodium.................................................................. 1564Ampicillin trihydrate.............................................................. 1566Amylmetacresol ...................................................................... 1568Anaemia vaccine (live), chicken, infectious .......................... 984Anaesthetic ether .................................................................... 2185Analysis, thermal (2.2.34.)......................................................... 55Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 351

Analytical sieving, particle-size distribution estimation by(2.9.38.) (5.8.).......................................................................... 679

Anamirta cocculus for homoeopathic preparations .......... 1442Anastrozole.............................................................................. 1570Angelica archangelica root .................................................... 1142Angelica dahurica root........................................................... 1143Angelica pubescens root ........................................................ 1145Angelica sinensis root ............................................................ 1147Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1575

Animal immunosera for human use ...................................... 748Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 759

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 592

Aniseed .................................................................................... 1150Anise oil ................................................................................... 1148Anisidine value (2.5.36.) .......................................................... 169Antazoline hydrochloride...................................................... 1571Anthrax spore vaccine (live) for veterinary use.................... 921Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 817

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 203Antibiotics, microbiological assay of (2.7.2.) ........................ 230Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 215

Antibodies for human use, monoclonal ................................ 753Anticoagulant and preservative solutions for human blood................................................................................................ 1572

Anticomplementary activity of immunoglobulin (2.6.17.).. 200Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 215

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2407

Anti-D immunoglobulin, human ......................................... 2406Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 249Antimicrobial preservation, efficacy of (5.1.3.) .................... 557Antiserum, European viper venom ...................................... 1033Antithrombin III concentrate, human................................. 2407Antithrombin III, human, assay of (2.7.17.) ......................... 254Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1575

Apomorphine hydrochloride hemihydrate ......................... 1578Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 361Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 560

Aprotinin ................................................................................. 1579Aprotinin concentrated solution .......................................... 1581Arachis oil, hydrogenated...................................................... 1584Arachis oil, refined ................................................................. 1584Arginine ................................................................................... 1585

Arginine aspartate .................................................................. 1586Arginine hydrochloride ......................................................... 1586Argon ....................................................................................... 1587Aristolochic acids in herbal drugs, test for (2.8.21) ............. 279Arnica flower........................................................................... 1151Arnica tincture........................................................................ 1153Arsenic (2.4.2.) .......................................................................... 127Arsenious trioxide for homoeopathic preparations ........... 1443Articaine hydrochloride......................................................... 1588Artichoke leaf .......................................................................... 1154Artichoke leaf dry extract ...................................................... 1156Ascorbate, calcium ................................................................. 1731Ascorbate, sodium.................................................................. 3229Ascorbic acid ........................................................................... 1590Ascorbyl palmitate.................................................................. 1591Ash insoluble in hydrochloric acid (2.8.1.) ........................... 271Ash leaf .................................................................................... 1157Ash, sulfated (2.4.14.)............................................................... 132Ash, sulfated (2.4.14.) (5.8.) .................................................... 678Ash, total (2.4.16.) .................................................................... 132Asparagine monohydrate....................................................... 1592Aspartame................................................................................ 1593Aspartic acid............................................................................ 1594Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 272Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 237Assay of heparin (2.7.5.) .......................................................... 237Assay of heparin in coagulation factors (2.7.12.) ................. 249Assay of hepatitis A vaccine (2.7.14.)..................................... 251Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 252Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 266Assay of human anti-D immunoglobulin (2.7.13.) .............. 249Assay of human antithrombin III (2.7.17.)............................ 254Assay of human coagulation factor II (2.7.18.)..................... 254Assay of human coagulation factor IX (2.7.11.) ................... 248Assay of human coagulation factor VII (2.7.10.).................. 247Assay of human coagulation factor VIII (2.7.4.) .................. 236Assay of human coagulation factor X (2.7.19.) ..................... 255Assay of human coagulation factor XI (2.7.22.) ................... 258Assay of human plasmin inhibitor (2.7.25.) .......................... 261Assay of human protein C (2.7.30.)........................................ 265Assay of human protein S (2.7.31.) ........................................ 266Assay of human von Willebrand factor (2.7.21.) .................. 257Assay of interferons (5.6.)........................................................ 663Assay of pertussis vaccine (acellular) (2.7.16.)...................... 252Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 242Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 255

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 242Assays (2.5.)............................................................................... 155Astragalus mongholicus root ................................................ 1158Atenolol.................................................................................... 1595Atomic absorption spectrometry (2.2.23.) .............................. 36Atomic emission spectrometry (2.2.22.).................................. 35Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) ...................................................................................... 97

Atomoxetine hydrochloride .................................................. 1596Atorvastatin calcium trihydrate ............................................ 1598Atovaquone.............................................................................. 1600Atractylodes lancea rhizome ................................................. 1159Atractylodes rhizome, largehead .......................................... 1160Atracurium besilate ................................................................ 1601Atropine ................................................................................... 1604Atropine sulfate....................................................................... 1605Aujeszky’s disease vaccine (inactivated) for pigs .................. 921Aujeszky’s disease vaccine (live) for pigs for parenteraladministration......................................................................... 923

Aurothiomalate, sodium........................................................ 3230Avian infectious bronchitis vaccine (inactivated)................. 925Avian infectious bronchitis vaccine (live).............................. 926Avian infectious bursal disease vaccine (inactivated) .......... 928Avian infectious bursal disease vaccine (live) ....................... 929Avian infectious encephalomyelitis vaccine (live) ................ 931Avian infectious laryngotracheitis vaccine (live).................. 932

General Notices (1) apply to all monographs and other texts 3609

Index EUROPEAN PHARMACOPOEIA 8.0

Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 212

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) ............................................................................ 995

Avian paramyxovirus 1 (Newcastle disease) vaccine (live).. 997Avian paramyxovirus 3 vaccine (inactivated) for turkeys ... 934Avian tuberculin purified protein derivative....................... 3493Avian viral tenosynovitis vaccine (live) ................................. 935Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 209

Azaperone for veterinary use ................................................ 1607Azathioprine............................................................................ 1608Azelastine hydrochloride ....................................................... 1609Azithromycin .......................................................................... 1610

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 204

Bacampicillin hydrochloride ................................................. 1615Bacitracin................................................................................. 1617Bacitracin zinc......................................................................... 1619Baclofen ................................................................................... 1621Bacterial endotoxins (2.6.14.).................................................. 194Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 572

Baical skullcap root ................................................................ 1161Bambuterol hydrochloride .................................................... 1622Barbados aloes ........................................................................ 1140Barbital..................................................................................... 1623Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1444

Barium sulfate ......................................................................... 1624Basic butylated methacrylate copolymer ............................. 1624BCG for immunotherapy......................................................... 818BCG vaccine, freeze-dried....................................................... 819Bearberry leaf .......................................................................... 1162Beclometasone dipropionate, anhydrous............................. 1626Beclometasone dipropionate monohydrate......................... 1628Bee for homoeopathic preparations, honey ........................ 1449Beeswax, white ........................................................................ 1630Beeswax, yellow....................................................................... 1630Belamcanda chinensis rhizome............................................. 1163Belladonna leaf........................................................................ 1165Belladonna leaf dry extract, standardised ........................... 1166Belladonna leaf tincture, standardised................................. 1167Belladonna, prepared ............................................................. 1168Benazepril hydrochloride ...................................................... 1631Bendroflumethiazide.............................................................. 1633Benperidol ............................................................................... 1633Benserazide hydrochloride .................................................... 1635Bentonite.................................................................................. 1636Benzalkonium chloride.......................................................... 1637Benzalkonium chloride solution........................................... 1638Benzathine benzylpenicillin .................................................. 1647Benzbromarone....................................................................... 1640Benzethonium chloride ......................................................... 1641Benzocaine............................................................................... 1642Benzoic acid ............................................................................ 1643Benzoin, Siam ......................................................................... 1169Benzoin, Siam ......................................................................... 1169Benzoin, Sumatra.................................................................... 1170Benzoin tincture, Siam........................................................... 1171Benzoin tincture, Sumatra..................................................... 1172Benzoyl peroxide, hydrous .................................................... 1643Benzyl alcohol ......................................................................... 1645Benzyl benzoate ...................................................................... 1646Benzylpenicillin, benzathine ................................................. 1647Benzylpenicillin potassium ................................................... 1648Benzylpenicillin, procaine ..................................................... 1650Benzylpenicillin sodium ........................................................ 1651Betacarotene ............................................................................ 1653

Betacyclodextrin ..................................................................... 1653Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2456Betadex..................................................................................... 1653Betahistine dihydrochloride.................................................. 1655Betahistine mesilate................................................................ 1656Betamethasone........................................................................ 1657Betamethasone acetate ........................................................... 1659Betamethasone dipropionate................................................. 1661Betamethasone sodium phosphate....................................... 1663Betamethasone valerate ......................................................... 1664Betaxolol hydrochloride......................................................... 1666Bezafibrate ............................................................................... 1667Bicalutamide............................................................................ 1668Bifonazole ................................................................................ 1670Bilberry fruit, dried ................................................................ 1172Bilberry fruit dry extract, fresh, refined and standardised.. 1250Bilberry fruit, fresh................................................................. 1173Biological assays (2.7.) ............................................................. 229Biological assays and tests, statistical analysis of results of(5.3.) ......................................................................................... 607

Biological indicators of sterilisation (5.1.2.).......................... 556Biological products, general texts on (5.2.) ........................... 579Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 579

Biological tests (2.6.) ................................................................ 175Biotin........................................................................................ 1671Biperiden hydrochloride........................................................ 1672Biphasic insulin injection ...................................................... 2493Biphasic isophane insulin injection...................................... 2493Birch leaf .................................................................................. 1173Bisacodyl .................................................................................. 1673Bismuth subcarbonate............................................................ 1675Bismuth subgallate.................................................................. 1676Bismuth subnitrate, heavy ..................................................... 1676Bismuth subsalicylate ............................................................. 1677Bisoprolol fumarate ................................................................ 1678Bistort rhizome ....................................................................... 1175Bitter fennel ............................................................................. 1241Bitter-fennel fruit oil .............................................................. 1176Bitter-fennel herb oil .............................................................. 1177Bitterness value (2.8.15.) .......................................................... 276Bitter-orange epicarp and mesocarp .................................... 1179Bitter-orange-epicarp and mesocarp tincture..................... 1180Bitter-orange flower................................................................ 1181Bitter-orange-flower oil.......................................................... 1329Black cohosh............................................................................ 1182Blackcurrant leaf ..................................................................... 1186Black horehound..................................................................... 1185Bleomycin sulfate.................................................................... 1680Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 417

Blood and blood components, human, materials for containersfor (3.1.1.) ................................................................................ 375

Blood and blood components, sets for the transfusion of(3.2.6.) ...................................................................................... 418

Blood and blood components, sterile plastic containers for(3.2.3.) ...................................................................................... 415

Blood, anticoagulant and preservative solutions for .......... 1572Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.)........................... 418

Bogbean leaf ............................................................................ 1187Boiling point (2.2.12.) ................................................................ 31Boldo leaf ................................................................................. 1188Boldo leaf dry extract............................................................. 1189Borage (starflower) oil, refined ............................................. 1681Borax ........................................................................................ 1682Bordetella bronchiseptica vaccine (live) for dogs................. 936Boric acid................................................................................. 1682Botulinum antitoxin ............................................................... 1029Botulinum toxin type A for injection .................................. 1683Botulinum toxin type B for injection................................... 1684Bovine insulin ......................................................................... 2486Bovine leptospirosis vaccine (inactivated) ............................ 937

3610 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0 Index

Bovine parainfluenza virus vaccine (live).............................. 938Bovine respiratory syncytial virus vaccine (live) .................. 940Bovine rhinotracheitis vaccine (live), infectious .................. 983Bovine serum .......................................................................... 1686Bovine tuberculin purified protein derivative..................... 3494Bovine viral diarrhoea vaccine (inactivated) ........................ 941Bromazepam ........................................................................... 1687Bromhexine hydrochloride.................................................... 1688Bromocriptine mesilate.......................................................... 1689Bromperidol ............................................................................ 1692Bromperidol decanoate.......................................................... 1693Brompheniramine maleate .................................................... 1695Bronchitis vaccine (inactivated), infectious, avian ............... 925Bronchitis vaccine (live), infectious, avian ............................ 926Brotizolam ............................................................................... 1696Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use.......................................................................... 942

Buccal tablets and sublingual tablets...................................... 795Buckwheat herb ...................................................................... 1190Budesonide .............................................................................. 1697Bufexamac ............................................................................... 1699Buffer solutions (4.1.3.)............................................................ 540Buflomedil hydrochloride...................................................... 1700Bulk density and tapped density of powders (2.9.34.) ......... 343Bumetanide ............................................................................. 1702Bupivacaine hydrochloride.................................................... 1703Buprenorphine ........................................................................ 1705Buprenorphine hydrochloride .............................................. 1706Bursal disease vaccine (inactivated), infectious, avian......... 928Bursal disease vaccine (live), infectious, avian...................... 929Buserelin .................................................................................. 1708Buspirone hydrochloride ....................................................... 1709Busulfan ................................................................................... 1711Butcher’s broom...................................................................... 1192Butylated methacrylate copolymer, basic ............................ 1624Butylhydroxyanisole ............................................................... 1713Butylhydroxytoluene .............................................................. 1714Butyl parahydroxybenzoate................................................... 1712

CCabergoline ............................................................................. 1717Cachets....................................................................................... 781Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1444

Caffeine .................................................................................... 1718Caffeine monohydrate............................................................ 1719Calcifediol................................................................................ 1720Calcipotriol, anhydrous ......................................................... 1722Calcipotriol monohydrate ..................................................... 1724Calcitonin (salmon)................................................................ 1726Calcitriol .................................................................................. 1728Calcium (2.4.3.)......................................................................... 127Calcium acetate, anhydrous .................................................. 1729Calcium ascorbate .................................................................. 1731Calcium carbonate.................................................................. 1731Calcium carboxymethylcellulose .......................................... 1774Calcium chloride dihydrate................................................... 1732Calcium chloride hexahydrate .............................................. 1733Calcium dobesilate monohydrate ......................................... 1733Calcium edetate, sodium ....................................................... 3233Calcium folinate...................................................................... 1734Calcium glucoheptonate ........................................................ 1736Calcium gluconate .................................................................. 1737Calcium gluconate, anhydrous.............................................. 1738Calcium gluconate for injection ........................................... 1739Calcium glycerophosphate .................................................... 1740Calcium hydrogen phosphate, anhydrous ........................... 1740Calcium hydrogen phosphate dihydrate.............................. 1742Calcium hydroxide ................................................................. 1743Calcium in adsorbed vaccines (2.5.14.) ................................. 159Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1444

Calcium lactate, anhydrous ................................................... 1743Calcium lactate monohydrate ............................................... 1744Calcium lactate pentahydrate................................................ 1744Calcium lactate trihydrate ..................................................... 1745Calcium levofolinate pentahydrate....................................... 1745Calcium levulinate dihydrate ................................................ 1748Calcium pantothenate ............................................................ 1749Calcium pentetate (sodium) for radiopharmaceuticalpreparations .......................................................................... 1075

Calcium phosphate ................................................................. 1749Calcium stearate ..................................................................... 1750Calcium sulfate dihydrate...................................................... 1751Calendula flower..................................................................... 1193Calf coronavirus diarrhoea vaccine (inactivated)................. 943Calf rotavirus diarrhoea vaccine (inactivated)...................... 944Calicivirosis vaccine (inactivated), feline .............................. 970Calicivirosis vaccine (live), feline ........................................... 971Camphor, D-............................................................................ 1752Camphor, racemic .................................................................. 1753Candesartan cilexetil .............................................................. 1754Canine adenovirus vaccine (inactivated)............................... 945Canine adenovirus vaccine (live)............................................ 946Canine distemper vaccine (live) ............................................. 947Canine leptospirosis vaccine (inactivated) ............................ 948Canine parainfluenza virus vaccine (live) ............................. 949Canine parvovirosis vaccine (inactivated)............................. 950Canine parvovirosis vaccine (live).......................................... 951Cape aloes................................................................................ 1141Capillary electrophoresis (2.2.47.) ............................................ 79Capillary electrophoresis (2.2.47.) (5.8.) ............................... 677Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3234Caprylic acid ........................................................................... 1756Caprylocaproyl macrogolglycerides ..................................... 1757Capsicum ................................................................................. 1194Capsicum oleoresin, refined and standardised ................... 1196Capsicum soft extract, standardised .................................... 1197Capsicum tincture, standardised .......................................... 1198Capsules ..................................................................................... 779Capsules and tablets, disintegration of (2.9.1.) ..................... 285Capsules and tablets, disintegration of (2.9.1.) (5.8.)........... 678Capsules, gastro-resistant ........................................................ 780Capsules, hard ........................................................................... 780Capsules, intrauterine .............................................................. 787Capsules, modified-release ...................................................... 780Capsules, oromucosal............................................................... 795Capsules, rectal ......................................................................... 806Capsules, soft............................................................................. 780Capsules, vaginal....................................................................... 813Captopril .................................................................................. 1758Caraway fruit........................................................................... 1199Caraway oil .............................................................................. 1200Carbachol................................................................................. 1760Carbamazepine ....................................................................... 1761Carbasalate calcium................................................................ 1762Carbidopa ................................................................................ 1764Carbimazole ............................................................................ 1765Carbocisteine........................................................................... 1766Carbomers ............................................................................... 1766Carbon dioxide ....................................................................... 1768Carbon dioxide in gases (2.5.24.) ........................................... 161Carbon monoxide................................................................... 1769Carbon monoxide (15O) ......................................................... 1048Carbon monoxide in gases (2.5.25.)....................................... 162Carboplatin.............................................................................. 1770Carboprost trometamol ......................................................... 1771Carboxymethylcellulose......................................................... 1773Carboxymethylcellulose calcium.......................................... 1774Carboxymethylcellulose sodium........................................... 1774Carboxymethylcellulose sodium, cross-linked ................... 1969Carboxymethylcellulose sodium, low-substituted.............. 1775Carisoprodol............................................................................ 1772Carmellose............................................................................... 1773

General Notices (1) apply to all monographs and other texts 3611

Index EUROPEAN PHARMACOPOEIA 8.0

Carmellose calcium ................................................................ 1774Carmellose sodium................................................................. 1774Carmellose sodium and microcrystalline cellulose............ 2776Carmellose sodium, low-substituted.................................... 1775Carmustine .............................................................................. 1776Carnauba wax.......................................................................... 1777Carprofen for veterinary use ................................................. 1778Carrageenan ............................................................................ 1779Carteolol hydrochloride......................................................... 1780Carvedilol ................................................................................ 1781Cascara..................................................................................... 1201Cascara dry extract, standardised......................................... 1202Cassia oil .................................................................................. 1203Castor oil, hydrogenated........................................................ 1782Castor oil, polyoxyl................................................................. 2665Castor oil, polyoxyl hydrogenated........................................ 2664Castor oil, refined ................................................................... 1783Castor oil, virgin ..................................................................... 1784Catgut, sterile .......................................................................... 1117Catgut, sterile, in distributor for veterinary use ................. 1127CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 258

Cefaclor.................................................................................... 1785Cefadroxil monohydrate........................................................ 1786Cefalexin monohydrate.......................................................... 1788Cefalotin sodium .................................................................... 1789Cefamandole nafate................................................................ 1791Cefapirin sodium.................................................................... 1792Cefatrizine propylene glycol.................................................. 1793Cefazolin sodium.................................................................... 1794Cefepime dihydrochloride monohydrate ............................ 1796Cefixime................................................................................... 1799Cefoperazone sodium ............................................................ 1800Cefotaxime sodium ................................................................ 1801Cefoxitin sodium .................................................................... 1803Cefpodoxime proxetil ............................................................ 1805Cefprozil monohydrate .......................................................... 1807Cefradine ................................................................................. 1809Ceftazidime pentahydrate...................................................... 1811Ceftazidime pentahydrate with sodium carbonate forinjection ................................................................................. 1813

Ceftriaxone sodium................................................................ 1815Cefuroxime axetil ................................................................... 1817Cefuroxime sodium................................................................ 1818Celandine, greater................................................................... 1268Celecoxib ................................................................................. 1819Celiprolol hydrochloride ....................................................... 1820Cell count and viability, nucleated (2.7.29.).......................... 263Cell cultures for the production of veterinary vaccines(5.2.4.) ...................................................................................... 585

Cell substrates for the production of vaccines for human use(5.2.3.) ...................................................................................... 582

Cellular products, microbiological control of (2.6.27.)........ 216Cellulose acetate ..................................................................... 1822Cellulose acetate butyrate ...................................................... 1823Cellulose acetate phthalate .................................................... 1823Cellulose, microcrystalline .................................................... 1824Cellulose (microcrystalline) and carmellose sodium......... 2776Cellulose, powdered ............................................................... 1828Centaury .................................................................................. 1204Centella .................................................................................... 1205Cetirizine dihydrochloride .................................................... 1831Cetostearyl alcohol ................................................................. 1833Cetostearyl alcohol (type A), emulsifying ........................... 1834Cetostearyl alcohol (type B), emulsifying ........................... 1835Cetostearyl isononanoate ...................................................... 1836Cetostearyl sulfate, sodium ................................................... 3237Cetrimide................................................................................. 1836Cetyl alcohol............................................................................ 1837Cetyl palmitate ........................................................................ 1838Cetylpyridinium chloride ...................................................... 1838Ceylon cinnamon bark oil ..................................................... 1210Ceylon cinnamon leaf oil....................................................... 1211

CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 262

Chamomile flower, Roman ................................................... 1206Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ................... 339

Characterisation of crystalline solids by microcalorimetr