impurities.pdf · code product api / imp unit ref pa 01 01000 acebutolol hydrochloride api 25 mg,...

CODE PRODUCT API / IMP UNIT REF

PA 01 01000 Acebutolol Hydrochloride API 25 MG, 50 MG EP

PA 01 01010 3’-Acetyl-4’-(2,3-epoxypropoxy)-butyranilide ImpA 25 MG, 50 MG EP

PA 01 01020 N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino] propoxy] phenyl] acetamide ("diacetolol")

Imp B 25 MG, 50 MG EP

PA 01 01030 N-(3-Acetyl-4-hydroxyphenyl)butanamide Imp C 25 MG, 50 MG EP

PA 01 01040 1-[5-amino-2-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]ethanone

Imp D 25 MG, 50 MG EP

PA 01 02000 Aceclofenac API 25 MG, 50 MG EP

PA 01 02010 [2-[(2,6-Dichlorophenyl) amino]phenyl]acetic acid (Diclofenac)

Imp. A 25 MG, 50 MG EP

PA 01 02020 Methyl [2-[(2,6-Dichlorophenyl)amino]phenyl]actate (Methyl Ester of Diclofenac)

Imp. B 25 MG, 50 MG EP

PA 01 02030 Ethyl 2-(2[(2,6-dichlorophenyl) amino]phenyl]acetate (Ethyl Ester of Diclofenac)

Imp. C 25 MG, 50 MG EP

PA 01 02040 Methyl[[[2-[2,6-Dichloro-pehnyl)amino)phenyl]acetyl]oxy)-acetate (Methyl Ester of Aceclofenac)

Imp. D 25 MG, 50 MG EP( y )

PA 01 02050 Ethyl[[[2-[2,6-Dichloro-pehnyl)amino)phenyl]acetyl]oxy)-acetate (Eethyl Ester of Aceclofenac)

Imp. E 25 MG, 50 MG EP

PA 01 02060 Benzyl [[[2-(2,6-Dichlorophenyl)amino]phenyl]acetyl] loxy]acetate (Benzyl ester of Aceclofenac)

Imp. F 25 MG, 50 MG EP

PA 01 02070 [[[[[2-(2,6-Dichlorophenyl) amino]phenyl]acetyl] loxy]acetic acid (Acetic Aceclofenac)

Imp. G 25 MG, 50 MG EP

PA 01 02080 [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid ("diacetic aceclofenac")

Imp H 25 MG, 50 MG EP

( )

PA 01 02090 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one Imp. I 25 MG, 50 MG EP

PA 01 03000 Acetazolamide API 25 MG, 50 MG EP

PA 01 04000 Acetylcysteine API 25 MG, 50 MG EP

PA 01 04010 L-Cystine Imp. A 25 MG, 50 MG EP

PA 01 04020 L-Cysteine Imp. B 25 MG, 50 MG EP

PA 01 04040 N,S-Diacetyl-L-Cysteine Imp. D 25 MG, 50 MG EP

PA 01 05000 Acetylsalicylic acid API 25 MG, 50 MG EP

PA 01 05010 4-Hydroxybenzoic acid Imp A 25 MG, 50 MG EP

PA 01 05020 4-Hydroxybenzene-1,3-dicarboxylicacid(4-Hydroxyisophthalic acid

Imp B 25 MG, 50 MG EPHydroxyisophthalic acid

PA 01 05030 Salicylic acid Imp C 25 MG, 50 MG EP

PA 01 05040 Acetylsalicyl Salicylic acid Imp D 25 MG, 50 MG EP

PA 01 05050 Salicylsalicylic acid Imp E 25 MG, 50 MG EP

PA 01 05060 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic Anhydride) Imp F 25 MG, 50 MG EP,

PA 01 06000 Aciclovir API 25 MG, 50 MG EP

PA 01 06020 2-Amino-1,7-dihydro-6H-purin-6-one (Guanine) Imp B 25 MG, 50 MG EP

PA 01 06510 2,6-Dichloropurine IH 25 MG, 50 MG IH

PA 01 07000 Adenosine API 25 MG 50 MG EPPA 01 07000 Adenosine API 25 MG, 50 MG EP

PA 01 08000 Adiphenine Hydrochloride API 25 MG, 50 MG EP

PA 01 09000 Adrenaline Tartrate API 25 MG, 50 MG EP

PA 01 09510 L-Adrenaline IH 25 MG, 50 MG IH

PA 01 09030 1-(3 4-Dihydroxyphenyl)-2-(methylamino)-ethanol Imp C 25 MG 50 MG EPPA 01 09030 1-(3,4-Dihydroxyphenyl)-2-(methylamino)-ethanol Hydrochloride Monohydrate (Adrenalone Hydrochloride Monohydrate)

Imp C 25 MG, 50 MG EP

PA 01 10000 Alanine API 25 MG, 50 MG EP

PA 01 11000 Albendazole API 25 MG, 50 MG EP

PA 01 11010 5-(Propylsulphanyl)-1H-benzimidazol-2-amine Imp A 25 MG 50 MG EPPA 01 11010 5-(Propylsulphanyl)-1H-benzimidazol-2-amine Imp A 25 MG, 50 MG EP

PA 01 11020 Methyl[5-Propylsulphinyl)-1H-benzimidazol-2-yl]carbamate Imp B 25 MG, 50 MG EP

PA 01 11030 Methyl[5-Propylsulphonyl)-1H-benzimidazol-2-yl]carbamate Imp C 25 MG, 50 MG EP

PA 01 11040 5-(Propylsulphonyl)-1H-benzimidazol-2-amine Imp D 25 MG, 50 MG EP

PA 01 11050 Methyl (1H-Benzimidazol-2-yl)carbamate (Carbendazim) Imp E 25 MG, 50 MG EP

PA 01 12000 Alfuzosin Hydrochloride API 25 MG, 50 MG EP

PA 01 12010 N-[3-[(4-amino-6,7-dimethoxy-quinazolin-2-yl) Imp A 25 MG, 50 MG EPmethylamino]propyl]furan-2-carboxamide

,

PA 01 12020 2-Chloro-6, 7-dimethoxyquinazolin-4-amine Imp B 25 MG, 50 MG EP

PA 01 12030 (RS)-N-[3-[(4-amino-6,7-dimethoxy-quinazolin-2-yl)amino]propyl]-N-methyltetrahydrofuran- 2-carboxamide


PA 01 12040 N-(4-amino-6,7-dimethoxyquinazolin-2-yl)-N-methylpropane-1,3-diamine


PA 01 12050 N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)methylamino]propyl]formamide

Imp E 25 MG, 50 MG EP

PA 01 13000 Allobarbital API 25 MG, 50 MG EP

PA 01 14000 Allopurinol API 25 MG 50 MG EPPA 01 14000 Allopurinol API 25 MG, 50 MG EP

PA 01 14010 5-Amino-1H-pyrazole-4-carboxamide Hemisulphate Imp. A 25 MG, 50 MG EP

PA 01 14020 Allopurinol Imp B 25 MG, 50 MG EP

PA 01 14030 Allopurinol Imp C 25 MG, 50 MG EP

PA 01 14040 Allopurinol Imp D 25 MG, 50 MG EP

PA 01 14050 Allopurinol Imp E 25 MG, 50 MG EP

PA 01 15000 Alprazolam API 25 MG, 50 MG EP

PA 01 15050 (2-Amino-5-chlorophenyl)-phenylmethanone Imp. E 25 MG, 50 MG EP

PA 01 16000 Alverine Citrate API 25 MG, 50 MG EP

PA 01 16010 1-Chloro-3-phenylpropane Imp. A 25 MG, 50 MG EP

PA 01 16020 3-Phenylpropan-1-ol Imp. B 25 MG, 50 MG EP

PA 01 16030 N-Ethyl-3-phenylpropan-1-amine Hydrochloride Imp. C 25 MG, 50 MG EP

PA 01 16040 N-Ethyl-3-phenylpropan-1-amine Hydrochloride Imp. D 25 MG 50 MG EPPA 01 16040 N-Ethyl-3-phenylpropan-1-amine Hydrochloride Imp. D 25 MG, 50 MG EP

PA 01 16050 3-Phenyl-N,N-bis(3-phenylpropyl)propan-1-amine Hydrochloride


PA 01 17000 Amantadine Hydrochloride API 25 MG, 50 MG EP

PA 01 18000 Ambroxol Hydrochloride API 25 MG, 50 MG EP

PA 01 18010 (2-amino-3,5-dibromophenyl)methanol Imp A 25 MG, 50 MG EPPA 01 18010 (2 amino 3,5 dibromophenyl)methanol Imp A 25 MG, 50 MG EP

PA 01 18020 trans-4-(6,8-dibromo-1,4-dihydroquinazolin-3(2H)-yl)cyclohexanol


PA 01 18030 trans-4-[[(E)-2-amino-3,5-dibromobenzyliden]amino]cyclohexanol


PA 01 18040 cis-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Imp D 25 MG, 50 MG EP

PA 01 18050 2-Amino-3,5-dibromobenzaldehyde Imp. E 25 MG, 50 MG EP

PA 01 18510 Ambroxol Acid Metabolite IH 25 MG, 50 MG IH

PA 01 18520 trans-4-Aminocyclohexanol Hydrochloride IH 25 MG, 50 MG IH

PA 01 18530 cis-4-Aminocyclohexanol Hydrochloride IH 25 MG, 50 MG IH

PA 01 18540 Amiloride Hydrochloride Dihydrate IH 25 MG, 50 MG IH

PA 01 19000 Amiodarone Hydrochloride API 25 MG, 50 MG EP

PA 01 19010 (2-Butylbenzo-furan-3-yl)[4-[2-(diethylamino)ethoxy]-phenyl]methanone Oxalate


PA 01 19020 (2-Butylbenzo-furan-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-di-iodophenyl]methanone Hydrochloride (Desethylamiodarone


Hydrochloride)

PA 01 19030 (2-Butylbenzofuran-3-yl)[4-[2-(diethylamino)ethoxy]-3-iodophenyl]methanone ("Monodesiodo Amiodarone")


PA 01 19040 (2-Butylbenzofuran-3-yl)(4-hydroxy-3,5-diiodophenyl)methanone

Imp. D 25 MG, 50 MG EP

PA 01 19050 (2-Butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone Imp. E 25 MG, 50 MG EP

PA 01 19060 (2-Butylbenzofuran-3-yl)(4-hydroxy-3-iodophenyl)methanone

Imp F 25 MG, 50 MG EP

PA 01 19070 [2-[(1RS)-1-Methoxybutyl]benzofuran-3-yl][4-[2-(diethylamino)ethoxy] 3 5 diiodophenyl] methanone

Imp G 25 MG, 50 MG EP(diethylamino)ethoxy]-3,5-diiodophenyl] methanone ("Methoxy Amiodarone")

PA 01 19080 2-Chloro-N,N-diethylethanamine Hydrochloride Imp. H 25 MG, 50 MG EP

PA 01 19510 N,N-Di-Desethyl Amiodarone ( "Metabolite")

(2-Butylbenzofuran-3-yl)[4-[2-aminoethoxy]-3,5-

IH 25 MG, 50 MG IH

(2-Butylbenzofuran-3-yl)[4-[2-aminoethoxy]-3,5-diiodophenyl]methanone

PA 01 19520 Amiodarone N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 01 20000 Amisulpride API 25 MG, 50 MG EP

PA 01 20010 [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine Imp. A 25 MG, 50 MG EP

PA 01 21000 Amitraz API 25 MG, 50 MG EP

PA 01 21010 2,4-Dimethylaniline (2,4-Xylidine) Imp. A 25 MG, 50 MG EP

PA 01 22000 Amitriptyline Hydrochloride API 25 MG, 50 MG EP

PA 01 22010 10,11-Dihydro-5H-dibenzo-[a,d][7]annulen-5-one (Dibenzosuberone)

Imp. A 25 MG, 50 MG EP(Dibenzosuberone)

PA 01 22020 3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine Hydrochloride(Cyclobenzaprine Hydrochloride)


PA 01 22030 3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1-amineHydrochloride (Nortriptyline Hydrochloride)


PA 01 22040 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-ol


PA 01 22070 10,11-Dihydro-5H-dibenzo[a,d][7]-annulen-5-ol (Dibenzosuberol)


PA 01 22510 Amitriptyline N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 01 22520 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene (Dibenzosuberane)

IH 25 MG, 50 MG IH

PA 01 23000 Amlodipine Besilate API 25 MG, 50 MG EP

PA 01 23050 N,N-dimethyl-3(1,2,3,4,4a,10,11,11a-octahydro-5H-dibenzo[a d][7]annulen 5 ylidene)propan 1 amine

Imp E 25 MG, 50 MG EPdibenzo[a,d][7]annulen-5-ylidene)propan-1-amine

PA 01 23060 Dimethyl (4R)-2-[(2-Aminoethoxy)methyl]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate


PA 01 23070 Dimethyl 4-(2-Chlorophenyl)-2,6-dimethyl-1,4-dihydro-pyridine-3,5-dicarboxylate

Imp G 25 MG, 50 MG EP

PA 01 23080 2-[[2-[[(4R)-4-(2-Chlorophenyl)-3-(ethoxycarbonyl)-5- Imp H 25 MG, 50 MG EP[[ [[( ) ( p y ) ( y y )(methoxycarbonyl)-6-methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]carbamoyl]benzoic Acid

p 25 MG, 50 MG

PA 01 24000 Amlodipine API 25 MG, 50 MG EP

PA 01 24010 3-Ethyl 5-methyl 4-(2-chlorophenyl)-2-[[2-(1,3-dioxo- 1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-1,4- dihydropyridine-3 5-dicarboxylate

Imp A 25 MG, 50 MG EP

dihydropyridine-3,5-dicarboxylate

PA 01 24020 3-Ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-[[2- [[2-(methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4- dihydropyridine-3,5-dicarboxylate


PA 01 24030 Ethyl methyl 2,6-bis[(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


PA 01 24040 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-6-methylpyridine-3,5-dicarboxylate


PA 01 24050 3-Ethyl 5-ethyl 4-(2-chlorophenyl)-6-methyl-2-[[2- [(2-aminoethoxy)methyl]-1,4-dihydropyridine-3,5-dicarboxylate


PA 01 24060 3-Methyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-[[2- [(2-aminoethoxy)methyl] 1 4 dihydropyridine 3 5 dicarboxylate

Imp F 25 MG, 50 MG EPaminoethoxy)methyl]-1,4-dihydropyridine-3,5-dicarboxylate

PA 01 24070 3-Ethyl 5-methyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate


PA 01 24080 3-Ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-[2-[(2-carboxybenzoyl) amino ethoxy)]methyl]-1,4-dihydropyridine-3,5-dicarboxylate


PA 01 24510 Benzenesulfonic Acid IH 25 MG, 50 MG IH

PA 01 25000 Amlodipine Maleate API 25 MG, 50 MG EP

PA 01 26000 Amlodipine Mesilate API 25 MG, 50 MG EP

PA 01 27000 Amodiaquine Dihydrochloride Dihydrate API 25 MG, 50 MG EP

PA 01 28000 Amoxicillin Trihydrate API 25 MG, 50 MG EP

PA 01 28010 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylicAcid (6-Aminopenicillanic Acid)


PA 01 28030 (4S)-2-[5-(4-hydroxyphenyl)-3,6-dioxopiperazin-2-yl]-5,5- Imp C 25 MG, 50 MG EPdimethylthiazolidine-4-carboxylic acid (diketopiperazine of amoxycillin)

PA 01 28040 (2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]carboxymethyl]-5,5-dimethylthiazolidine-4-carboxylic acid (penicilloic acids of amoxicillin)


PA 01 28090 (2R) 2 A i 2 (4 h d h l) ti A id I I EPPA 01 28090 (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid Imp. I 25 MG, 50 MG EP

PA 01 28510 (2R)-2-Amino-2-(4-hydroxyphenyl) acetamide IH 25 MG, 50 MG IH

PA 01 29000 Ampicillin Sodium API 25 MG, 50 MG EP

PA 01 29010 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid

Imp. A 25 MG, 50 MG EPy [ ] p y

(6-Aminopenicillanic Acid)

PA 01 30000 Androstanolone API 25 MG, 50 MG EP

PA 01 31000 Antazoline Hydrochloride API 25 MG, 50 MG EP

PA 01 31510 N-Benzylaniline IH 25 MG, 50 MG IH

PA 01 31520 2-Chloromethyl-4,5-dihydro-1H-imidazoleHydrochloride IH 25 MG, 50 MG IH

PA 01 32000 Antazoline Phosphate API 25 MG, 50 MG EP

PA 01 33000 Apomorphine Hydrochloride Hemihydrate API 25 MG, 50 MG EP

PA 01 34000 Aprindine Hydrochloride API 25 MG, 50 MG EP

PA 01 35000 Arginine API 25 MG, 50 MG EP

PA 01 36000 Arginine Hydrochloride API 25 MG, 50 MG EP

PA 01 37000 Articaine Hydrochloride API 25 MG, 50 MG EP

PA 01 37010 Methyl 3-[[2-(Propylamino)acetyl]amino]-4-methyl-thiophene-2-carboxylate Hydrochloride (Acetamidoarticaine Hydrochloride)


PA 01 37030 1-Methyl-ethyl 4-Methyl-3-[[(2RS)-2-(propylamino)-propanoyl]amino]thiophene-2-carboxylateHydrochloride (Articaine Isopropyl EsterHydrochloride)


PA 01 37040 Methyl 3-[[(2RS)-2-(Ethylamino)propanoyl]amino]-4-methylthiophene-2-carboxylateHydrochloride (Ethylarticaine Hydrochloride)


(Ethylarticaine Hydrochloride)

PA 01 37050 Methyl 4-Methyl-3-[[(2RS)-2-[(1-methylethyl)amino]-propanoyl]amino]thiophene-2-carboxylateHydrochloride (IsopropylarticaineHydrochloride)


PA 01 37070 Methyl3-[[(2RS)-2-(Butylamino)propanoyl]amino]-4-methylthiophene 2 carboxylate Hydro chloride

Imp. G 25 MG, 50 MG EPmethylthiophene-2-carboxylate Hydro-chloride (Butylarticaine Hydrochloride)

PA 01 37090 Methyl 3-Amino-4-methylthiophene-2-carboxylate (3-Aminoarticaine)

Imp. I 25 MG, 50 MG EP

PA 01 38000 L-Ascorbic Acid API 25 MG, 50 MG EP

PA 01 39000 Aspartame API 25 MG, 50 MG EP

PA 01 39010 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic acid Imp A 25 MG, 50 MG EP

PA 01 39020 L-Aspartyl-L-phenylalanine Imp. B 25 MG, 50 MG EP

PA 01 39030 L-Phenylalanine ; (S)-2-Amino-3-phenylpropionic acid Imp. C 25 MG, 50 MG EP

PA 01 40000 Aspartic Acid API 25 MG, 50 MG EP

PA 01 41000 Astemizole API 25 MG, 50 MG EP

PA 01 41510 Desmethyl temizole Hydrochloride IH 25 MG, 50 MG IH

PA 01 42000PA 01 42000 Ampicillin Trihydrate API 25 MG, 50 MG EP

PA 01 42030 (4S)-2-(3,6-dioxo-5-phenylpiperazin-2-yl)-5,5- dimethylthiazolidine-4-carboxylic acid(diketopiperazine of ampicillin)


PA 01 42040 (4S)-2-[[[(2R)-2-amino-2-phenylacetyl]amino] carboxymethyl]-5,5-dimethylthiazolidine-4-carboxylic acid


(penicilloic acids of ampicillin)

PA 01 43000 Atenolol API 25 MG, 50 MG EP

PA 01 43010 2-(4-Hydroxyphenyl)-acetamide Imp. A 25 MG, 50 MG EP

PA 01 43020 2-[4-[(2RS)-2,3-Dihydroxy-propoxy]phenyl]acetamide Imp. B 25 MG, 50 MG EP

PA 01 43030 2-[4-[[(2RS)-oxiran-2-yl]methoxy]phenyl]acetamide Imp C 25 MG 50 MG EPPA 01 43030 2-[4-[[(2RS)-oxiran-2-yl]methoxy]phenyl]acetamide Imp C 25 MG, 50 MG EP

PA 01 43040 2-[4-[(2RS)-3-Chloro-2- hydroxypropoxy]phenyl]acetamide IMP.D 25 MG, 50 MG EP

PA 01 43510 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]-acetamide IH 25 MG, 50 MG IH

PA 01 43050 2 2' [2 hydroxypropan 1 3 diylbis(oxy 4 1 Imp E 25 MG 50 MG EPPA 01 43050 2,2'-[2-hydroxypropan-1,3-diylbis(oxy-4,1-phenylene)]diacetamide


PA 01 43060 2,2'-[[(1-Methylethyl)-imino]bis[(2-hydroxypropane-3,1-diyl)oxy-4,1-phenylene]]diacetamide


PA 01 43070 2-[4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]-acetic acid

Imp G 25 MG, 50 MG EPy y ) ]p p y]p y ]

PA 01 43080 2-[4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]-acetonitrile

Imp. H 25 MG, 50 MG EP

PA 01 43520 4-Hydroxyphenylacetic Acid IH 25 MG, 50 MG IH

PA 01 44000 Atorvastatin Calcium API 25 MG, 50 MG EP

PA 01 44510 Atorvastatin Lactone IH 25 MG, 50 MG IH

PA 01 45000 Atracurium Besilate API 25 MG, 50 MG EP

PA 01 45100 Methyl Benzenesulphonate Imp. J 25 MG, 50 MG EP

PA 01 46000 Atropine API 25 MG, 50 MG EP0 6000 Atropine API 5 G, 50 G EP

PA 01 46030 (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) Imp. C 25 MG, 50 MG EP

PA 01 46510 Atropic Acid IH 25 MG, 50 MG IH

PA 01 47000 Avobenzone API 25 MG, 50 MG EP

PA 01 48000 Acebrophylline API 25 MG, 50 MG EP

PA 01 48010 (2-amino-3,5-dibromophenyl)methanol Imp A 25 MG, 50 MG EP

PA 01 48020 trans-4-(6,8-dibromo-1,4-dihydroquinazolin-3(2H)-yl)cyclohexanol


PA 01 48030 trans-4-[[(E)-2-amino-3,5-dibromobenzyliden]amino]cyclohexanol


PA 01 48040 cis-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol {"cis Ambroxol")


PA 01 48050 2-amino-3,5-dibromobenzaldehyde Imp E 25 MG, 50 MG EP

PA 01 48510 Ambroxol Hydrochloride IH 25 MG, 50 MG IH

PA 01 48520 3,5-Dibromoanthranilic acid ("DBAA"); 2-amino-3,5-dibromobenzoic acid

IH 25 MG, 50 MG IH

PA 01 48530 Acefylline; Theophylline-7-acetic acid ("TAA") IH 25 MG, 50 MG IH

PA 01 48540 Acefylline Piperazine IH 25 MG, 50 MG IH

PA 01 49000 Anidulafungin API 25 MG, 50 MG EP

PA 01 49510 Echinocandin B IH 25 MG, 50 MG EP

PA 01 49520 Echinocandin B Nucleus IH EP

PA 01 50000 Aripiprazole 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone

API 25 MG, 50 MG EP

dihydro-2(1H)-quinolinone

PA 01 50510 Aripiprazole-d8 IH 26 MG, 50 MG EP

PA 01 51000 Aztreonam (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid

API 25 MG, 50 MG EP

PA 01 51510 Aztreonam Disodium (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid Disodium Salt

IH 25 MG, 50 MG IH

PA 01 51520 Aztreonam E-Isomer (E) 2 [[[(2 A i 4 thi l l)[[(2S 3S) 2 th l 4 1

IH 25 MG, 50 MG IH(E)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid

PA 01 52000 Atorvastatin Acid API 25 MG, 50 MG

PA 01 52510 Atorvastatin Sodium IH 25 MG, 50 MG IH

PA 01 52520 Atorvastatin Calcium Trihydrate IH 25 MG, 50 MG IH

PA 01 52530 3-Oxo-Atorvastatin IH 25 MG, 50 MG IH

PA 01 52540 5-Oxo-Atorvastatin IH 25 MG, 50 MG IH

PA 01 52550 5-Oxo-Atorvastatin Sodium IH 25 MG, 50 MG IH

PA 01 52560 2-Hydroxy Atorvastatin Calcium IH 25 MG, 50 MG IH

PA 01 52570 2-Hydroxy Atorvastatin Sodium IH 25 MG, 50 MG IH

PA 01 52580 4-Hydroxy Atorvastatin Calcium IH 25 MG, 50 MG IH

PA 01 52590 Hydroxy Atorvastatin Lactone IH 25 MG, 50 MG IH

PA 01 52600 4-Hydroxy Atorvastatin Lactone IH 25 MG, 50 MG IH

PA 01 52610 Atorvastatin Ethyl Ester IH 25 MG, 50 MG IH

PA 01 52620 Atorvastatin Methyl Ester IH 25 MG, 50 MG IH

PA 01 52010 (3R,5R)-7-[3-(Phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1Hpyrrol-1-yl]-3,5-dihydroxyheptanoic acid sodium salt

Imp A 25 MG, 50 MG EPy y y y

(" Desfluoro Atorvastatin Sodium Salt ")

PA 01 52020 3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (" 3-epi-Atorvastatin "; " (3S,5R)-Atorvastatin ")


PA 01 52030 (3R 5R) 7 [3 (Ph l b l) 4 5 bi (4 fl h l) 2 I C EPPA 01 52030 (3R,5R)-7-[3-(Phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, sodium salt (" Difluoro Atorvastatin Sodium Salt ")


PA 01 52040 3-(4-Fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide (" Atorvastatin Epoxide "; " ATV-FXA1 ")


PA 01 52050 (3S,5S)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (" ent-Atorvastatin "; "(3S,5S)-Atorvastatin ")


PA 01 52060 ("Atorvastatin Amide Acid Sodium Salt"; "Atorvastatin Diamino Impurity Sodium Salt")


PA 01 52070 (" 3-O-Methyl Atorvastatin Sodium Salt ") Imp G 25 MG, 50 MG EP

PA 01 52080 5-(4-Fluorophenyl)-1-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-carboxamide (" Atorvastatin Lactone ")


PA 01 52090 tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl)acetate (" Atorvastatin Acetonide t-Butyl Ester "; " L1 ")

Imp I 25 MG, 50 MG USP

PA 01 52630 Atorvastatin t-Butyl Ester IH 25 MG, 50 MG IH

PA 01 52640 4-(4-Fluorophenyl)-2,4-dihydroxy-2-isopropyl-N,5-diphenyl-3 6 di bi l [3 1 0]h 1 b id

IH 25 MG, 50 MG USP3,6-dioxabicyclo [3.1.0]hexane-1-carboxamide(" Atorvastatin Photo Degradation Product ATV-FXA2 ")

PA 01 52650 Atorvastatin Dehydro Ethyl Ester Atorvastatin 3-Deoxy-Hept-2-Enoic Acid Ethyl Ester

IH 25 MG, 50 MG IH

PA 01 52660 (S,E)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) 1H pyrrol 1 yl] 5 hydroxyhept 2 enoic

IH 25 MG, 50 MG USP(phenylcarbamoyl)-1H- pyrrol-1-yl]-5-hydroxyhept-2-enoic acid sodium salt (" Atorvastatin Dehydro Acid Sodium Salt ")

PA 01 52670 Atorvastatin Dehydro Lactone ; IH 25 MG, 50 MG IH

PA 02 02000 Benperidol API 25 MG, 50 MG EP

PA 02 02010 1-(Piperin-4-yl)-1,3-dihdro-2H-benzimidazol-2-one Imp. A 25 MG, 50 MG EP

PA 02 02510 4-chloro-4’-fluorobutyrophenone IH 25 MG, 50 MG IH

PA 02 03000 Benzalkonium Chloride API 25 MG, 50 MG EP

PA 02 03010 Benzyl Alcohol Imp. A 25 MG, 50 MG EP

PA 02 04000 Benzbromarone API 25 MG, 50 MG EP

PA 02 05000 Benzocaine API 25 MG, 50 MG EP

PA 02 05510 N-Acetylbenzocaine IH 25 MG, 50 MG IH

PA 02 05520 4-Aminobenzoic Acid IH 25 MG, 50 MG IH

PA 02 05530 Ethyl 4-Nitrobenzoate IH 25 MG, 50 MG IH

PA 02 06000 Benzydamine Hydrochloride API 25 MG, 50 MG EP

PA 02 06030 1-Benzyl-1H-indazol-3-ol Imp. C 25 MG, 50 MG EP

PA 02 06510 Benzydamine N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 02 06520 1-Chloropropy(dimethyl)amine Hydrochloride (N,N-Dimethyl-3-chloropropylamine Hydrochloride)

IH 25 MG, 50 MG IH

PA 02 07000 B l Al h l API 2 G 0 G EPPA 02 07000 Benzyl Alcohol API 25 MG, 50 MG EP

PA 02 07020 Cyclohexylmethanol Imp. B 25 MG, 50 MG EP

PA 02 08000 Benzyl Benzoate API 25 MG, 50 MG EP

PA 02 09000 Benzyl Nicotinate API 25 MG, 50 MG EP

PA 02 09510 Nicotinic Acid IH 25 MG, 50 MG IH,

PA 02 10000 Benzylpenicillin Benzathine API 25 MG, 50 MG EP

PA 02 10010 Monobenzylethylendiamine Imp. A 25 MG, 50 MG EP

PA 02 10020 Phenylacetic Acid Imp. B 25 MG, 50 MG EP

PA 02 11000 Benzylpenicillin Potsium API 25 MG, 50 MG EP

PA 02 11010 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid (6-aminopenicillanic acid)


PA 02 11020 Phenylacetic acid Imp. B 25 MG, 50 MG EP

PA 02 12000 Benzylpenicillin procaine API 25 MG, 50 MG EP

PA 02 12010 4-Aminobenzoic acid Imp. A 25 MG, 50 MG EP

PA 02 12050 Phenylacetic acid Imp. E 25 MG, 50 MG EP

PA 02 13000 Betahistine Dihydrochloride API 25 MG, 50 MG EPPA 02 13000 Betahistine Dihydrochloride API 25 MG, 50 MG EP

PA 02 13010 2-Ethenylpyridine (2-Vinylpyridine) Imp. A 25 MG, 50 MG EP

PA 02 13020 2-(Pyridin-2-yl)ethanol (2-(2-Hydroxyethyl)pyridine) Imp. B 25 MG, 50 MG EP

PA 02 13030 N-Methyl-2-(pyridine-2-yl)-N-[2-(pyridine-2-yl ethyl]ethanamine Trihydrochloride

Imp. C 25 MG, 50 MG EPethyl]ethanamine Trihydrochloride

PA 02 14000 Betamethone API 25 MG, 50 MG EP

PA 02 14020 21-Chloro-9-fluoro-11β, 17-dihydroxy-16 β-methylpregna-1, 4-diene-3, 20-dione (Clobetol)


PA 02 15000 Betamethone Acetate API 25 MG, 50 MG EP

PA 02 15010 Betametone Imp. A 25 MG, 50 MG EP

PA 02 16000 Betamethone Dipropionate API 25 MG, 50 MG EP

PA 02 16010 Betametone Imp. A 25 MG, 50 MG EP

PA 02 16050 Beclometone Dipropionate Imp E 25 MG 50 MG EPPA 02 16050 Beclometone Dipropionate Imp. E 25 MG, 50 MG EP

PA 02 17000 Betamethone Sodium Phosphate API 25 MG, 50 MG EP

PA 02 17510 Betamethone 17-Valerate IH 25 MG, 50 MG IH

PA 02 17010 Betamethone Imp. A 25 MG, 50 MG EP

PA 02 18000 Betaxolol Hydrochloride API 25 MG, 50 MG EP

PA 02 18010 (2RS)-1-(4- Ethylphenoxy)-3-[(1-methylethyl)amino]- propan-2-ol Hydrochloride


PA 02 18020 (2RS)-1-[4-(2-Hydroxyethyl)- phenoxy]-3-[(1-methylethyl)amino]propan-2-ol


PA 02 18510 2-[[4-[2-(Cyclopropylmethoxy)-ethyl]phenoxy]methyl]oxirane IH 25 MG, 50 MG IH,

PA 02 19000 Bezafibrate API 25 MG, 50 MG EP

PA 02 19010 4-Chloro-N-[2-(4-hydroxyphenyl)ethyl] benzamide (4-Chlorobenzoyltyramine)


PA 02 19020 4-Chlorobenzoic acid Imp B 25 MG 50 MG EPPA 02 19020 4-Chlorobenzoic acid Imp. B 25 MG, 50 MG EP

PA 02 19030 Methyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2- methylpropanoate


PA 02 19040 Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]-ethyl]phenoxy]-2-methylpropanoate


PA 02 19510 Tyramine IH 25 MG, 50 MG IH

PA 02 20000 Bifonazole API 25 MG, 50 MG EP

PA 02 20030 1H-Imidazole (Imidazole) Imp. C 25 MG, 50 MG EP

PA 02 21000 Bisacodyl API 25 MG 50 MG EPPA 02 21000 Bisacodyl API 25 MG, 50 MG EP

PA 02 21010 4,4’-(Pyridin-2-ylmethylene)diphenol Imp. A 25 MG, 50 MG EP

PA 02 22000 Bisoprolol API 25 MG, 50 MG EP

PA 02 23000 Bisoprolol Fumarate API 25 MG, 50 MG EP

PA 02 23010 (RS) 1 (4 Hydroxymethyl phenoxy) 3 isopropylaminopropan Imp A 25 MG 50 MG EPPA 02 23010 (RS)-1-(4-Hydroxymethyl-phenoxy)-3-isopropylaminopropan-2-ol


PA 02 23020 RS)-1-Isopropylamino-3-[4-(2-propoxyethoxymethyl) phenoxy] propan-2-ol ("Bisoprolol Propyl Analog")


PA 02 23030 (RS)-1-[4-[4-(2-Hydroxy-3-isopropopylaminopropoxy)-benzyl]phenoxy]- 3-isopropylaminopropan-2-ol

Imp C 25 MG, 50 MG EPbenzyl]phenoxy]- 3-isopropylaminopropan-2-ol

PA 02 23070 (2RS)-1-[4-(((2-Isopropoxy-ethoxy)methoxy)methyl)phenoxy]-3- (isopropyl-amino)-2-propanol


PA 02 23100 (2RS)-3-[4-((2-Isopropoxyethoxy)methyl)phenoxy]-1,2-propanediol

Imp J 25 MG, 50 MG EP

PA 02 23110 2 I th l 4 [[(2RS) 2 H d 3 I K EPPA 02 23110 2-Isopropoxyethyl 4-[[(2RS)-2-Hydroxy-3-(isopropylamino)propyl]oxy]-benzoate (Bisoprolol Ester)

Imp. K 25 MG, 50 MG EP

PA 02 23120 4-[((2RS)-2-Hydroxy-3-(isopropylamino)-propyl)oxy]benzaldehyde Hydrochloride

Imp L 25 MG, 50 MG EP

PA 02 23130 4-[(2-Isopropoxyethoxy)methyl]phenol Imp M 25 MG, 50 MG EP,

PA 02 23140 (2RS)-1-[4-((2-Ethoxyethoxy)methyl)phenoxy]- 3-(isopropylamino)-2-propanol

Imp N 25 MG, 50 MG EP

PA 02 23170 (2RS)-1-Isopropylamino-3-[4-(2-methoxyethoxy)methyl]-phenoxy-2-propanol

Imp Q 25 MG, 50 MG EP

PA 02 23180 (2RS)-1-(Isopropylamino)-3-(4- methylphenoxy)propan-2-ol Imp R 25 MG 50 MG EPPA 02 23180 (2RS)-1-(Isopropylamino)-3-(4- methylphenoxy)propan-2-ol Imp. R 25 MG, 50 MG EP

PA 02 23190 4-Hydroxybenzaldehyde Imp. S 25 MG, 50 MG EP

PA 02 23510 4-Hydroxybenzyl Alcohol IH 25 MG, 50 MG IH

PA 02 23520 Fumaric Acid IH 25 MG, 50 MG IHPA 02 23520 Fumaric Acid IH 25 MG, 50 MG IH

PA 02 24000 Boldenone API 25 MG, 50 MG EP

PA 02 25000 Bromazepam API 25 MG, 50 MG EP

PA 02 26000 Bromhexine Hydrochloride API 25 MG, 50 MG EP

PA 02 26010 2-Amino-3,5-dibromophenyl)methanol Imp. A 25 MG, 50 MG EP

PA 02 26020 2-Amino-3,5-dibromobenzaldehyde Imp. B 25 MG, 50 MG EP

PA 02 26030 N-(2-Aminobenzyl)-N-methylcyclohexanamine Imp. C 25 MG, 50 MG EP

PA 02 26510 N-(2-Nitrobenzyl)-N-cyclohexyl-N-methylamine IH 25 MG, 50 MG IHPA 02 26510 N (2 Nitrobenzyl) N cyclohexyl N methylamine IH 25 MG, 50 MG IH

PA 02 26520 Bromhexine N-Oxide IH 25 MG, 50 MG IH

PA 02 27000 Bromisoval API 25 MG, 50 MG EP

PA 02 27510 Ethyl 2-Bromoisovalerate IH 25 MG, 50 MG IH

PA 02 28000 Brompheniramine Maleate API 25 MG, 50 MG EP

PA 02 28010 Chlorphenamine Maleate Imp. A 25 MG, 50 MG EP

PA 02 28030 (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)propan-1-amine (Pheniramine)


PA 02 28510 Brompheniramine N Oxide IH 25 MG 50 MG IHPA 02 28510 Brompheniramine N-Oxide IH 25 MG, 50 MG IH

PA 02 28520 Desmethylbrompheniramine Maleate IH 25 MG, 50 MG IH

PA 02 29000 Buclizine Hydrochloride API 25 MG, 50 MG EP

PA 02 29010 1,4-Bis(4-chlorobenzhydryl)piperazine(1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine)

Imp. A 25 MG, 50 MG EPchlorophenyl)phenylmethyl]piperazine)

PA 02 29510 4-Chlorobenzhydrol IH 25 MG, 50 MG IH

PA 02 29520 4-Chlorobenzophenone IH 25 MG, 50 MG IH

PA 02 29530 1-(4-Chlorobenzhydryl)piperazine((RS)-1-[(4-Chlorophenyl)phenylmethyl]-piperazine)

IH 25 MG, 50 MG IHChlorophenyl)phenylmethyl]-piperazine)

PA 02 30000 Budesonide API 25 MG, 50 MG EP

PA 02 30010 11,16,17,21-Tetrahydroxy-pregna-1,4-diene-3,20-dione (16-Hydroxy-prednisolone)


PA 02 30020 16 17 [(1RS) th lid bi ( )] 11b 21 dih d I B 2 G 0 G EPPA 02 30020 16a,17-[(1RS)-ethylidenebis(oxy)]-11b,21-dihydroxypregna-1,4-diene-3,20-dione


PA 02 30040 16a,17-[(1RS)-butylidenebis(oxy)]-11b-hydroxy-3,20-dioxopregna-1,4-dien-21-al


PA 02 31000 Bufexamac API 25 MG, 50 MG EP

PA 02 31010 2-(4-Butoxyphenyl)acetic Acid Imp. A 25 MG, 50 MG EP

PA 02 31020 Methyl 2-(4-Butoxyphenyl)-acetate Imp. B 25 MG, 50 MG EP

PA 02 31030 Butyl 2-(4-Butoxyphenyl)-acetate Imp. C 25 MG, 50 MG EP

PA 02 31040 2 (4 B t h l) t id I D 25 MG 50 MG EPPA 02 31040 2-(4-Butoxyphenyl)acetamide Imp. D 25 MG, 50 MG EP

PA 02 31510 4'-Butoxyacetophenone IH 25 MG, 50 MG IH

PA 02 31520 Ethyl 2-(4-Butoxyphenyl)acetate IH 25 MG, 50 MG IH

PA 02 32000 Buflomedil Hydrochloride API 25 MG, 50 MG EP

PA 02 32510 4-(1-Pyrrolidino)butyronitrile IH 25 MG, 50 MG IH

PA 02 32520 1,3,5-Trimethoxybenzene IH 25 MG, 50 MG IH

PA 02 33000 Bunolol Hydrochloride API 25 MG, 50 MG EP

PA 02 34000 Buphenine Hydrochloride API 25 MG 50 MG EPPA 02 34000 Buphenine Hydrochloride API 25 MG, 50 MG EP

PA 02 35000 Bupivacaine Hydrochloride Monohydrate API 25 MG, 50 MG EP

PA 02 35010 N-(2,6-Dimethylphenyl)pyridine-2-carboxamide Imp. A 25 MG, 50 MG EP

PA 02 35510 Bupivacaine N-Oxide IH 25 MG, 50 MG IH

PA 02 36000 Bupropion Hydrochloride API 25 MG, 50 MG EP

PA 02 36510 3-Chloropropiophenone IH 25 MG, 50 MG IH

PA 02 36010 [2-(tert-butylamino)-4'-chloropropiophenone hydrochloride Imp A 25 MG, 50 MG USP

PA 02 36020 2-(tert-butylamino)-3'-bromopropiophenone hydrochloride Imp B 25 MG, 50 MG USP

PA 02 36030 1-(3-chlorophenyl)-2-hydroxy-1-propanone Imp C 25 MG, 50 MG USP

PA 02 36040 2-(tert-butylamino)propiophenone hydrochloride; Deschloro Bupropion Hydrochloride

Imp D 25 MG, 50 MG USP

PA 02 36050 1-(3-Chlorophenyl)-1,2-propanedione Imp E 25 MG, 50 MG USP

PA 02 36060 1-(3-chlorophenyl)-1-hydroxy-2-propanone Imp F 25 MG, 50 MG USP

PA 02 36520 Bupropion 2'-Chloro Analog

2-(tert-Butylamino)-2'-chloropropiophenone hydrochloride

IH 25 MG, 50 MG IH

2-(tert-Butylamino)-2 -chloropropiophenone hydrochloride

PA 02 36530 Bupropion Des-t-Butylamino Impurity

3'-Chloropropiophenone

IH 25 MG, 50 MG IH

PA 02 36540 Bupropion 2-Bromo Impurity IH 25 MG, 50 MG IH

2-Bromo-3'-chloropropiophenone

PA 02 36550 Bupropion 3',4'-Dichloro Impurity

2-(tert-Butylamino)-3',4'-chloropropiophenone hydrochloride

IH 25 MG, 50 MG IH

PA 02 36560 Bupropion 3',5'-Dichloro Impurity IH 25 MG, 50 MG IH

2-(tert-Butylamino)-3',5'-chloropropiophenone hydrochloride

PA 02 36570 Bupropion Amino Impurity (HCL Salt)

(±)-2-Amino-3'-chloropropiophenone hydrochloride

IH 25 MG, 50 MG IH

PA 02 36580 upropion Morpholinol Impurity (HCL Salt)

(2S,3S)-2-(3-Chlorophenyl)-3,5,5-trimethyl-2-morpholinol hydrochloride ;

IH 25 MG, 50 MG IH

hydrochloride ; (2S,3S)-Hydroxybupropion hydrochloride; Radafaxine hydrochloride

PA 02 37000 Buspirone Hydrochloride API 25 MG, 50 MG EP

PA 02 37010 Di2-(Piperazin-1-yl)pyrimidine Dihydrochloride Imp. A 25 MG, 50 MG EP

PA 02 37110 8-Azpiro[4,5]decane-7,9-dione Imp. K 25 MG, 50 MG EP

PA 02 38000 Butetamate Citrate API 25 MG, 50 MG EP

PA 02 39000 Butyl Parahydroxybenzoate API 25 MG, 50 MG EP

PA 02 39010 4-Hydroxybenzoic Acid Imp A 25 MG 50 MG EPPA 02 39010 4-Hydroxybenzoic Acid Imp. A 25 MG, 50 MG EP

PA 02 39020 Methyl 4-Hydroxybenzoate(Methyl Parahydroxybenzoate) Imp. B 25 MG, 50 MG EP

PA 02 39030 Ethyl 4-Hydroxybenzoate(Ethyl Parahydroxybenzoate) Imp. C 25 MG, 50 MG EP

PA 02 39040 Propyl 4-Hydroxybenzoate(Propyl Parahydroxybenzoate) Imp. D 25 MG, 50 MG EP

PA 02 39050 2-Methylpropyl 4-Hydroxybenzoate (Isobutyl Para-hydroxybenzoate)


PA 02 40000 Butylhydroxytoluene API 25 MG, 50 MG EP

PA 02 41000 Bicalutamide API 25 MG, 50 MG EP

PA 02 41510 Bicalutamide Sulfoxide IH 25 MG, 50 MG IH

PA 02 41520 Bicalutamide Sulfide IH 25 MG, 50 MG IH

PA 02 41530 Bicalutamide R-Isomer IH 25 MG, 50 MG IH

PA 02 41540 Bicalutamide S-Isomer IH 25 MG, 50 MG IH

PA 02 41550 Bicalutamide Desfluoro Impurity IH 25 MG, 50 MG IH

PA 02 41560 Bicalutamide 2-Fluoro Isomer IH 25 MG, 50 MG IH

PA 02 41570 Bicalutamide Deshydroxy Impurity IH 25 MG 50 MG IHPA 02 41570 Bicalutamide Deshydroxy Impurity IH 25 MG, 50 MG IH

PA 02 42000 Benzenesulfonic Acid Butyl Ester ; Butyl Benzenesulfonate ; Butyl Besylate (Genotoxic Impurity).

API 25 MG, 50 MG EP

PA 02 42510 Benzenesulfonic Acid Ethyl Ester ; Ethyl Benzenesulfonate ; Ethyl Besylate (Genotoxic Impurity).

IH 25 MG, 50 MG IH

PA 02 42520 Benzenesulfonic Acid Isopropyl Ester ; Isopropyl Benzenesulfonate ; Benzenesulfonic Acid 1-Methylethyl Ester ; Isopropyl Besylate (Genotoxic Impurity).

IH 25 MG, 50 MG IH

PA 02 42530 Benzenesulfonic Acid Methyl Ester ; Methyl Benzenesulfonate ; Methyl Besylate (Genotoxic Impurity).

IH 25 MG, 50 MG IH

PA 02 43000 Bendamustine API 25 MG, 50 MG EP

PA 02 43510 Bendamustine Methyl Ester IH 25 MG, 50 MG IH

PA 02 43520 Bendamustine Ethyl Ester IH 25 MG, 50 MG IH

PA 02 43530 Bendamustine Isopropyl Ester IH 25 MG, 50 MG IH

PA 02 43540 Bendamustine Dihydroxy Impurity IH 25 MG, 50 MG IH

PA 03 01000 Caffeine API 25 MG, 50 MG EP

PA 03 01010 Theophylline Imp A 25 MG 50 MG EPPA 03 01010 Theophylline Imp. A 25 MG, 50 MG EP

PA 03 01030 1,3,9-Trimethyl-3,9-dihydro-1H-purine-2,6-dione (Isocaffeine)


PA 03 01040 Theobromine Imp. D 25 MG, 50 MG EP

PA 03 01060 1 7-Dimethyl-3 7-dihydro-1H-purine-2 6-dione Imp F 25 MG 50 MG EPPA 03 01060 1,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione (Paraxanthine; 1,7-Dimethylxanthine)


PA 03 02000 Captopril API 25 MG, 50 MG EP

PA 03 02010 (2S,2�S)-1,1�-[disulphanediylbis[(2S)-2-methyl-1- oxopropane-3,1-diyl]-bis[pyrrolidine-2-carboxylic] acid (captopril-disulphide)


( p p p )

PA 03 02510 Captopril Acid Impurity IH 25 MG, 50 MG IH

PA 03 02520 Captopril Acid Amine Salt IH 25 MG, 50 MG IH

PA 03 02530 Captopril S-Methyl Metabolite IH 25 MG, 50 MG IH

PA 03 02540 Captopril S-Methyl Sulfoxide IH 25 MG, 50 MG IH

PA 03 03000 Carbamazepine API 25 MG, 50 MG EP

PA 03 03010 10,11-Dihydro-5H-dibenzo[b,f]-azepine-5-carboxamide (10,11-Dihydro-carbamazepine)


PA 03 03020 9-Methylacridine Imp. B 25 MG, 50 MG EP

PA 03 03040 5H-Dibenzo[b,f]azepine (Iminostilbene) IMP D 25 MG, 50 MG EP

PA 03 03050 10,11-Dihydro-5H-dibenzo[b,f]- azepine (Iminodibenzyl) IMP E 25 MG, 50 MG EP

PA 03 03510 Oxcarbazepine IH 25 MG 50 MG IHPA 03 03510 Oxcarbazepine IH 25 MG, 50 MG IH

PA 03 04000 Carbalate Calcium API 25 MG, 50 MG EP

PA 03 04010 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic Anhydride) Imp. A 25 MG, 50 MG EP

PA 03 04020 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid (A t l li l li li A id)

Imp. B 25 MG, 50 MG EP(Acetylsalicylsalicylic Acid)

PA 03 04030 2-Hydroxybenzoic Acid (Salicylic Acid) Imp. C 25 MG, 50 MG EP

PA 03 04040 2-[(2-Hydroxybenzoyl)oxy]-benzoic Acid (Salicylsalicylic Acid)


PA 03 05000 Carbenicillin Sodium API 25 MG 50 MG EPPA 03 05000 Carbenicillin Sodium API 25 MG, 50 MG EP

PA 03 06000 Carbocisteine API 25 MG, 50 MG EP

PA 03 06510 L-Cysteinesulfinic Acid IH 25 MG, 50 MG IH

PA 03 07000 Carvedilol API 25 MG, 50 MG EP

PA 03 07010 1-[[9-[2-hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]-9H-carbazol-4-yl]oxy]-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol ;

Imp A EP

PA 03 07020 1,1'-[[2-(2-Methoxyphenoxy)ethyl]-nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol]

Imp. B 25 MG, 50 MG EPy y)p p ]

PA 03 07030 (2RS)-1-[Benzyl[2-(2-methoxy-phenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy)propan-2-ol


PA 03 07040 Toluene Imp. D 25 MG, 50 MG EP

PA 03 07510 4 (2 3 Epoxypropoxy)carbazole IH 25 MG 50 MG IHPA 03 07510 4-(2,3-Epoxypropoxy)carbazole IH 25 MG, 50 MG IH

PA 03 07520 2-(2-Methoxyphenoxy)ethylamineHydrochloride IH 25 MG, 50 MG IH

PA 03 07530 Carvedilol (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

IH 25 MG, 50 MG IH

PA 03 07540 Carvedilol R-Isomer (2R)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

IH 25 MG, 50 MG IH

PA 03 07550 Carvedilol S-Isomer (2S)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

IH 25 MG, 50 MG IH

PA 03 07040 Carvedilol 4-(2,3-Epoxypropoxy)carbazole ; Carvedilol Epoxide Impurity


PA 03 07050 Carvedilol 2-(2-Methoxyphenoxy)ethylamine Hydrochloride ; Carvedilol Amine Impurity

Imp E 25 MG, 50 MG USP

PA 03 08000 Cefaclor Monohydrate API 25 MG, 50 MG EP

PA 03 08010 (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine) Imp. A 25 MG, 50 MG EP

PA 03 08020 (6R,7R)-7-amino-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid


PA 03 08030 (6R,7R)-7-[[(2S)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid ("Cefaclor 2S-Isomer")


PA 03 08060 3-Phenylpyrazin-2-ol Imp. F 25 MG, 50 MG EP

PA 03 09000 Cefadroxil Monohydrate API 25 MG, 50 MG EPPA 03 09000 Cefadroxil Monohydrate API 25 MG, 50 MG EP

PA 03 09010 (2R)-2-Amino-2-(4-hydroxyphenyl)-acetic Acid Imp. A 25 MG, 50 MG EP

PA 03 09020 (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicAcid (7-ADCA; 7-Aminodesacetoxycephalosporanic Acid)


PA 03 10000 Cefalexin Monohydrate API 25 MG, 50 MG EP

PA 03 10010 (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine) Imp. A 25 MG, 50 MG EP

PA 03 10020 (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicAcid (7-Aminodesacetoxycephalosporanic Acid;7 ADCA)


Aminodesacetoxycephalosporanic Acid;7-ADCA)

PA 03 11000 Cefazolin Sodium API 25 MG, 50 MG EP

PA 03 11050 5-Methyl-1,3,4-thiadiazol-2-thiol (MMTD) Imp. E 25 MG, 50 MG EP

PA 03 11080 (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)


PA 03 12000 Cefetamet API 25 MG, 50 MG EP

PA 03 12510 7-Aminodesacetoxycephalosporanic Acid IH 25 MG, 50 MG IH

PA 03 13000 Cefoprezone Sodium API 25 MG, 50 MG EP

PA 03 13030 1-Methyl-1H-tetrazole-5-thiol Imp. C 25 MG, 50 MG EP

PA 03 14000 Cefradine API 25 MG, 50 MG EP

PA 03 14010 (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-Aminodeacetoxycephalosporanic Acid 7-ADCA)


Aminodeacetoxycephalosporanic Acid, 7-ADCA)

PA 03 15000 Celiprolol Hydrochloride API 25 MG, 50 MG EP

PA 03 15010 1-[5-Amino-2-[(2RS)-3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]-phenyl]ethanone


PA 03 15040 3-[3-Acetyl-4-[(2RS)-3-(diethylamino)-2- Imp D 25 MG 50 MG EPPA 03 15040 3-[3-Acetyl-4-[(2RS)-3-(diethylamino)-2-hydroxypropoxy]phenyl]-1,1-diethylurea


PA 03 15060 3-(3-Acetyl-4-hydroxyphenyl)-1,1-diethylurea Imp. F 25 MG, 50 MG EP

PA 03 15510 3-Acetyl-4-hydroxyaniline Hydrochloride IH 25 MG, 50 MG IH

PA 03 15520 5-Acetamido-2-hydroxyacetophenone IH 25 MG, 50 MG IHy y p 25 MG, 50 MG

PA 03 16000 Cetirizine Dihydrochloride API 25 MG, 50 MG EP

PA 03 16010 (RS)-1-[(4-Chlorophenyl)-phenylmethyl]piperazine Imp. A 25 MG, 50 MG EP

PA 03 16020 (RS) 2 [4 [(4 Chlorophenyl)phenylmethyl] piperazin 1 Imp B 25 MG 50 MG EPPA 03 16020 (RS)-2-[4-[(4-Chlorophenyl)phenylmethyl]-piperazin-1-yl]acetic Acid Dihydrochloride


PA 03 16030 (RS)-2-[2-[4-[(2-Chlorophenyl)phenylmethyl]-piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride


PA 03 16040 1,4-Bis[(4-chlorophenyl)-phenylmethyl]piperazine Imp. D 25 MG, 50 MG EP

PA 03 16050 (RS)-2-[2-[2-[4-[(4-Chlorophenyl)phenyl-methyl]piperazin-1-yl]ethoxy]ethoxy]-acetic Acid Dihydrochloride(Ethoxycetirizine Dihydrochloride)


PA 03 16060 [2-[4-(Diphenylmethyl)piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride


PA 03 16070 2-[4-[(RS)-(4-Chlorophenyl)phenylmethyl]-piperazin-1-yl]ethanol Dihydrochloride


PA 03 16510 Isopropyl Ester of Cetirizine IH 25 MG, 50 MG IH

PA 03 16520 4-Chlorobenzhydrol IH 25 MG, 50 MG IH

PA 03 16530 4-Chlorobenzophenone IH 25 MG, 50 MG IH

PA 03 16540 Cetirizine N-Oxide IH 25 MG, 50 MG IH

PA 03 16550 Ethyl Ester of Cetirizine Dihydrochloride IH 25 MG, 50 MG IH

PA 03 16560 Methyl Ester of Cetirizine Dihydrochloride IH 25 MG, 50 MG IHPA 03 16560 Methyl Ester of Cetirizine Dihydrochloride IH 25 MG, 50 MG IH

PA 03 17000 Chlorambucil API 25 MG, 50 MG EP

PA 03 18000 Chloramphenicol API 25 MG, 50 MG EP

PA 03 18510 (D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3-propanediol IH 25 MG, 50 MG IH

PA 03 19000 Chlordiazepoxide Hydrochloride API 25 MG, 50 MG EP

PA 03 19010 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide(Demoxepam)


PA 03 19030 (2-Amino-5-chlorophenyl)phenyl-methanone (Aminochlorobenzophenone)


PA 03 20000 Chlorhexidine Diacetate API 25 MG, 50 MG EP

PA 03 20510 4-Chloroaniline IH 25 MG, 50 MG IH

PA 03 20520 (4-Chlorophenyl)urea IH 25 MG, 50 MG IH

PA 03 21000 Chlorhexidine Dihydrochloride API 25 MG, 50 MG EP

PA 03 22000 Chlormezanone API 25 MG, 50 MG EP

PA 03 22510 4-Chlorobenzaldehyde IH 25 MG, 50 MG IH

PA 03 23000 Chlorobutanol Hemihydrate API 25 MG, 50 MG EPPA 03 23000 Chlorobutanol Hemihydrate API 25 MG, 50 MG EP

PA 03 24000 Chlorocresol API 25 MG, 50 MG EP

PA 03 25000 Chlorphenamine Maleate API 25 MG, 50 MG EP

PA 03 25010 2-(4-Chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile Dihydrochloride


PA 03 25020 N-(Pyridin-2-yl)pyridin-2-amine(2,2'-Dipyridylamine) Imp. B 25 MG, 50 MG EP

PA 03 25030 (3RS)-3-(4-Chloro-phenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine Maleate


PA 03 25040 (2RS)-2-(4-Chloro-phenyl)-4-(dimethylamino)-2-(pyridin-2-yl)butanenitrile Maleate


PA 03 25510 Chlorphenamine N-Oxide Dihydrochloride IH 25 MG, 50 MG IH

PA 03 26000 Chlorpromazine Hydrochloride API 25 MG, 50 MG EP

PA 03 26010 3-(2-Chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine S-Oxide (Chlorpromazine Sulphoxide)

Imp. A 25 MG, 50 MG EPamine S Oxide (Chlorpromazine Sulphoxide)

PA 03 26030 Promazine Hydrochloride Imp. C 25 MG, 50 MG EP

PA 03 26040 3-(2-Chloro-10H-phenothiazin-10-yl)-N-methylpropan-1-amine Hydrochloride (Desmethylchlorpromazine Hydrochloride)


PA 03 26050 2-Chloro-10H-phenothiazine Imp. E 25 MG, 50 MG EPPA 03 26050 2 Chloro 10H phenothiazine Imp. E 25 MG, 50 MG EP

PA 03 27000 Cimetidine API 25 MG, 50 MG EP

PA 03 27010 3-cyano-2-methyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]sulphanyl]ethyl]isothiourea


PA 03 28000 Chlorquinaldol API 25 MG, 50 MG EPq ,

PA 03 29000 Chlortalidone API 25 MG, 50 MG EP

PA 03 30000 Chlortetracycline Hydrochloride API 25 MG, 50 MG EP

PA 03 31000 Ciclopirox Olamine API 25 MG, 50 MG EP

PA 03 31030 6-Cyclohexyl-4-methylpyridin-2(1H)-one Imp. C 25 MG, 50 MG EPPA 03 31030 6 Cyclohexyl 4 methyl pyridin 2(1H) one Imp. C 25 MG, 50 MG EP

PA 03 32000 Cimetidine Hydrochloride API 25 MG, 50 MG EP

PA 03 32010 3-Cyano-2-methyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]-sulphanyl]ethyl]isothiourea


PA 03 32050 2-Cyano-1-methyl-3-[2-[[(5-methyl-1H-imidazol-4-l) th l] l hi l] th l] idi (Ci tidi S l h id )

Imp. E 25 MG, 50 MG EPyl)methyl]sulphinyl]-ethyl]guanidine(Cimetidine Sulphoxide)

PA 03 32510 Cyanoguanidine IH 25 MG, 50 MG IH

PA 03 33000 Cinchocaine Hydrochloride API 25 MG, 50 MG EP

PA 03 33020 2-Hydroxyquinoline-4-carboxylic Acid Imp. B 25 MG, 50 MG EP

PA 03 33510 Cinchocaine N-Oxide IH 25 MG, 50 MG IH

PA 03 34000 Cinnarizine API 25 MG, 50 MG EP

PA 03 34010 1-(Diphenylmethyl)piperazine Imp. A 25 MG, 50 MG EP

PA 03 34020 (Z)-1-(Diphenylmethyl)-4-(3-phenylprop-2-enyl)piperazine Imp. B 25 MG, 50 MG EP

PA 03 34030 (4-(Diphenylmethyl)-1,1-bis[(E)- 3-phenylprop-2-enyl]piperazinium Chloride


PA 03 34040 1-(Diphenylmethyl)-4-[(1RS,3E)-4-phenyl-1-[(E)-2-phenylethenyl]but-3-enyl]-piperazine

Imp D 25 MG, 50 MG EPphenylethenyl]but-3-enyl]-piperazine

PA 03 34050 1,4-Bis(diphenylmethyl)piperazine Imp. E 25 MG, 50 MG EP

PA 03 35000 Ciprofloxacin Hydrochloride API 25 MG, 50 MG EP

PA 03 35010 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Fluoroquinolonic Acid)

Imp. A 25 MG, 50 MG EP3 carboxylic Acid (Fluoroquinolonic Acid)

PA 03 35020 1-Cyclopropyl-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid (Desfluoro Compound)


PA 03 35030 7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid(Ethylenediamine Compound)


Compound)

PA 03 35040 7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid

Imp D 25 MG, 50 MG

PA 03 35050 1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-quinolin-4(1H)-one(Decarboxylated Compound)


PA 03 36000 Citalopram Hydrobromide API 25 MG, 50 MG EP

PA 03 36010 (1RS)-1-[3-(Dimethylamino)-propyl]-1-(4-fluorophenyl)-1,3-dihydro-isobenzofuran-5-carboxamide (Citalopram-Amide)


PA 03 36030 (3RS)-6-Cyano-3-[3-(dimethyl-amino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one

Imp. C 25 MG, 50 MG EPfluorophenyl)isobenzofuran-1(3H)-one

PA 03 36040 (1RS)-1-(4- Fluorophenyl)-1-[3-(methylamino)propyl]-1,3- dihydroisobenzofuran-5-carbonitrile Hydro- chloride (Desmethylcitalopram Hydrochloride)

IMP D 25 MG, 50 MG EP

PA 03 36070 4-(dimethylamino)-1-[(1R)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-yl]butan-1-one


PA 03 37000 Citric Acid Anhydrous API 25 MG, 50 MG EP

PA 03 38000 Clarithromycin API 25 MG, 50 MG EP

PA 03 38040 N-Desmethyl clarithromycin Imp D 25 MG, 50 MG EP

PA 03 38080 N-Formyl clarithromycin Imp H 25 MG, 50 MG EPPA 03 38080 N Formyl clarithromycin Imp H 25 MG, 50 MG EP

PA 03 39000 Clonazepam API 25 MG, 50 MG EP

PA 03 39010 (2-amino-5-nitrophenyl)(2-chlorophenyl)methanone Imp A 25 MG, 50 MG EP

PA 03 39020 3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one Imp B 25 MG, 50 MG EP

PA 03 40000 Citric Acid Monohydrate API 25 MG, 50 MG EP

PA 03 41000 Clioquinol API 25 MG, 50 MG EP

PA 03 41010 5-Chloroquinolin-8-ol IMP A 25 MG, 50 MG EP

PA 03 41020 5 7 Dichloroquinolin 8 ol Imp B 25 MG 50 MG EPPA 03 41020 5,7-Dichloroquinolin-8-ol Imp. B 25 MG, 50 MG EP

PA 03 41030 5,7-Diiodoquinolin-8-ol Imp. C 25 MG, 50 MG EP

PA 03 42000 Clomifene Citrate API 25 MG, 50 MG EP

PA 03 42510 Clomifene N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 03 42520 Desethylclomifene Hydrochloride IH 25 MG, 50 MG IH

PA 03 43000 Clomipramine Hydrochloride API 25 MG, 50 MG EP

PA 03 43020 Imipramine Hydrochloride IMP B 25 MG, 50 MG EP

PA 03 43050 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl) IMP E 25 MG, 50 MG EP

PA 03 43060 3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepine IMP F 25 MG, 50 MG EP

PA 03 43070 3-Chloro-5-(prop-2-enyl)-10,11-dihydro-5H-dibenzo[b,f]azepine

IMP G 25 MG, 50 MG EP

PA 03 43510 Desmethylclomipramine Hydrochloride IH 25 MG, 50 MG IH

PA 03 43520 Clomipramine N-Oxide IH 25 MG, 50 MG IH

PA 03 44000 Clonidine Hydrochloride API 25 MG, 50 MG EP

PA 03 44030 2,6-Dichloroaniline IMP C 25 MG, 50 MG EP

PA 03 45000 Clopidogrel Hydrogen Sulphate API 25 MG, 50 MG EP

PA 03 45010 [(+)-(S)-(o-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetic acid hydrochloride (" Clopidogrel Acid Hydrochloride ")

Imp A 25 MG, 50 MG USP

PA 03 45020 Methyl (±) (o chlorophenyl) 4 5 dihydrothieno[2 3 c]pyridine I B 25 MG 50 MG USPPA 03 45020 Methyl (±)-(o-chlorophenyl)-4,5-dihydrothieno[2,3-c]pyridine-6(7H)-acetate hydrochloride ("Clopidogrel Thieno Isomer Racemate")

Imp B 25 MG, 50 MG USP

PA 03 45030 Methyl (-)-(R)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate hydrogen sulfate ("Clopidogrel R-Isomer")

Imp C 25 MG, 50 MG USP

PA 03 45510 Clopidogrel Bisulfate Racemate IH 25 MG, 50 MG USP

PA 03 45520 Clopidogrel Acid Racemate IH 25 MG, 50 MG IH

PA 03 45530 Clopidogrel Acid R-Isomer IH 25 MG, 50 MG IH

PA 03 45540 (RS)-(o-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetonitrile

IH 25 MG, 50 MG IH

PA 03 45550 Clopidogrel TTP Impurity 4,5,6,7-Tetrahydrothieno[3,2-c] pyridine hydrochloride ("TTP")

IH 25 MG, 50 MG IH

PA 03 46000 Clotrimazole API 25 MG, 50 MG EPPA 03 46000 Clotrimazole API 25 MG, 50 MG EP

PA 03 46030 1-Chloro-2-(chlorodi-phenylmethyl)benzene IMP C 25 MG, 50 MG EP

PA 03 46040 Imidazole IMP D 25 MG, 50 MG EP

PA 03 46050 (2-Chlorophenyl)phenyl-methanone (2-Chlorobenzophenone)

IMP E 25 MG, 50 MG EP(2 Chlorobenzophenone)

PA 03 47000 Cloxacillin Sodium Monohydrate API 25 MG, 50 MG EP

PA 03 47010 [3-(2-chlorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic acid (penilloic acids of cloxacillin)


PA 03 47030 (2S 5R 6R)-6-Amino-3 3-dimethyl-7-oxo-4-thia-1- IMP C 25 MG 50 MG EPPA 03 47030 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)

IMP C 25 MG, 50 MG EP

PA 03 47040 3-(2-Chlorophenyl)-5-methyl-isoxazole-4-carboxylic Acid IMP D 25 MG, 50 MG EP

PA 03 48000 Cloxiquine API 25 MG, 50 MG EP

PA 03 49000 Clozapine API 25 MG, 50 MG EP

PA 03 49010 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one


PA 03 49020 11,11'-(Piperazine-1,4-diyl)bis(8-chloro-5H-dibenzo[b,e][1,4]-diazepine)


PA 03 49030 8-Chloro-11-(piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine Imp. C 25 MG, 50 MG EP

PA 03 49510 Codeine Phosphate Hemihydrate IH 25 MG, 50 MG IH

PA 03 49520 Codeine N-Oxide IH 25 MG, 50 MG IH

PA 03 49530 Codeinone IH 25 MG, 50 MG IH

PA 03 50000 Colchicine API 25 MG, 50 MG EP

PA 03 51000 Cortisone API 25 MG, 50 MG EP

PA 03 52000 Cortisone Acetate API 25 MG, 50 MG EP

PA 03 52010 Hydrocortisone Acetate Imp. A 25 MG, 50 MG EP

PA 03 53000 Cyclizine Hydrochloride API 25 MG, 50 MG EP

PA 03 53020 Diphenylmethanol (Benzhydrol) Imp. B 25 MG, 50 MG EP

PA 03 54000 Cyclobenzaprine Hydrochloride API 25 MG, 50 MG EP

PA 03 55000 Cyclopentolate Hydrochloride API 25 MG, 50 MG EP

PA 03 55010 (2RS)-(1-Hydroxycyclopentyl)-(phenyl)acetic Acid Imp. A 25 MG, 50 MG EP

PA 03 55020 Phenylacetic Acid Imp. B 25 MG, 50 MG EP

PA 03 55030 2-(Dimethyl-amino)ethyl Phenylacetate Hydrochloride Imp. C 25 MG, 50 MG EPPA 03 55030 2 (Dimethyl amino)ethyl Phenylacetate Hydrochloride Imp. C 25 MG, 50 MG EP

PA 03 56000 Cynarine API 25 MG, 50 MG EP

PA 03 56510 3,4-Dihydroxycinnamic Acid (Caffeic Acid) IH 25 MG, 50 MG IH

PA 03 57000 Cyproheptadine Hydrochloride Sesquihydrate API 25 MG, 50 MG EP,

PA 03 57010 5H-Dibenzo[a,d][7]annulene (Dibenzocycloheptene) Imp. A 25 MG, 50 MG EP

PA 03 57020 10,11-Dihydro-5H-dibenzo[a,d][7]- annulen-5-one (Dibenzosuberone)

Imp.B 25 MG, 50 MG EP

PA 03 57030 5-(1-Methyl- piperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5- ol Hydrochloride

Imp.C 25 MG, 50 MG EP

PA 03 57510 5H-Dibenzo[a,d]cyclohepten-5-one (Dibenzosuberenone) IH 25 MG, 50 MG IH

PA 03 57520 Demethylcyproheptadine Hydrochloride IH 25 MG, 50 MG IH

PA 03 57530 Cyproheptadine -α-N-Oxide IH 25 MG, 50 MG IH

PA 03 58000 Camptothecin API 25 MG, 50 MG EP

PA 03 58510 7-Ethyl Camptothecin IH 25 MG, 50 MG IH

PA 03 58520 7-Ethyl-10-Hydroxy Camptothecin IH 25 MG, 50 MG IH

PA 03 58530 10-Hydroxy Camptothecin IH 25 MG, 50 MG IH

PA 03 58540 Irinotecan Hydrochloride Trihydrate IH 25 MG, 50 MG IH

PA 03 58550 Topotecan Hydrochloride IH 25 MG, 50 MG IH

PA 03 59000 Candesartan API 25 MG, 50 MG EP

PA 03 59510 C d t Cil til IH 25 MG 50 MG IHPA 03 59510 Candesartan Cilexetil IH 25 MG, 50 MG IH

PA 03 59520 Candesartan Methyl Ester IH 25 MG, 50 MG IH

PA 03 59530 Candesartan Ethyl Ester IH 25 MG, 50 MG IH

PA 03 59540 Candesartan Desethyl Impurity IH 25 MG, 50 MG IH

PA 03 59550 Candesartan Cilexetil Desethyl Impurity IH 25 MG, 50 MG IH

PA 03 59560 Candesartan Cilexetil HCl Methoxy Analog IH 25 MG, 50 MG IH

PA 03 59570 Candesartan N1-Trityl Impurity IH 25 MG, 50 MG IH

PA 03 59580 Candesartan Cilexetil N1-Trityl Impurity IH 25 MG, 50 MG IH

PA 03 59590 Candesartan N1-Trityl Ethyl Ester IH 25 MG, 50 MG IH

PA 03 59600 Candesartan Cilexetil N1-Ethyl Impurity IH 25 MG, 50 MG IH

PA 03 59610 Candesartan Cilexetil N2-Ethyl Impurity IH 25 MG, 50 MG IH

PA 03 59620 Candesartan Cilexetil N1-Ethyl Amide IH 25 MG, 50 MG IH

PA 03 59630 Candesartan Cilexetil N2-Ethyl Amide IH 25 MG, 50 MG IH

PA 03 59640 Candesartan Bromo Impurity IH 25 MG, 50 MG IH

PA 03 59650 Candesartan Hydroxy Impurity IH 25 MG, 50 MG IH

PA 03 59660 Candesartan Methyl Impurity IH 25 MG, 50 MG IHy p y 25 MG, 50 MG

PA 03 59670 Candesartan Trityl Alcohol Impurity IH 25 MG, 50 MG IH

PA 03 59680 Candesartan Trityl Methyl Ether Impurity IH 25 MG, 50 MG IH

PA 03 60000 Carvedilol API 25 MG, 50 MG EP

PA 03 60510 Carvedilol R-Isomer IH 25 MG, 50 MG IHPA 03 60510 Carvedilol R Isomer IH 25 MG, 50 MG IH

PA 03 60520 Carvedilol S-Isomer IH 25 MG, 50 MG IH

PA 03 60010 1-[[9-[2-hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]-9H-carbazol-4-yl]oxy]-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol ;


PA 03 60020 1,1'-[[2-(2-methoxyphenoxy)ethyl]nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol] ;


PA 03 60030 2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy)propan-2-ol ;


PA 03 60040 4-(2,3-Epoxypropoxy)carbazole ; Carvedilol Epoxide I it

Imp D 25 MG, 50 MG USPImpurity

PA 03 60050 2-(2-Methoxyphenoxy)ethylamine Hydrochloride ; Carvedilol Amine Impurity


PA 03 61000 Cefaclor API 25 MG, 50 MG EP

PA 03 61010 (2R)-2-amino-2-phenylacetic acid ("phenylglycine") Imp A 25 MG, 50 MG EP

PA 03 61020 6R,7R)-7-amino-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid


PA 03 61030 6R,7R)-7-[[(2S)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid ("Cefaclor 2S-Isomer")


PA 03 62000 Cefepime Hydrochloride API 25 MG 50 MG EPPA 03 62000 Cefepime Hydrochloride API 25 MG, 50 MG EP

PA 03 63000 Cefixime Trihydrate API 25 MG, 50 MG EP

PA 03 64000 Cefmetazole API 25 MG, 50 MG EP

PA 03 64510 Cefmetazole Sodium IH 25 MG, 50 MG IH

PA 03 65000 Cefotaxime (Acid) API 25 MG, 50 MG EP

PA 03 65510 Cefotaxime Sodium IH 25 MG, 50 MG IH

PA 03 66000 Cefoxitin (Acid) API 25 MG, 50 MG EP

PA 03 66510 Cefoxitin Sodium IH 25 MG, 50 MG IH

PA 03 67000 Cefsulodin (Acid) API 25 MG, 50 MG EP( ) ,

PA 03 67510 Cefsulodin Sodium IH 25 MG, 50 MG EP

PA 03 68000 Ceftiofur (Acid) API 25 MG, 50 MG EP

PA 03 68510 Ceftiofur Sodium IH 25 MG, 50 MG IH

PA 03 68520 Ceftiofur Hydrochloride IH 25 MG, 50 MG IH

PA 03 69000 cefuroxime (Acid) API 25 MG, 50 MG EP

PA 03 69510 Cefuroxime Sodium IH 25 MG, 50 MG IH

PA 03 69520 Cefuroxime Axetil IH 25 MG, 50 MG IH

PA 03 70000 Clavulanate Potassium API 25 MG, 50 MG

PA 03 71000 Cyamemazine API 25 MG, 50 MG EP

PA 03 71510 Cyamemazine Maleate IH 25 MG, 50 MG IH

PA 03 71520 Cyamemazine Tartrate IH 25 MG, 50 MG IH

PA 03 71530 2-Cyanophenothiazine IH 25 MG, 50 MG IH

PA 03 71540 2-Chlorophenothiazine IH 25 MG, 50 MG IH

PA 04 01000 Dexchlorpheniramine Maleate API 25 MG, 50 MG EP

PA 04 01010 (3RS) N N Dimethyl 3 phenyl 3 (pyridin 2 yl)propan 1 IMP A 25 MG 50 MG EPPA 04 01010 (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)propan-1-amine Maleate(Pheniramine Maleate)

IMP A 25 MG, 50 MG EP

.PA 04 02000 Dextromethorphan Hydrobromide Monohydrate API 25 MG, 50 MG EP

PA 04 02010 ent-3-Methoxymorphinan Hydrochloride Imp A 25 MG, 50 MG EP

PA 04 02510 Dextromethorphan N-Oxide Hydrochloride IH 25 MG, 50 MG IHp y ,

PA 04 03000 Dextropropoxyphene Hydrochloride API 25 MG, 50 MG EP

PA 04 04000 Dextropropoxyphene API 25 MG, 50 MG EP

PA 04 04010 (2S,3R)-4-(Dimethylamino)-1,2-diphenyl-3-methylbutan-2-ol (Oxyphene)

IMP A 25 MG, 50 MG EP(Oxyphene)

PA 04 04020 (1S,2R)-1-Benzyl-3-(dimethylamino)-2-methyl-1-phenylpropyl Acetate Hydrochloride(Acetoxyphene Hydrochloride)

IMP B 25 MG, 50 MG EP

PA 04 04050 Toluene IMP E 25 MG, 50 MG EP

PA 04 05000 Diazepam API 25 MG, 50 MG EP,

PA 04 05010 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one(Nordazepam)


PA 04 06000 2,4-Dichlorobenzyl Alcohol API 25 MG, 50 MG EP

PA 04 06510 Bis-(2,4-dichlorobenzyl) Ether IH 25 MG, 50 MG IH

PA 04 07000 Diclofenac Sodium API 25 MG, 50 MG EP

PA 04 07010 1-(2,6-Dichlorophenyl)-1,3- dihydro-2H-indol-2-one IMP A 25 MG, 50 MG EP

PA 04 07020 2-[(2,6-Dichlorophenyl)amino]-benzaldehyde IMP B 25 MG, 50 MG EP[( , p y ) ] y 25 MG, 50 MG

PA 04 07030 [2-[(2,6-Dichlorophenyl)-amino]phenyl]methanol IMP C 25 MG, 50 MG EP

PA 04 07050 1,3-Dihydro-2H-indol-2-one IMP E 25 MG, 50 MG EP

PA 04 07510 Methyl 2-[2-[(2,6-Dichlorophenyl)amino]- IH 25 MG, 50 MG IHPA 04 07510 Methyl 2 [2 [(2,6 Dichlorophenyl)amino]phenyl]acetate(Methyl Ester of Diclofenac)

IH 25 MG, 50 MG IH

PA 04 07520 Ethyl 2-[2-[(2,6-Dichlorophenyl)amino]-phenyl]acetate (Ethyl Ester of Diclofenac)

IH 25 MG, 50 MG IH

PA 04 07530 Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]-phenyl]acetate(Isopropyl Ester of Diclofenac)

IH 25 MG, 50 MG IH

PA 04 07540 2-(2,6-Dichlorophenylamino)benzoic Acid IH 25 MG, 50 MG IH

PA 04 07550 2,6-Dichlorodiphenylamine IH 25 MG, 50 MG IH

PA 04 07560 Diclofenac Potsium IH 25 MG, 50 MG IH

PA 04 07570 2,6-Dichloroaniline IH 25 MG, 50 MG IH

PA 04 08000 Dicloxacillin Sodium API 25 MG, 50 MG EP

PA 04 08030 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid(6-Aminopenicillanic Acid)


p )

PA 04 08010 Penicilloic acid of dicloxacillin N-Acetylated dicloxcilloic acid Imp A 25 MG, 50 MG EP

PA 04 09000 Digitoxigenin API 25 MG, 50 MG EP

PA 04 10000 Digoxin API 25 MG, 50 MG EP

PA 04 11000 Diltiazem Hydrochloride API 25 MG, 50 MG EPPA 04 11000 Diltiazem Hydrochloride API 25 MG, 50 MG EP

PA 04 11040 (2S,3S)-2-(4-Methoxyphenyl)-5-[2-(methylamino)ethyl]-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate Hydrochloride (N-Desmethyl-diltiazem Hydrochloride)


PA 04 11510 Diltiazem Sulphoxide IH 25 MG, 50 MG IH

PA 04 11520 O-Desacetyl Diltiazem Hydrochloride IH 25 MG, 50 MG IH

PA 04 11530 N-Desmethyl Diltiazem Hydrochloride IH 25 MG, 50 MG IH

PA 04 11540 N,N-DiDesmethyl Diltiazem Hydrochloride IH 25 MG, 50 MG IH

PA 04 11550 Diltiazem Maleate IH 25 MG, 50 MG IH

PA 04 12000 Dimenhydrinate API 25 MG, 50 MG EP

PA 04 12010 Theophylline IMP A 25 MG, 50 MG EP

PA 04 12030 Caffeine IMP C 25 MG 50 MG EPPA 04 12030 Caffeine IMP C 25 MG, 50 MG EP

PA 04 12060 2-(Diphenyl-methoxy)-N-methylethanamine Hydrochloride (Diphenhydramine Imp. A Hydrochloride; Nordiphenhydramine Hydrochloride)

IMP F 25 MG, 50 MG EP

PA 04 12070 N,N-Dimethyl-2-[(RS)-(4-methylphenyl)(phenyl)methoxy]-ethanamine Hydrochloride (4-Methyldiphen-hydramine

IMP G 25 MG, 50 MG EPethanamine Hydrochloride (4-Methyldiphen-hydramine Hydrochloride)

PA 04 12080 2-[(RS)-(4- Bromophenyl)(phenyl)methoxy]-N,N-dimethylethanamine Hydrochloride (4-Bromodiphen- hydramine Hydrochloride; Bromazine Hydro- chloride)

IMP H 25 MG, 50 MG EP

PA 04 12090 Diphenylmethanol (Benzhydrol) IMP I 25 MG, 50 MG EP

PA 04 12100 Diphenylmethanone (Benzophenone) IMP J 25 MG, 50 MG EP

PA 04 12110 [Oxybis(methanetriyl)]tetrabenzene (Bis(diphenylmethyl) Ether)

IMP K 25 MG, 50 MG EP

PA 04 12510 Diphenhydramine Hydrochloride IH 25 MG, 50 MG IH

PA 04 12520 8-Chlorotheophylline IH 25 MG, 50 MG IH

PA 04 13000 Dimetindene Maleate API 25 MG, 50 MG EP

PA 04 13010 2-Ethylpyridine IMP A 25 MG, 50 MG EPy py 25 MG, 50 MG

PA 04 14000 Diphemanil Metilsulfate API 25 MG, 50 MG EP

PA 04 15000 Diphenhydramine Hydrochloride API 25 MG, 50 MG EP

PA 04 15010 2-(Diphenyl-methoxy)-N-methylethanamine IMP A 25 MG, 50 MG EPHydrochloride(Nordiphenhydramine Hydrochloride)

,

PA 04 15020 2-[(RS)-(4-Methylphenyl)phenylmethoxy]-N,N-dimethylethanamine Hydrochloride(4-Methyldiphenhydramine Hydrochloride)


PA 04 15030 2-[(RS)- (4-Bromophenyl)phenylmethoxy]-N,N- dimethylethanamine Hydrochloride (Bromazine

IMP C 25 MG, 50 MG EPy y (

Hydrochloride)

PA 04 15040 Diphenylmethanol (Benzhydrol) IMP D 25 MG, 50 MG EP

PA 04 15050 Diphenylmethanone IMP E 25 MG, 50 MG EP

PA 04 15510 Diphenhydramine N-Oxide IH 25 MG, 50 MG IH

PA 04 16000 Diphenylpyraline Hydrochloride API 25 MG, 50 MG EP

PA 04 16510 Diphenylpyraline IH 25 MG, 50 MG IH

PA 04 16520 Diphenylmethanol (Benzhydrol) IH 25 MG, 50 MG IH

PA 04 16530 Diphenylmethanone (Benzophenone) IH 25 MG, 50 MG IH

PA 04 16540 Diphenylpyraline N-Oxide IH 25 MG, 50 MG IH

PA 04 16550 N-Desmethyldiphenylpyraline Hydrochloride (4-(Diphenylmethoxy)piperidine Hydrochloride)

IH 25 MG, 50 MG IH

PA 04 17000 Dipotsium Clorazepate API 25 MG, 50 MG EP

PA 04 17010 (2-Amino-5-chlorophenyl)phenyl-methanone (Aminochlorobenzophenone)


PA 04 17020 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one (Nordazepam)

IMP B 25 MG, 50 MG EP( p )

PA 04 18000 Diprafenon Hydrochloride API 25 MG, 50 MG EP

PA 04 18510 2'-Hydroxy-3-phenylpropiophenone IH 25 MG, 50 MG IH

PA 04 19000 Disopyramide API 25 MG, 50 MG EP

PA 04 19010 (2RS)-4-[bis(1-methylethyl)amino]-2-phenyl-2-(pyridin-2- Imp A 25 MG, 50 MG EPPA 04 19010 (2RS) 4 [bis(1 methylethyl)amino] 2 phenyl 2 (pyridin 2yl)butanenitrile (Diisopyronitrile)


PA 04 19030 (2RS)-4-[(1-Methylethyl)amino]-2-phenyl-2-(pyridin-2-yl)-butanamide


PA 04 20000 Dithranol API 25 MG, 50 MG EP

PA 04 20010 Anthracen-9(10H)-one (Anthrone) IMP A 25 MG, 50 MG EPPA 04 20010 Anthracen 9(10H) one (Anthrone) IMP A 25 MG, 50 MG EP

PA 04 21000 Dobutamine Hydrochloride API 25 MG, 50 MG EP

PA 04 21010 Dopamine Hydrochloride IMP A 25 MG, 50 MG EP

PA 04 21020 4-(4-Hydroxyphenyl)butan-2-one IMP B 25 MG, 50 MG EP

PA 04 22000 Dodecylguanidinium Acetate API 25 MG, 50 MG EP

PA 04 22510 Dimethyldodecylamine IH 25 MG, 50 MG IH

PA 04 23000 Domperidone API 25 MG, 50 MG EP

PA 04 23010 5 Chloro 1 (piperidin 4 yl) 1 3 dihydro 2H benzimidazol 2 IMP A 25 MG 50 MG EPPA 04 23010 5-Chloro-1-(piperidin-4-yl)-1,3-dihydro-2H-benzimidazol-2-one


PA 04 23020 4-(5-Chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-formylpiperidine


PA 04 23060 1,3-Bis[3-[4-(5-chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)piperidin-1-yl]propyl]-1,3-dihydro-2H-benzimidazol-2-one


PA 04 23510 1,3-Dihydro-2H-benzimidazol-2-one IH 25 MG, 50 MG IH

PA 04 24000 Doxorubicin Hydrochloride API 25 MG, 50 MG EP

PA 04 24040 Doxorubicin aglycone Imp D 25 MG, 50 MG EP

PA 04 25000 Donepezil Hydrochloride API 25 MG, 50 MG EP

PA 04 26000 Doxylamine Succinate API 25 MG, 50 MG EP

PA 04 26010 N,N-Dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]-ethanamine


PA 04 26020 (1RS)-1-Phenyl-1-(pyridin-2-yl)ethanol Imp B 25 MG, 50 MG EP

PA 04 26030 N,N-Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)-methoxy]ethanamine


PA 04 27000 Donepezil API 25 MG, 50 MG EP

PA 04 28000 Dopamine Hydrochloride API 25 MG 50 MG EPPA 04 28000 Dopamine Hydrochloride API 25 MG, 50 MG EP

PA 04 28010 5-(2-Amino-ethyl)-2-methoxyphenol Hydrochloride (4-O-Methyldopamine Hydrochloride)


PA 04 28030 2-(3,4-Dimethoxyphenyl)-ethanamine IMP C 25 MG, 50 MG EP

PA 04 29000 Dosulepin Hydrochloride API 25 MG, 50 MG EP

PA 04 29020 Dibenzo[b,e]thiepin-11(6H)-one IMP B 25 MG, 50 MG EP

PA 04 30000 Doxazosin Mesilate API 25 MG, 50 MG EP

PA 04 31000 Doxazosin API 25 MG 50 MG EPPA 04 31000 Doxazosin API 25 MG, 50 MG EP

PA 04 31010 (2RS)-2,3-Dihydro-1,4-benzodioxine-2-carboxylic Acid IMP A 25 MG, 50 MG EP

PA 04 31020 1-[(2RS)-2,3- Dihydro-1,4-benzodioxin-2-ylcarbonyl]piperazine Hydrochloride


PA 04 31030 1,4-Bis(2,3-dihydro-1,4-benzodioxin- 2-ylcarbonyl)piperazine


PA 04 31060 2-Chloro-6,7-dimethoxyquinazolin- 4-amine IMP F 25 MG, 50 MG EP

PA 04 31070 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin-4-amine IMP G 25 MG, 50 MG EP

PA 04 31080 2 2'-(Piperazine-1 4-diyl)bis(6 7-dimethoxyquinazolin-4- IMP H 25 MG 50 MG EPPA 04 31080 2,2 -(Piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine)


PA 04 32000 Doxepin Hydrochloride API 25 MG, 50 MG EP

PA 04 33000 Doxylamine Hydrogen Succinate API 25 MG, 50 MG EP

PA 04 33040 Phenyl(pyridin-2-yl)methanone(2-Benzoylpyridine) Imp. D 25 MG, 50 MG EP,

PA 04 33510 Doxylamine N-Oxide Dihydrochloride IH 25 MG, 50 MG I

PA 04 34000 Drofenine Hydrochloride API 25 MG, 50 MG EP

PA 04 34510 Drofenine N-Oxide Hydrochloride IH 25 MG, 50 MG IH,

PA 04 35000 Desloratadine API 25 MG, 50 MG IH

PA 04 35510 N-Hydroxy Desloratadine IH 25 MG, 50 MG IH

PA 04 35520 3-Hydroxy Desloratadine IH 25 MG, 50 MG IH

PA 04 35530 N-Formyl Desloratadine IH 25 MG, 50 MG IHPA 04 35530 N Formyl Desloratadine IH 25 MG, 50 MG IH

PA 04 35540 N-Methyl Desloratadine IH 25 MG, 50 MG IH

PA 04 35550 N-Acetyl Desloratadine IH 25 MG, 50 MG IH

PA 04 35560 Desloratadine Isomer IH 25 MG, 50 MG IH

PA 04 36000 Dexpanthenol API 25 MG, 50 MG EP

PA 04 36510 Dexpanthenol Racemate IH 25 MG, 50 MG IH

PA 04 36520 Dexpanthenol Lactone Impurity IH 25 MG, 50 MG IH

PA 04 37000 Di i Di h i Di t l h i API 25 MG 50 MG EPPA 04 37000 Diacerein; Diacerhein; Diacetylrhein API 25 MG, 50 MG EP

PA 04 37510 Rhein IH 25 MG, 50 MG IH

PA 04 37520 Monoacerein IH 25 MG, 50 MG IH

PA 04 37530 Aloe Emodin IH 25 MG, 50 MG IH

PA 04 38000 Dipyridamole API 25 MG, 50 MG EP

PA 04 38010 2,2'-[[4,6,8-tri(piperidin-1-yl)-pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol


PA 04 38020 2,2',2",2''',2'''',2'''''-[[8-(Piperidin-1-yl)-pyrimido[5,4-d]pyrimidine 2 4 6 triyl]trinitrilo]hexaethanol

Imp B 25 MG, 50 MG EPd]pyrimidine-2,4,6-triyl]trinitrilo]hexaethanol

PA 04 38030 2,2'-[[2-chloro-4,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidin-6-yl]nitrilo]diethanol


PA 04 38040 2,2'-[[2-(2-Hydroxyethyl)amino-4,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidin-6-yl]nitrilo]diethanol


PA 04 38050 2,4-Di[di(2-hydroxyethyl)amino]-6,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine


PA 04 38060 4,6-Di[di(2-hydroxyethyl)amino]-2-(2-hydroxyethyl)amino-8-(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine


PA 04 38070 2,6-Dichloro-4,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine Imp G 25 MG, 50 MG EP, , (p p y ) py [ , ]py p 25 MG, 50 MG

PA 04 38510 Dipyridamole Tetrachloro Impurity

2,4,6,8-Tetrachloro-pyrimido[5,4-d]pyrimidine

IH 25 MG, 50 MG IH

PA 04 38520 Dipyridamole Trichloro Impurity

2,4,6-Trichloro-8-(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine

IH 25 MG, 50 MG IH

PA 04 38530 Dipyridamole Dichloro Impurity

2,6-Dichloro-4-di(2-hydroxyethyl)amino-8-(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine

IH 25 MG, 50 MG IH

PA 04 39000 Duloxetine Hydrochloride API 25 MG, 50 MG EP

PA 04 39510 N-Methyl Duloxetine CAS Name: (S)-(+)-N,N-Dimethyl-3-(1-naphthoxy)-3-(2-thienyl)-1-propylamine

IH 25 MG, 50 MG IH

PA 04 39520 N-Desmethyl Duloxetine (S)-(+)-3-(1-naphthoxy)-3-(2-thienyl)-1-propylamine

IH 25 MG, 50 MG IH

PA 04 39530 (S)-(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl) propanamine IH 25 MG, 50 MG IH

PA 05 01000 Ebastine API 25 MG, 50 MG EP

PA 05 01010 Diphenylmethanol (Benzhydrol) IMP A 25 MG, 50 MG EP

PA 05 01030 4-(Diphenyl- methoxy)piperidine Hydrochloride IMP C 25 MG, 50 MG EP

PA 05 01040 1-[4-(1,1-Dimethylethyl)phenyl]- 4-(4-hydroxypiperidin-1-yl)butan-1-one


PA 05 01050 1-[4-(1,1- Dimethylpropyl)phenyl]-4-[4-(diphenylmethoxy)- piperidin-1-yl]butan-1-one Hydrogen Fumarate

IMP E 25 MG, 50 MG EP

PA 05 02000 Enalapril Maleate API 25 MG, 50 MG EP

PA 05 02010 N-[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline (" Enalapril R-Isomer ")

Imp A 25 MG, 50 MG

PA 05 02020 (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- 3-phenylpropyl]amino]propanoic Acid


PA 05 02030 (2S)-1-[(2S)-2-[[(1S)-1-Carboxy- 3-phenylpropyl]amino]propanoyl]pyrrolidine-2- carboxylic Acid (Enalaprilat)


PA 05 02040 Ethyl (2S)-2-[(3S,8)-3-Methyl- 1,4-dioxo-octahydropyrrolo[1,2-a]pyrazin-2-yl]- 4-phenylbutanoate (Enalapril Diketopiperazine)


PA 05 02050 (2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2-phenylethoxy) carbonyl]propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid ("Enalapril Phenylethoxy Analog")

Imp E 25 MG, 50 MG

("Enalapril Phenylethoxy Analog")

PA 05 02060 (2S)-1-[(2S)-2-[[(1S)-1-(Butoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid ("Enalapril Butoxy Analog")

Imp F 25 MG, 50 MG

PA 05 02070 (2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino] propanoic acid

Imp G 25 MG, 50 MGpropanoic acid ("Enalapril Cyclohexyl ECPPA Analog")

PA 05 02080 2S)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl] amino]propanoyl]pyrrolidine-2-carboxylic acid ("Enalapril Cyclohexyl Analog")

Imp H 25 MG, 50 MG

PA 05 02090 1H-Imidazole (Imidazole) IMP I 25 MG, 50 MG EP( ) ,

PA 05 02510 (2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3- phenylpropyl]amino]propanoic Acid Ethyl Ester Hydrochloride

IH 25 MG, 50 MG IH

PA 05 02520 Enalapril Impurity : S,R-ECPPA IH 25 MG, 50 MG IH

PA 05 02530 Enalapril Impurity : R,R-ECPPA IH 25 MG, 50 MG IH

PA 05 02540 Enalapril Impurity : R,S-ECPPA IH 25 MG, 50 MG IH

PA 05 03000 Enrofloxacin API 25 MG, 50 MG EP

PA 05 03020 1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride Monohydrate(Ciprofloxacin Hydrochloride Monohydrate)


PA 05 03030 1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride (Desfluoroenrofloxacin Hydrochloride)


PA 05 03070 7-[(2-Aminoethyl)amino]-1-cyclopropyl- 6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid


PA 05 03510 Enrofloxacin N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 05 04000 Entacapon API 25 MG, 50 MG EP

PA 05 04030 3,4-Dihydroxy-5-nitrobenzaldehyde IMP C 25 MG, 50 MG EP

PA 05 05000 Ephedrine Hydrochloride API 25 MG, 50 MG EP

PA 05 05020 Pseudoephedrine Hydrochloride IMP B 25 MG, 50 MG EP

PA 05 06000 Erdosteine API 25 MG 50 MG EPPA 05 06000 Erdosteine API 25 MG, 50 MG EP

PA 05 07000 Erythromycin API 25 MG, 50 MG EP

PA 05 07020 N-Demethylerythromycin A IMP B 25 MG, 50 MG EP

PA 05 08000 Esomeprazole magnesium trihydrate API 25 MG, 50 MG EP

PA 05 08010 5-Methoxy-1H-benzimidazole-2-thiol IMP A 25 MG, 50 MG EP

PA 05 08020 2-[(RS)-[(3,5-Dimethylpyridin-2-yl)methyl]sulphinyl]-5-methoxy-1H-benz-imidazole


PA 05 08030 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]-sulphanyl]-1H-benzimidazole (Ufiprazole)

IMP C 25 MG, 50 MG EPp y ] ( p )

PA 05 08040 5-Methoxy-2-[[(4-methoxy-3,5- dimethylpyridin-2-yl)methyl]sulphonyl]-1H- benzimidazole (Omeprazole Sulphone)


PA 05 08050 4-Methoxy-2-[[(RS)-(5-methoxy- 1H-benzimidazol-2-yl)sulphinyl]methyl]-3,5- dimethylpyridine 1-Oxide (Omepra ole N O ide)


(Omeprazole N-Oxide)

PA 05 08510 Esomeprazole Potassium IH 25 MG, 50 MG IH

PA 05 08520 Esomeprazole Sodium IH 25 MG, 50 MG IH

PA 05 08010 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2- Imp A 25 MG, 50 MG USPy [[( y y pyyl)methyl]sulfonyl]-1H-benzimidazole (= OMP05: Omeprazole EP Impurity D; Omeprazole Sulfone)

p ,

PA 05 08530 Esomeprazole R-Isomer (Sodium); (R)-Omeprazole (Sodium) (= OMP21NA)

5-Methoxy-2-((R)-((4-methoxy-3,5-dimethyl-2- idi l) th l) lfi l) 1H b i id l di lt

IH 25 MG, 50 MG IH

pyridinyl)methyl)sulfinyl)-1H-benzimidazole sodium salt

PA 05 09000 Estradiol Enanthate API 25 MG, 50 MG EP

PA 05 10000 Estradiol Hemihydrate API 25 MG, 50 MG EP

PA 05 11000 Estradiol Valerate API 25 MG, 50 MG EP

PA 05 11010 Hemihydrate:Estradiol Hemihydrate IMP A 25 MG, 50 MG EP

PA 05 12000 Estrone API 25 MG, 50 MG EP

PA 05 12510 Estrone 3-Methyl Ether IH 25 MG, 50 MG IH

PA 05 13000 Ethosuximide API 25 MG, 50 MG EP,

PA 05 14000 Ethyl Parahydroxybenzoate API 25 MG, 50 MG EP

PA 05 15000 Etilefrine hydrochloride API 25 MG, 50 MG EP

PA 05 15020 (1RS)-1-(3-Hydroxyphenyl)-2-( th l i ) th lH d hl id (Ph l h i

IMP B 25 MG, 50 MG EP(methylamino)ethanolHydrochloride (Phenylephrine Hydrochloride)

PA 05 15030 (1RS)-2-Amino-1-(3-hydroxyphenyl)ethanol Hydrochloride(Norfenefrine Hydrochloride)


PA 05 15050 1-(3-Hydroxyphenyl)ethanone(3-Hydroxyacetophenone) IMP E 25 MG, 50 MG EP

PA 05 15060 N-Benzylethanamine(Benzylethylamine) IMP F 25 MG, 50 MG EP

PA 05 15510 3-Benzoyloxyacetophenone IH 25 MG, 50 MG IH

PA 05 16000 Etodolac API 25 MG, 50 MG EP

PA 05 16010 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Desethyl Etodolac)


PA 05 16020 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Methyl Etodolac)


PA 05 16030 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Methyl Etodolac)


PA 05 16040 2-[(1RS)-1-ethyl-8-(1-methylethyl)-1,3,4,9-tetrahydropyrano[3,4-b]-indol-1-yl]acetic acid (8-Isopropyl etodolac)


PA 05 16060 2-[(1RS)-8-Ethyl-1-(1-methylethyl)- 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Isopropyl Etodolac)


PA 05 16080 2-(7-Ethylindol-3-yl)ethanol IMP H 25 MG, 50 MG EP

PA 05 16100 (1RS)-1,8-Diethyl-1-methyl-1,3,4,9- tetrahydropyrano[3,4-b]i d l (D b Et d l )

IMP J 25 MG, 50 MG EPb]indole (Decarboxy Etodolac)

PA 05 16110 2-[(1RS)-1,8-Diethyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetate (Etodolac Methyl Ester)


PA 05 17000 Etofenamate API 25 MG, 50 MG EP

PA 05 17010 2-[[3-(Trifluoromethyl)phenyl]- amino]benzoic Acid IMP A 25 MG 50 MG EPPA 05 17010 2-[[3-(Trifluoromethyl)phenyl]- amino]benzoic Acid (Flufenamic Acid)


PA 05 17020 Butyl 2-[[3-(Trifluoromethyl)phenyl]- amino]benzoate (Butyl Flufenamate)


PA 05 17030 N-Phenyl-3-(trifluoromethyl)aniline IMP C 25 MG, 50 MG EP

PA 05 17040 2,2'-Oxybis(ethylene) Bis[2-[[3- (trifluoromethyl)phenyl]amino]benzoate]


PA 05 17050 2-(2-Butoxyethoxy)ethyl 2-[[3- (Trifluoromethyl)phenyl]amino]benzoate


PA 05 17060 2,2'-Oxydiethanol IMP F 25 MG, 50 MG EP, y 25 MG, 50 MG

PA 05 17070 2-Hydroxyethyl 2-[[3-(Trifluoro- methyl)phenyl]amino]benzoate


PA 05 18000 Etofylline API 25 MG, 50 MG EP

PA 05 19000 Enalapril API 25 MG, 50 MG

PA 05 20000 Erlotinib API 25 MG, 50 MG EP

PA 05 20510 Erlotinib Desmethyl Metabolite ("Major Metabolite-M14" ; "OSI-420")

IH 25 MG, 50 MG IH

PA 05 20520 Erlotinib Desmethyl Metabolite Isomer ("Minor Metabolite-M13")

IH 25 MG, 50 MG IHM13 )

PA 05 20530 Erlotinib Didesmethyl Metabolite ("Minor Metabolite-M12") [CAS # 183320-12-9]

IH 25 MG, 50 MG IH

PA 05 20540 Erlotinib Carboxylic Acid ("Minor Metabolite-M6") IH 25 MG, 50 MG IH

PA 05 20550 Erlotinib Hydroxy Metabolite ("Minor Metabolite-M16") IH 25 MG, 50 MG IH

PA 05 20560 Erlotinib Lactam Impurity

6,7-bis-(2-Methoxyethoxy)-quinazolin-4(3H)-one

IH 25 MG, 50 MG IH

PA 05 21000 Esomeprazole API 25 MG, 50 MG EP

PA 06 01000 Famotidine API 25 MG, 50 MG EP

PA 06 01010 3-[[[2-(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanimidamide


PA 06 01020 3 5 Bi [2 [[[2 [(di i th l ) i ] I B EPPA 06 01020 3,5-Bis[2-[[[2-[(diaminomethylene)amino]-thiazol-4-yl]methyl]sulphanyl]ethyl]-4H-1,2,4,6-thiatriazine 1,1-dioxide dimaleate


PA 06 01030 3-[[[2-(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]-N-sulphamoylpropanamide


PA 06 01040 3-[[[2-[(Diaminomethylene)- amino]thiazol-4- IMP D 25 MG, 50 MG EP[[[ [( y ) ]yl]methyl]sulphanyl]- propanamide

25 MG, 50 MG

PA 06 01060 3-[[[2-[(Diaminomethylene)- amino]thiazol-4-yl]methyl]sulphanyl]- propanoic Acid


PA 06 02000 Felodipine API 25 MG, 50 MG EP

PA 06 02010 Ethyl Methyl 4-(2,3- Dichlorophenyl)-2,6-dimethylpyridine-3,5- dicarboxylate


PA 06 02020 Dimethyl 4-(2,3- Dichlorophenyl)-2,6-dimethyl-1,4- dihydropyridine-3,5-dicarboxylate


PA 06 02030 Diethyl 4-(2,3- Dichlorophenyl)-2,6-dimethyl-1,4- IMP C 25 MG, 50 MG EPPA 06 02030 Diethyl 4 (2,3 Dichlorophenyl) 2,6 dimethyl 1,4 dihydropyridine-3,5-dicarboxylate


PA 06 03000 FENBENDAZOLE API 25 MG, 50 MG EP

PA 06 03010 Methyl (1H-Benzimidazol-2- yl)carbamate (Carbendazim) IMP A 25 MG, 50 MG EP

PA 06 03510 Fenbendazole Sulphoxide (Oxfendazole) IH 25 MG, 50 MG IH

PA 06 03520 Fenbendazole Sulphone IH 25 MG, 50 MG IH

PA 06 04000 Fenbufen API 25 MG, 50 MG EP

PA 06 04030 Biphenyl IMP C 25 MG 50 MG EPPA 06 04030 Biphenyl IMP C 25 MG, 50 MG EP

PA 06 05000 Fenfluramine Hydrochloride API 25 MG, 50 MG EP

PA 06 06000 Fenofibrate API 25 MG, 50 MG EP

PA 06 06010 (4-Chlorophenyl)(4- hydroxyphenyl)methanone IMP A 25 MG, 50 MG EP

PA 06 06020 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic Acid (Fenofibric Acid)


PA 06 06030 (3RS)-3-[4-(4-chlorobenzoyl)-phenoxy]butan-2-one IMP C 25 MG, 50 MG EP

PA 06 06040 Methyl2-[4-(4-Chlorobenzoyl)-phenoxy]-2-methylpropanoate IMP D 25 MG, 50 MG EP

PA 06 06050 Ethyl 2-[4-(4-Chlorobenzoyl)-phenoxy]-2-methylpropanoate IMP E 25 MG 50 MG EPPA 06 06050 Ethyl 2-[4-(4-Chlorobenzoyl)-phenoxy]-2-methylpropanoate IMP E 25 MG, 50 MG EP

PA 06 06060 (4-Chlorophenyl)[4-(1-methyl-ethoxy)phenyl]methanone IMP F 25 MG, 50 MG EP

PA 06 06070 1-Methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoyl]oxy]-2-methylpropanoate


PA 06 07000 Fentanyl API 25 MG, 50 MG EP

PA 06 07010 N-Phenyl-N- [cis,trans-1-oxido-1-(2-phenylethyl)piperidin- 4-yl]propanamide Hydrochloride (Fentanyl N-Oxide Hydrochloride)


PA 06 07020 N-Phenyl-N-(piperidin-4- yl)propanamide IMP B 25 MG, 50 MG EP

PA 06 07030 N-Phenyl-N-[1-(2-phenylethyl)- piperidin-4-yl]acetamide IMP C 25 MG, 50 MG EPy [ ( p y y ) p p y ] ,

PA 06 07040 N-Phenyl-1-(2-phenylethyl)piperidin- 4-amine IMP D 25 MG, 50 MG EP

PA 06 07060 Aniline Hydrochloride (Phenylamine Hydrochloride) IMP F 25 MG, 50 MG EP

PA 06 07070 N-Phenylpropanamide IMP G 25 MG, 50 MG EP

PA 06 08000 Fexofenadine hydrochloride API 25 MG, 50 MG EP

PA 06 08010 2-[4-[4-[4-(Hydroxydiphenyl- methyl)piperidin-1-yl]butanoyl]phenyl]-2- methylpropanoic Acid (Ketofexofenadine)


PA 06 08030 (1RS)-4-[4-(Hydroxydiphenyl- methyl)piperidin-1-yl]-1-[4-(1- IMP C 25 MG, 50 MG EP( ) [ ( y y p y y )p p y ] [ (methylethyl)- phenyl]butan-1-ol

25 MG, 50 MG

PA 06 08040 Methyl 2-[4-[(1RS)-1-Hydroxy-4-[4-(hydroxydiphenylmethylpiperidin-1-yl]butyl]-phenyl]-2-methylpropanoate


PA 06 08050 Diphenyl(piperidin-4-yl)methanol IMP E 25 MG, 50 MG EP

PA 06 09000 Finasteride API 25 MG, 50 MG EP

PA 06 09010 N-(1,1-Dimethylethyl)-3-oxo- 4-aza-5α-androstane-17β-carboxamide (Dihydrofinteride)


PA 06 09020 Methyl 3-Oxo-4-aza-5α-androst- 1-ene-17β-carboxylate (Δ-1- Imp B 25 MG 50 MG EPPA 06 09020 Methyl 3-Oxo-4-aza-5α-androst- 1-ene-17β-carboxylate (Δ-1-Aza Ester)


PA 06 10000 Fenoprofen Calcium Dihydrate API 25 MG, 50 MG EP

PA 06 11000 Flavoxate Hydrochloride API 25 MG, 50 MG EP

PA 06 11010 3 Methyl 4 oxo 2 phenyl 4H 1 benzopyran 8 carboxylic Acid IMP A 25 MG 50 MG EPPA 06 11010 3-Methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic Acid (3-Methyl-flavone-8-carboxylic Acid)


PA 06 11020 Ethyl 3-Methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate (3-Methyl-flavone-8-carboxylic Acid Ethyl Ester)


PA 06 11030 1-Methylethyl 3-Methyl-4-oxo- 2-phenyl-4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic Acid Isopropyl

IMP C 25 MG, 50 MG EPcarboxylate (3-Methylflavone-8-carboxylic Acid Isopropyl Ester)

PA 06 12000 Flubendazole API 25 MG, 50 MG EP

PA 06 12020 (2-Amino-1H-benzimidazol-5-yl)(4-fluorophenyl)methanone IMP B 25 MG, 50 MG EP

PA 06 12030 (4 Fl h l)(2 h d 1H b i id l 5 IMP C EPPA 06 12030 (4-Fluorophenyl)(2-hydroxy- 1H-benzimidazol-5-yl)methanone


PA 06 12040 (1H-Benzimidazol-5-yl)(4- fluorophenyl)methanone IMP D 25 MG, 50 MG EP

PA 06 13000 Flucloxacillin Sodium Hydrate API 25 MG, 50 MG EP

PA 06 13010 [3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4- Imp A 25 MG 50 MG EPPA 06 13010 [3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]-5,5-dimethylthiazolidine-4- carboxylic acid (penicilloic acids of flucloxacillin)


PA 06 13030 (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)


PA 06 13040 3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic Acid


PA 06 14000 Fluconazole API 25 MG, 50 MG EP

PA 06 14010 (2RS)-2-(2,4-Difluorophenyl)- 1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol- 4-yl)propan-2-ol


PA 06 14020 2-[2-Fluoro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol


PA 06 14030 1,1'-(1,3-Phenylene)di-1H-1,2,4- triazole IMP C 25 MG, 50 MG EP

PA 06 14040 2-(4-Fluorophenyl)-1,3-bis(1H- 1,2,4-triazol-1-yl)propan-2-ol IMP D 25 MG, 50 MG EP

PA 06 14510 4-Amino-1,2,4-triazole IH 25 MG, 50 MG IH

PA 06 14080 (2RS)-1-bromo-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol


PA 06 15000 Flucytosine API 25 MG, 50 MG EP

PA 06 15010 Fluorouracil IMP A 25 MG, 50 MG EP

PA 06 16000 Flufenamic Acid API 25 MG, 50 MG EP

PA 06 17000 Flunarizine Dihydrochloride API 25 MG, 50 MG EP

PA 06 17010 1-[Bis(4-fluorophenyl)methyl]-piperazine IMP A 25 MG, 50 MG EP

PA 06 17030 Di1 [(RS) (2 Fluorophenyl)(4 fluorophenyl)methyl] 4 [(2E) 3 IMP C 25 MG 50 MG EPPA 06 17030 Di1-[(RS)-(2-Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)-3-phenylprop-2-enyl]piperazineDihydrochloride


PA 06 17510 Chlorobis-(4-fluorophenyl)methane IH 25 MG, 50 MG IH

PA 06 17520 1-Bis(4-fluorophenyl)methyl-4-(ethoxycarbonyl)piperazine IH 25 MG, 50 MG IH

PA 06 17530 Flunarizine N-Oxide Dihydrochloride IH 25 MG, 50 MG IH

PA 06 18000 Flunitrazepam API 25 MG, 50 MG EP

PA 06 18020 5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one(Demethylflunitrazepam)


PA 06 19000 Flunixin Meglumine API 25 MG 50 MG EPPA 06 19000 Flunixin Meglumine API 25 MG, 50 MG EP

PA 06 19010 2-Chloropyridine-3-carboxylic Acid IMP A 25 MG, 50 MG EP

PA 06 19030 Ethyl 2-Chloropyridine-3-carboxylate IMP C 25 MG, 50 MG EP

PA 06 20000 Fluorouracil API 25 MG, 50 MG EP

PA 06 20010 Pyrimidine-2,4,6-(1H,3H,5H)-trione (Barbituric Acid) IMP A 25 MG, 50 MG EP

PA 06 20020 Dihydropyrimidine-2,4,5(3H)- trione (Isobarbituric Acid or 5-Hydroxyuracil)


PA 06 20030 Pyrimidine-2,4(1H,3H)-dione (Uracil) IMP C 25 MG, 50 MG EP

PA 06 20050 5-Chloropyrimidine-2,4(1H,3H)- dione (5-Chlorouracil) IMP E 25 MG, 50 MG EP

PA 06 21000 Fluoxetine Hydrochloride API 25 MG, 50 MG EP

PA 06 21010 (1RS)-3-(Methylamino)-1- phenylpropan-1-ol IMP A 25 MG, 50 MG EP

PA 06 21510 4-Hydroxybenzotrifluoride IH 25 MG, 50 MG IHPA 06 21510 4 Hydroxybenzotrifluoride IH 25 MG, 50 MG IH

PA 06 22000 Fluoxymesterone API 25 MG, 50 MG EP

PA 06 23000 Flupentixol Decanoate API 25 MG, 50 MG EP

PA 06 23020 2-Trifluoromethyl thioxanthone Imp. B 25 MG, 50 MG EP

PA 06 23510 1-(2-Hydroxyethyl)piperazine IH 25 MG, 50 MG IH

PA 06 23520 4-Chloro-3-nitrobenzotrifluoride IH 25 MG, 50 MG IH

PA 06 23530 4-Fluoro-3-nitrobenzotrifluoride IH 25 MG, 50 MG IH

PA 06 24000 Flupentixol Dihydrochloride API 25 MG, 50 MG EP

PA 06 24070 2-(Trifluoromethyl)-9H-thioxanthen-9-one (2-Trifluoromethyl-thioxanthone)


PA 06 24510 1-(2-Hydroxyethyl)piperazine IH 25 MG, 50 MG IH

PA 06 24520 4-Chloro-3-nitrobenzotrifluoride IH 25 MG, 50 MG IH

PA 06 25000 Fluphenazine Dihydrochloride API 25 MG, 50 MG EP

PA 06 25010 2-[4-[3-[5-Oxo-2-(trifluoromethyl)- 10H-54-phenothiazin-10-yl]propyl]piperazin-1- yl]ethanol (Fluphenazine S-Oxide)


PA 06 25020 2-[4-[3-[5,5-dioxo-2-(trifluoromethyl)-10H-56-phenothiazin- Imp B 25 MG, 50 MG EP[ [ [ , ( y ) p10-yl]propyl]piperazin-1-yl]ethanol (Fluphenazine S,S-dioxide)

p 25 MG, 50 MG

PA 06 26000 Flurazepam API 25 MG, 50 MG EP

PA 06 26020 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one

IMP B 25 MG, 50 MG EPbenzodiazepin 2 one

PA 06 27000 Flurbiprofen API 25 MG, 50 MG EP

PA 06 27010 (2RS)-2-(Biphenyl-4-yl)propanoic Acid IMP A 25 MG, 50 MG EP

PA 06 27030 (2RS)-2-(2-fluorobiphenyl-4-yl)-2-hydroxypropanoic acid Imp C 25 MG, 50 MG EP

PA 06 27040 1-(2-Fluorobiphenyl-4-yl)ethanone IMP D 25 MG, 50 MG EP

PA 06 27050 2-Fluorobiphenyl-4-carboxylic acid IMP E 25 MG, 50 MG EP

PA 06 28000 Fusidic acid API 25 MG, 50 MG EP

PA 06 28010 ent-(24SR,17Z)-16a-(acetoxy)-3b,11b,24,25-tetrahydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholest-17(20)-en-21-oic acid (24,25-dihydroxyfusidic acid)


PA 06 28030 ent-(17Z) -3b,11b-dihydroxy-17-[(6S)-6-(1-Hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4b,8,14-trimethyl-18-nor-5b,10a-androstan-16a-yl acetate ((24R)-24 25 dihydroxyfusidic acid 21 24 lactone)


24,25-dihydroxyfusidic acid 21,24-lactone)

PA 06 28040 ent-(17Z) -3b,11b-dihydroxy-17-[(6R)-6-(1-hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4b,8,14-trimethyl-18-nor-5b,10a-androstan-16a-yl acetate ((24S)-24,25-dihydroxyfusidic acid 21,24-lactone


PA 06 28050 ent-(17Z) -16a-(acetyloxy)-3b 11b 27-trihydroxy-4b 8 14- Imp E 25 MG 50 MG EPPA 06 28050 ent-(17Z) -16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oic acid (27-hydroxyfusidic acid)


PA 06 28060 ent-(17Z) -16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oic acid (27-hydroxyfusidic acid)


PA 06 28110 ent-(17Z) -3b,11b,16a-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21,16-lactone(16-deacetylfusidic acid 21,16-lactone)

Imp K 25 MG, 50 MG EP

PA 06 28510 Fusidate Sodium IH 25 MG, 50 MG IH

PA 06 29000 Flutamide API 25 MG 50 MG EPPA 06 29000 Flutamide API 25 MG, 50 MG EP

PA 06 29010 4-Nitro-3-(trifluoromethyl)-aniline IMP A 25 MG, 50 MG EP

PA 06 29020 N-[4-Nitro-3-(trifluoro-methyl)phenyl]acetamide IMP B 25 MG, 50 MG EP

PA 06 29030 N-[4-Nitro-3-(trifluoro-methyl)phenyl]propanamide IMP C 25 MG, 50 MG EP

PA 06 29040 2-Methyl-N-[3-(trifluoro-methyl)phenyl]propanamide IMP D 25 MG, 50 MG EP

PA 06 29050 2-Methyl-N-[2-nitro-5-(trifluoromethyl)phenyl]propanamide IMP E 25 MG, 50 MG EP

PA 06 29060 2-Hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide(2-Hydroxyflutamide)

IMP F 25 MG, 50 MG EP(trifluoromethyl)phenyl]propanamide(2-Hydroxyflutamide)

PA 06 29510 Trifluoromethylbenzene IH 25 MG, 50 MG IH

PA 06 29520 3-Nitrobenzotrifluoride IH 25 MG, 50 MG IH

PA 06 29530 3-Trifluoromethyl-4-nitrophenol IH 25 MG, 50 MG IH

PA 06 30000 Fluvtatin Sodium API 25 MG, 50 MG EP

PA 06 31000 Folic Acid API 25 MG, 50 MG EP

PA 06 31040 4-[[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic Acid (Pteroic Acid)


PA 06 31510 4-Aminobenzoic Acid IH 25 MG 50 MG IHPA 06 31510 4-Aminobenzoic Acid IH 25 MG, 50 MG IH

PA 06 31520 L-Glutamine IH 25 MG, 50 MG IH

PA 06 32000 Formoterol Fumarate Dihydrate API 25 MG, 50 MG EP

PA 06 33000 Furosemide API 25 MG, 50 MG EP

PA 06 33020 2,4-Dichloro-5- sulphamoylbenzoic Acid IMP B 25 MG, 50 MG EP

PA 06 33050 2,4-Dichlorobenzoic Acid IMP E 25 MG, 50 MG EP

PA 06 34000 Faropenem (Acid) API 25 MG, 50 MG EP

PA 06 34510 Faropenem Sodium IH 25 MG 50 MG IHPA 06 34510 Faropenem Sodium IH 25 MG, 50 MG IH

PA 06 35000 Fosinopril API 25 MG, 50 MG EP

PA 06 35510 Fosinopril Diacid IH 25 MG, 50 MG IH

PA 06 35520 Fosinopril Cyclohexyl Analog IH 25 MG, 50 MG IH

PA 07 01000 Gabapentin API 25 MG, 50 MG EP

PA 07 01510 2-Azpiro[4.5]decan- 3-one (3,3-Pentamethylene-4-butyrolactam)

IH 25 MG, 50 MG IH

PA 07 02000 Ganciclovir API 25 MG, 50 MG EP

PA 07 02020 (2RS)-2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-l) th ] 3 h d l P i t (G i l i

IMP B 25 MG, 50 MG EPyl)methoxy]-3-hydroxypropyl Propionate (Ganciclovir Monopropionate)

PA 07 02060 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine) IMP F 25 MG, 50 MG EP

PA 07 02090 2-Amino-9-[[2-(1-methylene-propoxy)-1-[(1-methylenepropoxy)methyl]ethoxy]-methyl]-1,9-dihydro-6H-purin-6-one (Ganciclovir Dipropionate)

IMP I 25 MG, 50 MG EP

PA 07 02100 2 [2 (P l i ) 6 1 6 dih d 9H i 9 IMP J EPPA 07 02100 2-[2-(Propanoylamino)-6-oxo-1,6- dihydro-9H-purin-9-yl]methoxy]propane-1,3- diyl dipropanoate (Ganciclovir Tripropionate)

IMP J 25 MG, 50 MG EP

PA 07 03000 Gemfibrozil API 25 MG, 50 MG EP

PA 07 03010 2,5-Dimethylphenol (p-Xylenol) IMP A 25 MG, 50 MG EP

PA 07 03080 1,3-Bis(2,5-dimethylphenoxy)-propane IMP H 25 MG, 50 MG EP

PA 07 03510 3-(2,5-Dimethylphenoxy)propyl Chloride(3-(2,5-Xylyloxy)propyl Chloride)

IH 25 MG, 50 MG IH

PA 07 03520 Gemfibrozil Isobutyl Ester IH 25 MG, 50 MG IH

PA 07 04000 Glibenclamide API 25 MG 50 MG EPPA 07 04000 Glibenclamide API 25 MG, 50 MG EP

PA 07 04010 5-Chloro-2-methoxy-N-(2-(4-sulfamoylphenyl)ethyl)benzamide


PA 07 04020 Methyl [[4-[2-[(5-Chloro-2-methoxybenzoyl)amino]ethyl]phenyl]-sulphonyl]carbamate


PA 07 04030 Ethyl [(4-Methylphenyl)sulphonyl]-carbamate Imp C 25 MG, 50 MG EP

PA 07 04510 5-Chloro-2-methoxybenzoic Acid IH 25 MG, 50 MG IH

PA 07 04520 5-Chloro-N-(2-phenylethyl)-2-methoxybenzamide IH 25 MG, 50 MG IH

PA 07 05000 Gliclazide API 25 MG 50 MG EPPA 07 05000 Gliclazide API 25 MG, 50 MG EP

PA 07 05010 4-Methylbenzenesulphonamide IMP A 25 MG, 50 MG EP

PA 07 05030 Ethyl [(4-Methylphenyl)sulphonyl]-carbamate IMP C 25 MG, 50 MG EP

PA 07 05060 1-(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(2-th l h l) l h l]

IMP F 25 MG, 50 MG EPmethylphenyl)sulphonyl]urea

PA 07 06000 Glipizide API 25 MG, 50 MG EP

PA 07 06010 5-Methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide


PA 07 06020 Cyclohexanamine IMP B 25 MG 50 MG EPPA 07 06020 Cyclohexanamine IMP B 25 MG, 50 MG EP

PA 07 06030 Ethyl [2-[4-[(cyclohexylcarbamoyl)-sulphamoyl]phenyl]ethyl]carbamate


PA 07 06040 6-Methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide


PA 07 06050 1-Cyclohexyl-3-[[4-[2-[[(6-methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- sulphonyl]urea


PA 07 06060 Ethyl [2-(4-Sulphamoylphenyl)- ethyl]carbamate IMP F 25 MG, 50 MG EP

PA 07 06070 Methyl [[4-[2-[[(5-Methylpyrazin- 2-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]- carbamate


PA 07 06080 4-[2-[(Cyclohexylcarbamoyl)amino]- ethyl]benzenesulphonamide


PA 07 06090 N-(Cyclohexylcarbamoyl)-4-[2- [(cyclohexylcarbamoyl)amino]ethyl]benzenesulphonamide


PA 07 07000 Guaifenesin API 25 MG, 50 MG EP

PA 07 07020 2-(2-methoxyphenoxy)propane-1,3-diol (B-isomer) Imp B 25 MG, 50 MG EP

PA 07 08000 L-Glutamine API 25 MG, 50 MG EP

PA 07 08510 N-Phenylacetyl-L-glutamine(Phenylacetylglutamine) IH 25 MG, 50 MG IH

PA 07 08520 Phenylacetamide IH 25 MG, 50 MG IH

PA 07 08530 D-Glutamine IH 25 MG, 50 MG IH

PA 07 09000 Glycopyrronium Bromide API 25 MG, 50 MG EP

PA 07 09020 Oxophenylacetic Acid (Benzoylformic Acid) IMP B 25 MG, 50 MG EP

PA 07 09030 (2RS)-Hydroxyphenyl- acetic Acid (Mandelic Acid) IMP C 25 MG, 50 MG EP

PA 07 09040 Benzoic Acid IMP D 25 MG, 50 MG EP

PA 07 09080 Methyl Oxophenylacetate (Methyl Benzoylformate) IMP H 25 MG, 50 MG EP

PA 07 09100 2-(RS)-Cyclopentylhydroxy- phenylacetic Acid (a-Cyclopentylmandelic Acid)


PA 07 09130 Cyclopentyl Phenyl Ketone IMP M 25 MG, 50 MG EP

PA 07 09510 Cyclopentylphenylmethanol IH 25 MG 50 MG IHPA 07 09510 Cyclopentylphenylmethanol IH 25 MG, 50 MG IH

PA 07 10000 Granisetron Hydrochloride API 25 MG, 50 MG EP

PA 07 11000 Griseofulvin API 25 MG, 50 MG EP

PA 07 12000 Guaiacol API 25 MG, 50 MG EP

PA 07 12010 Benzene-1,2-diol (Pyrocatechol) IMP A 25 MG, 50 MG EP

PA 07 12020 Phenol IMP B 25 MG, 50 MG EP

PA 07 12030 1,2-Dimethoxybenzene (Veratrole) IMP C 25 MG, 50 MG EP

PA 07 12050 Methyl Benzoate IMP E 25 MG 50 MG EPPA 07 12050 Methyl Benzoate IMP E 25 MG, 50 MG EP

PA 07 12070 4-Methoxyphenol (Mequinol) IMP G 25 MG, 50 MG EP

PA 07 12080 3-Methoxyphenol IMP H 25 MG, 50 MG EP

PA 07 13000 Guaidenesin API 25 MG, 50 MG EP

PA 07 13010 2-Methoxyphenol (Guaiacol) IMP A 25 MG, 50 MG EP

PA 07 13020 2-(2-Methoxyphenoxy)-propane-1,3-diol (B-Isomer) IMP B 25 MG, 50 MG EP

PA 07 14000 Glimepiride API 25 MG, 50 MG EP

PA 07 14010 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] phenylsulfonyl]-3-(4-cis-methylcyclohexyl)urea (" Glimepiride cis Isomer ")


( p )

PA 07 14020 N-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] benzene sulfonamide


PA 07 14030 1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) th l] h l] lf l] th b t

Imp C 25 MG, 50 MG USPethyl]phenyl]sulfonyl]-methoxy carbamate

PA 07 14040 1-[[m-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (" Glimepiride meta Isomer ")


PA 07 14090 1-[2-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) Imp I 25 MG 50 MG USPPA 07 14090 1-[2-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] phenylsulfonyl]-3-(4-methylcyclohexyl)urea (" Glimepiride ortho Isomer ")

Imp I 25 MG, 50 MG USP

PA 08 01000 Halofantrine Hydrochloride API 25 MG, 50 MG EP

PA 08 02000 Haloperidol API 25 MG, 50 MG EP

PA 08 03000 Harpagoside API 25 MG, 50 MG EP

PA 08 03510 Methyl trans-Cinnamate IH 25 MG, 50 MG IH

PA 08 04000 Heptaminol Hydrochloride API 25 MG, 50 MG EPPA 08 04000 Heptaminol Hydrochloride API 25 MG, 50 MG EP

PA 08 05000 Hexylresorcinol API 25 MG, 50 MG EP

PA 08 05010 Phenol IMP A 25 MG, 50 MG EP

PA 08 05020 Resorcinol IMP B 25 MG, 50 MG EP

PA 08 06000 Homatropine Methylbromide API 25 MG, 50 MG EP

PA 08 06030 (2RS)-2-Hydroxy-2-phenylacetic Acid (Mandelic Acid) IMP C 25 MG, 50 MG EP

PA 08 06060 Methyl (2RS)-2-Hydroxy-2-phenylacetate (Methyl Mandelate)


PA 08 07000 Hydrochlorothiazide API 25 MG, 50 MG EP

PA 08 07010 Chlorothiazide IMP A 25 MG, 50 MG EPPA 08 07010 Chlorothiazide IMP A 25 MG, 50 MG EP

PA 08 07020 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide) IMP B 25 MG, 50 MG EP

PA 08 08000 Hydrocodone Hydrogen Tartrate 2.5-Hydrate API 25 MG, 50 MG EP

PA 08 08010 Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate

IMP A 25 MG, 50 MG EPTrihydrate

PA 08 08030 Monohydrate: Codeine Monohydrate IMP C 25 MG, 50 MG EP

PA 08 08040 4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride (Oxycodone Hydrochloride)


PA 08 08050 7,8-Didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-one (Codeinone)

Imp. E 25 MG, 50 MG EPone (Codeinone)

PA 08 08060 7,8-Didehydro-4,5-epoxy-3,6-dimethoxy-17-methylmorphinan (Methylcodeine; O-Methylcodeine)


PA 08 08080 Diphenylmethanone(Benzophenone) IMP H 25 MG, 50 MG EP

PA 08 09000 Hydrocortisone (Cortisol) API 25 MG, 50 MG EPPA 08 09000 Hydrocortisone (Cortisol) API 25 MG, 50 MG EP

PA 08 09010 Prednisolone IMP A 25 MG, 50 MG EP

PA 08 09020 17,21-Dihydroxypregn-4-ene-3,11,20-trione (Cortisone) IMP B 25 MG, 50 MG EP

PA 08 09030 Hydrocortisone Acetate(Hydrocortisone 21-Acetate) IMP C 25 MG, 50 MG EP

PA 08 09040 6β,11β,17,21-Tetrahydroxy- pregn-4-ene-3,20-dione (6β-Hydroxyhydrocortisone)


PA 08 09060 17,21-Dihydroxypregn-4- ene-3,20-dione (Reichstein's Substance S)


PA 08 10000 Hydrocortisone Acetate API 25 MG, 50 MG EPy ,

PA 08 10010 11β,17,21-Trihydroxy- pregn-4-ene-3,20-dione (Hydrocortisone)


PA 08 10030 11β,17-Dihydroxy-3,20- dioxopregna-1,4-dien-21-yl Acetate (Prednisolone Acetate)


PA 08 10040 17-Hydroxy-3,11,20-Trioxo- pregn-4-en-21-yl Acetate IMP D 25 MG, 50 MG EPPA 08 10040 17 Hydroxy 3,11,20 Trioxo pregn 4 en 21 yl Acetate (Cortisone Acetate)


PA 08 11000 Hydrocortisone 17-Butyrate API 25 MG, 50 MG EP

PA 08 12000 Hydrocortisone Hydrogen Succinate API 25 MG, 50 MG EP

PA 08 12010 Hydrocortisone IMP A 25 MG, 50 MG EP

PA 08 12020 Hydrocortisone Acetate IMP B 25 MG, 50 MG EP

PA 08 13000 Hydromorphone Hydrochloride API 25 MG, 50 MG EP

PA 08 13030 Morphine Hydrochloride Trihydrate IMP C 25 MG, 50 MG EP

PA 08 14000 Hydroxychloroquine Sulphate API 25 MG, 50 MG EP

PA 08 15000 Hydroxyethyl Salicylate API 25 MG, 50 MG EPPA 08 15000 Hydroxyethyl Salicylate API 25 MG, 50 MG EP

PA 08 15010 Salicylic Acid IMP A 25 MG, 50 MG EP

PA 08 16000 Hydroxyzine Hydrochloride API 25 MG, 50 MG EP

PA 08 16010 (RS)-1-[(4-Chlorophenyl)-phenylmethyl]piperazine IMP A 25 MG, 50 MG EP

PA 08 16020 Decloxizine Dihydrochloride IMP B 25 MG, 50 MG EP

PA 08 17000 Hymecromone API 25 MG, 50 MG EP

PA 08 17010 1,3-Dihydroxybenzene (Resorcinol) IMP A 25 MG, 50 MG EP

PA 08 17510 2,4-Dihydroxyacetophenone IH 25 MG, 50 MG IH

PA 08 17520 Hymecromone Acetate IH 25 MG, 50 MG IH

PA 08 18000 Hyoscine Butylbromide API 25 MG, 50 MG EP

PA 08 18010 Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate


PA 08 18020 (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid)


PA 08 19000 Hyoscine Hydrobromide API 25 MG, 50 MG EP

PA 08 19030 9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop-2-enoate (Apohyoscine)


PA 08 19040 2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid)


PA 08 19510 Hyoscine N-Oxide Hydrobromide IH 25 MG, 50 MG IH

PA 08 20000 Hyoscyamine Sulphate API 25 MG, 50 MG EP

PA 08 20010 (2RS) 3 H d 2 h l i A id (DL T i IMP A EPPA 08 20010 (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid;Tropic Acid)


PA 08 20040 Hyoscine Hydrobromide Trihydrate IMP D 25 MG, 50 MG EP

PA 08 21000 Hydralazine API 25 MG, 50 MG EP

PA 08 21510 1-Chlorophthalazine IH 25 MG, 50 MG IH

PA 08 21520 1-Hydroxyphthalazine ("Phthalazin-1-ol") IH 25 MG, 50 MG IHPA 08 21520 1 Hydroxyphthalazine ( Phthalazin 1 ol ) IH 25 MG, 50 MG IH

PA 08 21530 S-Triazolo [3,4-a] phthalazine IH 25 MG, 50 MG IH

PA 08 21540 3-Methyl-1,2,4-triazolo [3,4-a] phthalazine IH 25 MG, 50 MG IH

PA 09 01000 Ibuprofen API 25 MG, 50 MG EP

PA 09 01020 (2RS)-2-(4-Butylphenyl)-propanoic Acid IMP B 25 MG, 50 MG EP

PA 09 01030 (2RS)-2-[4-(2-Methylpropyl)-phenyl]propanamide IMP C 25 MG, 50 MG EP

PA 09 01040 (2RS)-2-(4-Methylphenyl)-propanoic Acid IMP D 25 MG, 50 MG EP

PA 09 01050 1-[4-(2-Methylpropyl)phenyl]-ethanone IMP E 25 MG, 50 MG EP

PA 09 01060 3-[4-(2-Methylpropyl)phenyl]-propanoic Acid Imp. F 25 MG, 50 MG EPPA 09 01060 3 [4 (2 Methylpropyl)phenyl] propanoic Acid Imp. F 25 MG, 50 MG EP

PA 09 01110 (2RS)-2-(4-Formylphenyl)-propanoic acid Imp. K 25 MG, 50 MG EP

PA 09 01140 (2RS)-2-(4-Ethylphenyl)-propanic acid Imp. N 25 MG, 50 MG EP

PA 09 01150 2-[4-(1-Methylpropyl)-phenyl]propanoic Acid Imp. O 25 MG, 50 MG EP

PA 09 01160 (2RS) 2 [4 (2 Methylpropyl) phenyl]propan 1 ol Imp P 25 MG 50 MG EPPA 09 01160 (2RS)-2-[4-(2-Methylpropyl)-phenyl]propan-1-ol Imp. P 25 MG, 50 MG EP

PA 09 01510 4-Acetylbenzoic Acid IH 25 MG, 50 MG IH

PA 09 02000 Idoxuridine API 25 MG, 50 MG EP

PA 09 03000 Imidocarb Dipropionate API 25 MG, 50 MG IH

PA 09 04000 I i i H d hl id API 25 MG 50 MG IHPA 09 04000 Imipramine Hydrochloride API 25 MG, 50 MG IH

PA 09 04020 3-(5H-Dibenzo[b,f]azepin-5-yl)- N,N-dimethylpropan-1-amine (Depramine; 10,11-Dehydroimipramine)


PA 09 04010 3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1-amine Hydrochloride (Desipramine H d hl id )


Hydrochloride)

PA 09 04510 Iminodibenzyl IH 25 MG, 50 MG IH

PA 09 04520 Imipramine N-Oxide IH 25 MG, 50 MG IH

PA 09 05000 Indanazoline Hydrochloride API 25 MG 50 MG EPPA 09 05000 Indanazoline Hydrochloride API 25 MG, 50 MG EP

PA 09 05510 4-Aminoindan Hydrochloride IH 25 MG, 50 MG IH

PA 09 06000 Indapamide API 25 MG, 50 MG EP

PA 09 06510 4-Chloro-3-sulfamoylbenzoic Acid IH 25 MG, 50 MG IH

PA 09 06520 Triethylamine IH 25 MG, 50 MG IH

PA 09 06530 2-Methylindoline IH 25 MG, 50 MG IH

PA 09 07000 Indometacin API 25 MG, 50 MG EP

PA 09 07010 4-Chlorobenzoic Acid IMP A 25 MG, 50 MG EP

PA 09 08000 Indoramin Hydrochloride API 25 MG, 50 MG EPPA 09 08000 Indoramin Hydrochloride API 25 MG, 50 MG EP

PA 09 08010 3-(2-Bromoethyl)indole Imp. A 25 MG, 50 MG EP

PA 09 09000 Ipecacuanha API 25 MG, 50 MG EP

PA 09 09510 Emetine Dihydrochloride IH 25 MG, 50 MG IH

PA 09 10000 Isoamyl Benzoate API 25 MG, 50 MG EP

PA 09 11000 Isoconazole Nitrate API 25 MG, 50 MG EP

PA 09 11010 (1RS)-1-(2,4-Dichlorophenyl)- 2-(1H-imidazol-1-yl)ethanol Imp. A 25 MG, 50 MG EP

PA 09 11030 1-[(2RS)-2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)-ethyl]-1H-imidazole Nitrate (Miconazole Nitrate)


PA 09 11510 Dimethyl Isosorbide IH 25 MG, 50 MG IH

PA 09 12000 Isoflurane API 25 MG, 50 MG EP

PA 09 12060 Acetone Imp. F 25 MG, 50 MG EP

PA 09 13000 Isosorbide API 25 MG, 50 MG EP

PA 09 13020 Isosorbide Mononitrate Imp B 25 MG, 50 MG EP

PA 09 13510 Isoxsuprine Hydrochloride IH 25 MG, 50 MG IH

PA 09 14000 Itraconazole API 25 MG, 50 MG EP

PA 09 14010 4-[4-[4-(4-Methoxyphenyl)piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one


PA 09 14020 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(4H-1,2,4-triazol-4-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-t i l 3


triazol-3-one

PA 09 14030 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl-2,4-dihydro-3H-1,2,4-triazol-3-one


PA 09 14040 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one


one

PA 09 14050 4-[4-[4-[4-[[trans-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one

Imp E 25 MG, 50 MG

PA 09 14060 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-tria ol 1 lmeth l) 1 3 dio olan 4

Imp. F 25 MG, 50 MG EPtriazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-3H-1,2,4-triazol-3-one

PA 09 14070 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro-3H-1,2,4-triazol-3-one


triazol-3-one

PA 09 15000 Imipenem API 25 MG, 50 MG EP

PA 09 15510 Imipenem Combination with Cilastatin Sodium IH 25 MG, 50 MG IH

PA 09 16000 Irbesartan API 25 MG, 50 MG EP

PA 09 16510 Irbesartan-d3 IH 25 MG, 50 MG IH

PA 09 16010 1-pentanoylamino-cyclopentanecarboxylic acid [2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amide ;Irbesartan Metabolite "SR-49498"


PA 09 16520 Irbesartan N1-Trityl Impurity IH 25 MG 50 MG IHPA 09 16520 Irbesartan N1-Trityl Impurity

2-Butyl-3-[[4-[2-(2-trityl-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one

IH 25 MG, 50 MG IH

PA 09 16530 Irbesartan Lactam Impurity

2-Butyl-4-spirocyclopentane-2-imidazolin-5-one

IH 25 MG, 50 MG IH

uty sp ocyc ope ta e da o 5 o ehydrochloride

PA 09 16540 Irbesartan Bromo Impurity

5-(4'-(Bromomethyl)(1,1'-biphenyl)-2-yl)-1-trityl-1H-tetrazole

IH 25 MG, 50 MG IH

PA 09 16550 Irbesartan Cyano Impurity IH 25 MG, 50 MG IH

4'-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]biphenyl-2-carbonitrile

PA 09 17000 Irinotecan API 25 MG, 50 MG IH

PA 09 17510 Irinotecan Hydrochloride Trihydrate IH 25 MG, 50 MG IH

PA 09 17520 Irinotecan Acid Sodium Salt IH 25 MG, 50 MG IH

PA 09 17530 Irinotecan 12-Hydroxy Impurity IH 25 MG, 50 MG IH

PA 09 17540 Irinotecan 2-Hydroxy Impurity IH 25 MG, 50 MG IH

PA 09 17550 Irinotecan Lactone Impurity IH 25 MG, 50 MG IH

PA 09 17560 Irinotecan Descarbonyl Impurity IH 25 MG, 50 MG IH

PA 09 17570 Irinotecan Keto Impurity IH 25 MG, 50 MG IH

PA 10 01000 Josamycin API 25 MG, 50 MG EP

PA 11 01000 Ketamine Hydrochloride API 25 MG, 50 MG EP

PA 11 01010 1-[(2-Chlorophenyl)(methylimino)methyl]cyclopentanol Imp. A 25 MG, 50 MG EP

PA 11 01020 (2RS)-2-(2-Chlorophenyl)-2-hydroxycyclohexanone Imp. B 25 MG, 50 MG EP

PA 11 02000 Ketoconazole API 25 MG, 50 MG EP

PA 11 03000 Ketoprofen API 25 MG 50 MG EPPA 11 03000 Ketoprofen API 25 MG, 50 MG EP

PA 11 03010 1-(3-Benzoylphenyl)ethanone (3-Acetylbenzophenone) Imp. A 25 MG, 50 MG EP

PA 11 03020 (3-Benzoylphenyl)acetic Acid Imp. B 25 MG, 50 MG EP

PA 11 03030 3-[(1RS)-1-Carboxyethyl]- benzoic Acid Imp. C 25 MG, 50 MG EP

PA 11 03040 (2RS)-2-[3-(4-Methylbenzoyl)- phenyl]propanoic Acid Imp. D 25 MG, 50 MG EP

PA 11 03050 (2RS)-2-(3-Benzoylphenyl)- propanamide Imp. E 25 MG, 50 MG EP

PA 11 03060 (2RS)-2-(3-Benzoylphenyl)-propanenitrile Imp. F 25 MG, 50 MG EP

PA 11 03070 3-[(1RS)-1-Cyanoethyl]-benzoic Acid Imp. G 25 MG, 50 MG EP,

PA 11 03080 3-(Cyanomethyl)benzoic Acid Imp. H 25 MG, 50 MG EP

PA 11 03090 (3-Benzoylphenyl)ethanenitrile Imp. I 25 MG, 50 MG EP

PA 11 03110 (2RS)-2-[3-(2,4-Dimethylbenzoyl)-phenyl]propanoic Acid Imp. J 25 MG, 50 MG EP

PA 11 03510 3-Ethylbenzophenone IH 25 MG 50 MG EPPA 11 03510 3-Ethylbenzophenone IH 25 MG, 50 MG EP

PA 11 03520 3-(1-Hydroxyethyl)benzophenone IH 25 MG, 50 MG EP

PA 11 03530 3-Methylbenzophenone IH 25 MG, 50 MG EP

PA 11 03540 3-(1-Methoxyethyl)benzophenone IH 25 MG, 50 MG EP

PA 11 04000 Ketorolac Trometamol API 25 MG, 50 MG EP

PA 11 04010 (1RS)-5-benzoyl-2,3-dihydro-1H-pyrrolizin-1-ol ("Ketorolac 1-Hydroxy Impurity")


PA 11 04020 (1RS)-5-benzoyl-2,3-dihydro-1H-pyrrolizin-1-one ("Ketorolac 1-Keto Impurity")


PA 11 04030 (1RS)-6-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic id

Imp C 25 MG, 50 MG EPacid ("ketorolac 6-Benzoyl Isomer")

PA 11 04040 (1RS)-5-benzoyl-1-methoxy-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid ("Ketorolac 1-Methoxy Impurity")


PA 11 04050 (1RS)-5-benzoyl-N-[2-hydroxy-1,1-bis(hydroxymethyl)ethyl]-2 3 dihydro 1H pyrrolizine 1 carboxamide

Imp E 25 MG, 50 MG EP2,3-dihydro-1H-pyrrolizine-1-carboxamide ("Ketorolac Amide Impurity")

PA 11 04060(1RS)-7-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid ("Ketorolac 7-Benzoyl Isomer")


PA 11 04070 methyl (1RS)-5-benzoyl-1-hydroxy-2,3-dihydro-1H-pyrrolizine-1-carboxylate ("Ketorolac 1-Hydroxy Methyl Ester")


PA 11 04080 methyl (1RS)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylate ("Ketorolac Methyl Ester")


PA 11 04090 phenyl(2,3-dihydro-1H-pyrrolizin-5-yl)methanone ("Ketorolac 1-Decarboxy Impurity")

Imp I 25 MG, 50 MG EP

PA 11 04100 ethyl (1RS)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylate ("Ketorolac Ethyl Ester")


PA 11 04510 Ketorolac 4-Hydroxy Metabolite IH 25 MG, 50 MG IH,

PA 11 05000 Ketotifen Hydrogen Fumarate API 25 MG, 50 MG EP

PA 11 06000 Ketotifen API 25 MG, 50 MG EP

PA 11 06010 4-(4H-benzo[4,5]cyclohepta-[1,2-b]thiophen-4-ylidene)-1-methylpiperidine


PA 11 06020 (4RS)-10-Methoxy-4-(1-methylpiperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-ol


PA 11 06030 (4RS)-4-hydroxy-4-(1-methyl-piperidin-4-yl)-4,9-dihydro-10H-benzo[4,5]-cyclohepta[1,2-b]thiophen-10-one


PA 11 06040 4-[(aR)-1-Methylpiperidin-4-ylidene]-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one N-Oxide (Ketotifen N-Oxide


PA 11 07000 Ketorolac (Acid) API 25 MG, 50 MG EP

PA 12 01000 Lacidipine API 25 MG 50 MG EPPA 12 01000 Lacidipine API 25 MG, 50 MG EP

PA 12 01010 Ethyl Methyl (E )-4-{2-[2-(tert -Butoxycarbonyl) vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate


PA 12 01020 Diethyl (E )-4-{2-[2-(tert -Butoxycarbonyl) vinyl]phenyl}-2,6-dimethylpyridine-3,5-dicarboxylate


PA 12 02000 Lamotrigine API 25 MG, 50 MG EP

PA 12 02010 3-Amino-6-(2,3-dichlorophenyl)- 1,2,4-triazin-5(4H)-one Imp. A 25 MG, 50 MG EP

PA 12 02030 (2Z)-[2-(Diaminomethylidene)-diazanylidene](2,3-dichlorophenyl)acetonitrile


PA 12 02050 2,3-Dichlorobenzoic Acid Imp. E 25 MG, 50 MG EPPA 12 02050 2,3 Dichlorobenzoic Acid Imp. E 25 MG, 50 MG EP

PA 12 03000 Lansoprazole API 25 MG, 50 MG EP

PA 12 03010 2-[(RS)-[[3-Methyl-1-oxido-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]-sulphinyl]-1H-benzimidazole (LansoprazoleN-Oxide)


PA 12 03020 L l S lf I B EPPA 12 03020 Lansoprazole Sulfone Imp B 25 MG, 50 MG EP

PA 12 03030 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy) pyridin-2-yl]methyl]sulphanyl]-1Hbenzimidazole


PA 12 03040 1H-Benzimidazol-2-ol IMP D 25 MG, 50 MG EP

PA 12 03050 1H Benzimidazole 2 thiol IMP E 25 MG 50 MG EPPA 12 03050 1H-Benzimidazole-2-thiol IMP E 25 MG, 50 MG EP

PA 12 03060 2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl)methyl]sulphinyl]-1H-benzimidazole


PA 12 03510 Lansoprazole Sodium IH 25 MG, 50 MG IH

PA 12 03520 Lansoprazole Sulfone N-Oxide IH 25 MG 50 MG IHPA 12 03520 Lansoprazole Sulfone N-Oxide IH 25 MG, 50 MG IH

PA 12 03530 Lansoprazole Intermediate-LSP08 IH 25 MG, 50 MG IH

PA 12 03540 Lansoprazole Intermediate-LSP09 IH 25 MG, 50 MG IH

PA 12 03550 4-Ethoxyacetophenone IH 25 MG, 50 MG EP

PA 12 04000 Leflunomide API 25 MG, 50 MG EP

PA 12 04020 (2Z)-2-Cyano-3-hydroxy-N-[4- (trifluoromethyl)phenyl]but-2-enamide (Teriflunomide)


PA 12 04030 5-Methyl-N-[3-(trifluoromethyl)-phenyl]isoxazole-4-carboxamide


PA 12 04060 5 M th l N [2 (t ifl th l) h l]i l 4 I F 2 G 0 G EPPA 12 04060 5-Methyl-N-[2-(trifluoromethyl)-phenyl]isoxazole-4-carboxamide


PA 12 04070 5-Methyl-N-(4-methylphenyl)-isoxazole-4-carboxamide Imp. G 25 MG, 50 MG EP

PA 12 05000 Levodopa API 25 MG, 50 MG EP

PA 12 05020 (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic Acid (Tyrosine) IMP B 25 MG, 50 MG EP

PA 12 05510 4-Hydroxy-3-methoxymandelic Acid IH 25 MG, 50 MG IH

PA 12 06000 Levonorgestrel API 25 MG, 50 MG EP

PA 12 07000 Lidocaine Hydrochloride Monohydrate API 25 MG, 50 MG EP,

PA 12 08000 Lidocaine API 25 MG, 50 MG EP

PA 12 08010 2,6-Dimethylaniline Imp. A 25 MG, 50 MG EP

PA 12 08020 2-(Diethylazinoyl)-N -(2,6-dimethylphenyl)acetamide (Lidocaine N2-Oxide

Imp. B 25 MG, 50 MG EP(

PA 12 08030 N-(2,6-Dimethylphenyl)- acetamide Imp. C 25 MG, 50 MG EP

PA 12 08040 N-(2,6- Dimethylphenyl)-2-(ethylamino)acetamide Hydrochloride (Monoethylglycinexylidide Hydrochloride)


PA 12 08050 2 2' (A di l)bi [N (2 6 di th l h l) t id ] I E EPPA 12 08050 2,2'-(Azanediyl)bis[N-(2,6-dimethylphenyl)-acetamide] Hydrochloride


PA 12 08060 2-(Diethylamino)-N-(2,3-dimethylphenyl)acetamide Hydrochloride


PA 12 08070 N-(2,6-Dimethylphenyl)-2-[(1-methylethyl)amino]-acetamide Hydrochloride


PA 12 08080 2-Chloro-N -(2,6-dimethylphenyl)-acetamide Imp. H 25 MG, 50 MG EP

PA 12 08110 N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride

Imp. K 25 MG, 50 MG EP

PA 12 09000 Liothyronine Sodium API 25 MG, 50 MG EP

PA 12 10000 Liothyronine API 25 MG, 50 MG EPy ,

PA 12 11000 Lisinopril Dihydrate API 25 MG, 50 MG EP

PA 12 11010 (2RS)-2-Amino-4-phenylbutanoic-acid Imp. A 25 MG, 50 MG EP

PA 12 12000 Loperamide Hydrochloride API 25 MG, 50 MG EP

PA 12 12030 4-(4-Chlorophenyl)piperidin-4-ol IMP C 25 MG, 50 MG EP

PA 12 12080 4-[4-(4-chlorophenyl)-3,6-dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2-diphenylbutanamide


PA 12 13000 Loratadine API 25 MG, 50 MG EP

PA 12 13010 Ethyl 4-[(11RS )-8-Chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate


PA 12 13020 8-Chloro-5,6-dihydro-11H benzo[5.6]cyclohepta[1,2-b]pyridin- Imp. B 25 MG, 50 MG EPPA 12 13020 8 Chloro 5,6 dihydro 11H benzo[5.6]cyclohepta[1,2 b]pyridin11-one


PA 12 13030 Ethyl 4-(4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate


PA 12 13040 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H- Imp. D 25 MG, 50 MG EPbenzo[5,6]cyclohepta-[1,2-b]pyridine (Descarboethoxyloratadine; Desloratadine)

,

PA 12 13050 Ethyl 4-[(11RS)-8-chloro-6,11-dihydro -5H-benzo[5,6] cyclohepta[1,2-b] pyridin-11-yl]-3,6-dihydropyridine-1(2H)-carboxylate


PA 12 13060 Ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo [5 6] l h t [1 2 b] idi 11 l] i idi 1 b l t

Imp F 25 MG, 50 MG EP[5,6] cyclohepta [1,2-b]pyridin-11-yl]piperidine-1-carboxylate

PA 12 13070 8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta-[1,2-b]pyridine


PA 12 13080 Ethyl 4-Oxopiperidine-1-carboxylate (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin-4-yl)-6,11-dihydro-5H-

Imp. H 25 MG, 50 MG EPhydroxy 11 (1 methylpiperidin 4 yl) 6,11 dihydro 5Hbenzo[5,6]cyclohepta[1,2-b]pyridine

PA 12 13040 11-Hydroxy N-Methyl Dihydrodesloratadine Imp D 25 MG, 50 MG USP

PA 12 13050 4,8-Dichloro-6,11-dihydro-5H-benzo[5,6] cyclohepta[1,2-b]pyridin-11-one


PA 12 13510 (11RS) 8 Chloro 11 hydroxy 11 (1 methylpiperidin 4 yl) IH 25 MG 50 MG IHPA 12 13510 (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin- 4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2- b]pyridine

IH 25 MG, 50 MG IH

PA 12 13520 Loratadine N-Acetyl Impurity

8-Chloro-6,11-dihydro-11-(N-acetyl-4-piperinylidene)-5H-benzo[5,6]cyclohepta[1,2-b] pyridine

IH 25 MG, 50 MG IH

PA 12 13530 Loratadine N-Formyl Impurity

8-Chloro-6,11-dihydro-11-(N-formyl-4-piperinylidene)-5H-benzo[5,6]cyclohepta[1,2-b] pyridine

IH 25 MG, 50 MG IH

PA 12 13540 Loratadine 3-Hydroxy Impurity IH 25 MG, 50 MG IHy y p y

8-Chloro-3-hydroxy-6,11-dihydro-11-[N-ethoxycarbonyl-4-piperidylidene]-5H-benzo[5,6] cyclohepta[1,2-b]pyridine

,

PA 12 13550 Loratadine N-Desethoxycarbonyl 3-Hydroxy Impurity; Desloratadine 3-Hydroxy Impurity 8-Chloro-3-hydroxy-6,11-dihydro-11-(4-piperinylidene)-5H-b [5 6] l h t [1 2 b] idi

IH 25 MG, 50 MG IH

benzo[5,6]cyclohepta[1,2-b] pyridine

PA 12 13560 Desloratadine Isomer; Iso Desloratadine

8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

IH 25 MG, 50 MG IH

PA 12 14000 Lorazepam API 25 MG 50 MG EPPA 12 14000 Lorazepam API 25 MG, 50 MG EP

PA 12 15000 Losartan Potsium API 25 MG, 50 MG EP

PA 12 15040 2-Butyl-4-chloro-1H -imidazole-5-carbaldehyde IMP D 25 MG, 50 MG EP

PA 12 15050 5-(4'-Methylbiphenyl-2-yl)-1H- tetrazole Imp. E 25 MG, 50 MG EP

PA 12 15060 5-[4'[[2-Butyl-4-chloro-5-[[(1-methylethyl)oxy]methyl]-1H-imidazol-1-yl]-methyl]biphenyl-2-yl]-1H-tetrazole (Losartan Isopropyl Ether)


PA 12 15070 Triphenylmethanol IMP G 25 MG, 50 MG EP

PA 12 15080 [2-Butyl-4-chloro-1-[[2'-[2-(triphenylmethyl)-2H-tetrazol-5-yl]biphenyl-4-yl]methyl]-1H-imidazol-5-yl]methanol


PA 12 15100 [2-Butyl-4-chloro-1-[[2'-(1H- tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- imidazol-5-yl]methyl Acetate

Imp. J 25 MG, 50 MG EP

PA 12 15510 Losartan Methyl Ether IH 25 MG, 50 MG IH

PA 12 16000 Lovtatin API 25 MG, 50 MG EP

PA 12 16010 (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]-ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Mevtatin)


PA 12 17000 Levetiracetam API 25 MG, 50 MG EP

PA 12 17010 (2RS) 2 (2 O lidi 1 l)b t i id I APA 12 17010 (2RS)-2-(2-Oxopyrrolidin-1-yl)butanoic acid Imp A 25 MG, 50 MG

PA 12 17020 (2Z)-2-(2-Oxopyrrolidin-1-yl)but-2-enamide Imp B 25 MG, 50 MG

PA 12 17030 Pyridin-2-ol ; 2-Pyridinol Imp C 25 MG, 50 MG

PA 12 17040 (2R) 2 (2 O op rrolidin 1 l)b tanamide [" (R) etiracetam "] Imp D 25 MG 50 MGPA 12 17040 (2R)-2-(2-Oxopyrrolidin-1-yl)butanamide [" (R)-etiracetam "] Imp D 25 MG, 50 MG

PA 12 18000 Levofloxacin API 25 MG, 50 MG EP

PA 12 18510 N-Desmethyl Levofloxacin IH 25 MG, 50 MG IH

PA 12 19000 Levothyroxine Sodium API 25 MG, 50 MG EP

PA 12 19510 Levothyroxine Ethyl Ester IH 25 MG, 50 MG IH

PA 12 19520 Levothyroxine Methyl Ester IH 25 MG, 50 MG IH

PA 12 20000 Lisinopril API 25 MG, 50 MG EP

PA 12 20020 (4-methylbenzenesulphonic acid Imp B 25 MG, 50 MG EP

PA 12 20030 (2S)-2-[(3S,8aS)-3-(4-aminobutyl)-1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-phenylbutanoic acid


p y("S,S,S-diketopiperazine")

PA 12 20040 (2S)-2-[(3S,8aR)-3-(4-aminobutyl)-1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-phenylbutanoic acid ("R,S,S-diketopiperazine")


PA 12 20050 (2S)-1-[(2S)-6-amino-2-[[(1R)-1-carboxy-3-phenylpropyl]amino]hexanoyl] pyrrole-2-carboxylic acid ("Lisinopril R,S,S-Isomer")


PA 12 20060 (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino] hexanoyl]pyrrole-2-carboxylic acid ("Lisinopril Cyclohexyl Analog")


PA 12 21000 Losartan API 25 MG, 50 MG EP

PA 12 21010 2-Butyl-4-chloro-1H-imidazole-5-methanol Imp A 25 MG, 50 MG EP

PA 12 21020 p-(o-1H-tetrazol-5-ylphenyl)benzyl alcohol Imp B 25 MG, 50 MG EP

PA 12 21030 Losartan Isomer ; 2-Butyl-5-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-4-methanol


PA 12 21040 2-Butyl-4-chloro-1H-imidazole-5-carbaldehyde Imp D 25 MG, 50 MG EP

PA 12 21050 unknown Imp E 25 MG, 50 MG EP

PA 12 21060 Losartan Isopropyl Ether Imp F 25 MG 50 MG EPPA 12 21060 Losartan Isopropyl Ether Imp F 25 MG, 50 MG EP

PA 12 21070 Triphenylmethanol; Candesartan Trityl Alcohol Impurity Imp G 25 MG, 50 MG EP

PA 12 21080 N-Trityl Losartan ; N-Triphenylmethyl Losartan Imp H 25 MG, 50 MG EP

PA 12 21090 O-Trityl Losartan ; O-Triphenylmethyl Losartan Imp I 25 MG, 50 MG EP

PA 12 21100 O-Acetyl Losartan Imp J 25 MG, 50 MG EP

PA 12 21110 Losartan Aldehyde Imp K 25 MG, 50 MG EP

PA 12 21510 Losartan Monopotassium Salt IH 25 MG, 50 MG IH

PA 12 21520 Losartan Carboxylic Acid IH 25 MG, 50 MG IH

PA 12 21530 5-(4'-(Bromomethyl)(1,1'-biphenyl)-2-yl)-1-trityl-1H-tetrazole IH 25 MG, 50 MG IH

PA 12 21540 Trityl Methyl Ether IH 25 MG 50 MG IHPA 12 21540 Trityl Methyl Ether IH 25 MG, 50 MG IH

PA 12 22000 Lovastatin API 25 MG, 50 MG EP

PA 12 22010 Mevastatin ; Compactin Imp A 25 MG, 50 MG EP

PA 12 22020 Lovastatin Hydroxy Acid Sodium Salt Imp B 25 MG 50 MG EPPA 12 22020 Lovastatin Hydroxy Acid Sodium Salt Imp B 25 MG, 50 MG EP

PA 12 22030 Anhydro Lovastatin Imp C 25 MG, 50 MG EP

PA 12 22510 Lovastatin Anhydro Acid Sodium Salt IH 25 MG, 50 MG IH

PA 12 22040 L t ti Di I D EPPA 12 22040 Lovastatin Dimer Imp D 25 MG, 50 MG EP

PA 12 22010 Dihydro Lovastatin Imp A 25 MG, 50 MG USP

PA 12 22060 Lovastatin Epi Isomer ; epi-Lovastatin ; Imp F 25 MG, 50 MG EP

PA 13 01000 Maprotiline Hydrochloride API 25 MG 50 MG EPPA 13 01000 Maprotiline Hydrochloride API 25 MG, 50 MG EP

PA 13 01030 3-(9,10-Ethanoanthracen-9(10H)-yl)propan-1-amine Hydrochloride


PA 13 01050 3-(9,10-Ethanoanthracen-9(10H)-yl)-N,Ndimethylpropan-1-amine Hydrochloride


PA 13 02000PA 13 02000 Mebendazole API 25 MG, 50 MG EP

PA 13 02010 (2-Amino-1H -benzimidazol-5yl)phenylmethanone Imp. A 25 MG, 50 MG EP

PA 13 02020 (2-Hydroxy-1H-benzimidazol-5- yl)phenylmethanone Imp. B 25 MG, 50 MG EP

PA 13 02030 (2 A i 1 th l 1H b i id l 5 l) h l th I C EPPA 13 02030 (2-Amino-1-methyl-1H -benzimidazol-5-yl)phenylmethanone Imp. C 25 MG, 50 MG EP

PA 13 02040 Methyl (5-Benzoyl-1-methyl-1H -benzimidazol-2-yl)carbamate Imp. D 25 MG, 50 MG EP

PA 13 02050 Ethyl (5-Benzoyl-1H -benzimidazol-2-yl)carbamate Imp. E 25 MG, 50 MG EP

PA 13 02060 Methyl [5 (4 Methylbenzoyl) 1H benzimidazol 2 yl]carbamate Imp F 25 MG 50 MG EPPA 13 02060 Methyl [5-(4-Methylbenzoyl)-1H -benzimidazol-2-yl]carbamate Imp. F 25 MG, 50 MG EP

PA 13 03000 Mebeverine Hydrochloride API 25 MG, 50 MG EP

PA 13 03010 4-Methoxyphenylacetone Imp. A 25 MG, 50 MG EP

PA 13 03040 3,4-Dimethoxybenzoic Acid (Veratric Acid) IMP D 25 MG, 50 MG EP

PA 13 04000 Mechlorethamine Hydrochloride API 25 MG, 50 MG EP

PA 13 05000 Meclofenoxate Hydrochloride API 25 MG, 50 MG EP

PA 13 05510 (4-Chlorophenoxy)acetic Acid IH 25 MG, 50 MG IH

PA 13 06000 Meclozine Dihydrochloride API 25 MG, 50 MG EPy ,

PA 13 06020 (RS )-(4-Chlorophenyl)-(phenyl)methanol (4-Chlorobenzhydrol)


PA 13 06030 (4-Chlorophenyl)-phenylmethanone (4-Chlorobenzophenone Imp. C 25 MG, 50 MG EP

PA 13 06050 1 (Diphenylmethyl) 4 (3 methylbenzyl)piperazine Imp E 25 MG 50 MG EPPA 13 06050 1-(Diphenylmethyl)- 4-(3-methylbenzyl)piperazine Imp. E 25 MG, 50 MG EP

PA 13 06060 1,4-Bis[(4-chlorophenyl)- phenylmethyl]piperazine Imp. F 25 MG, 50 MG EP

PA 13 06080 1-[(RS )-(4-Chlorophenyl)-phenylmethyl]piperazine ((RS)-1-[(4-Chlorophenyl)-phenylmethyl]piperazine)


PA 13 06510 Meclozine N-Oxide IH 25 MG 50 MG IHPA 13 06510 Meclozine N-Oxide IH 25 MG, 50 MG IH

PA 13 06520 N-(3-Methylbenzyl)piperazine Dihydrochloride IH 25 MG, 50 MG IH

PA 13 07000 Medroxyprogesterone API 25 MG, 50 MG EP

PA 13 08000 Medroxyprogesterone Acetate API 25 MG, 50 MG EP

PA 13 08070 6-Methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate (Megestrol Acetate)


PA 13 08080 3,20-Dioxopregn-4-en-17-yl Acetate (Hydroxyprogesterone Acetate)


PA 13 09000 Mefenamic Acid API 25 MG, 50 MG EP

PA 13 09010 2,3-Dimethylaniline IMP A 25 MG, 50 MG EP

PA 13 09020 N-(2,3-Dimethylphenyl)-2-[(2,3-dimethylphenyl)amino]benzamide


PA 13 09030 2-Chlorobenzoic Acid IMP C 25 MG, 50 MG EP

PA 13 09040 Benzoic Acid IMP D 25 MG 50 MG EPPA 13 09040 Benzoic Acid IMP D 25 MG, 50 MG EP

PA 13 10000 Megestrol Acetate API 25 MG, 50 MG EP

PA 13 10010 6a-Methyl-3,20-dioxopregn-4-en-17-yl Acetate (Medroxyprogesterone Acetate)


PA 13 11000 Meloxicam API 25 MG, 50 MG EP

PA 13 11010 Ethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide


PA 13 11020 5-Methylthiazol-2-amine IMP B 25 MG, 50 MG EP

PA 13 11050 Methyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide


PA 13 11060 I l 4 H d 2 th l 2H 1 2 b thi i 3 I F EPPA 13 11060 Isopropyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide)


PA 13 12000 Mephenesin API 25 MG, 50 MG EP

PA 13 13000 Mephentermine Hemisulphate API 25 MG 50 MG EPPA 13 13000 Mephentermine Hemisulphate API 25 MG, 50 MG EP

PA 13 14000 Mepivacaine Hydrochloride API 25 MG, 50 MG EP

PA 13 14010 2,6-Dimethylaniline IMP A 25 MG, 50 MG EP

PA 13 14020 (RS)-N-(2,6- Dimethylphenyl)piperidine-2-carboxamide Hydrochloride


PA 13 14030 N-(2,6-Dimethylphenyl)-pyridine-2-carboxamide Imp. C 25 MG, 50 MG EP

PA 13 14510 Mepivacaine N-Oxide IH 25 MG, 50 MG IH

PA 13 15000 Mepyramine Maleate API 25 MG, 50 MG EP

PA 13 15010 N-(4-Methoxybenzyl)pyridin-2-amine Imp. A 25 MG, 50 MG EP

PA 13 15020 4-Methoxybenzaldehyde(Anisaldehyde) IMP B 25 MG, 50 MG EP

PA 13 15030 Pyridin-2-amine IMP C 25 MG 50 MG EPPA 13 15030 Pyridin-2-amine IMP C 25 MG, 50 MG EP

PA 13 15510 Mepyramine N-Oxide Dihydrochloride IH 25 MG, 50 MG IH

PA 13 16000 Mequinol API 25 MG, 50 MG EP

PA 13 17000 Mesalazine API 25 MG, 50 MG EP

PA 13 17010 4-Aminophenol IMP A 25 MG, 50 MG EP

PA 13 17020 3-Aminophenol IMP B 25 MG, 50 MG EP

PA 13 17030 2-Aminophenol IMP C 25 MG, 50 MG EP

PA 13 17040 3-Aminobenzoic Acid IMP D 25 MG, 50 MG EP

PA 13 17060 3-Amino-2-hydroxybenzoicAcid (3-Aminosalicylic Acid) IMP F 25 MG, 50 MG EP

PA 13 17070 2,5-Dihydroxybenzoic Acid IMP G 25 MG, 50 MG EP

PA 13 17110 Aniline IMP K 25 MG 50 MG EPPA 13 17110 Aniline IMP K 25 MG, 50 MG EP

PA 13 17120 2-Chlorobenzoic Acid IMP L 25 MG, 50 MG EP

PA 13 17130 2-Chloro-5-nitrobenzoic Acid IMP M 25 MG, 50 MG EP

PA 13 17140 2 Hydroxy 5 nitrobenzoic Acid (5 Nitrosalicylic Acid) IMP N 25 MG 50 MG EPPA 13 17140 2-Hydroxy-5-nitrobenzoic Acid (5-Nitrosalicylic Acid) IMP N 25 MG, 50 MG EP

PA 13 17150 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) IMP O 25 MG, 50 MG EP

PA 13 18000 Metamizole Sodium API 25 MG, 50 MG EP

PA 13 18010 4-Formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H- Imp. A 25 MG, 50 MG EPy , y p y , ypyrazol-3-one (4-Formylaminophenazone

p 25 MG, 50 MG

PA 13 18020 4-Amino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (Ampyrone)


PA 13 18030 4-Methylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride (4-Methylaminophenazone Hydrochloride


PA 13 18040 4-Dimethylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (4,4-Dimethylaminophenazone)


PA 13 18510 4-Acetylaminophenazone IH 25 MG, 50 MG IH

PA 13 19000 Metformin Hydrochloride API 25 MG, 50 MG EP

PA 13 19040 1,3,5-Triazine-2,4,6-triamine (Melamine) IMP D 25 MG, 50 MG EP

PA 13 19060 N-Methylmethanamine hydrochloride IMP F 25 MG, 50 MG EP

PA 13 20000 Methamphetamine Hydrochloride API 25 MG, 50 MG EP

PA 13 21000 Methotrexate API 25 MG, 50 MG EP

PA 13 21010 (2,4-Diaminopteridin-6-yl)methanol Hydrochloride IMP A 25 MG, 50 MG EP

PA 13 22000 Methoxsalen API 25 MG, 50 MG EP

PA 13 22510 5-Methoxypsoralen (Bergapten) IH 25 MG, 50 MG IHPA 13 22510 5 Methoxypsoralen (Bergapten) IH 25 MG, 50 MG IH

PA 13 23000 Methyl Nicotinate API 25 MG, 50 MG EP

PA 13 23010 Nicotinic Acid IMP A 25 MG, 50 MG EP

PA 13 24000 Methyl Parahydroxybenzoate API 25 MG, 50 MG EP

PA 13 24010 4-Hydroxybenzoic Acid IMP A 25 MG, 50 MG EPPA 13 24010 4 Hydroxybenzoic Acid IMP A 25 MG, 50 MG EP

PA 13 24020 Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate) IMP B 25 MG, 50 MG EP

PA 13 24030 Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate) IMP C 25 MG, 50 MG EP

PA 13 24040 Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate) IMP D 25 MG, 50 MG EP

PA 13 25000 Methylprednisolone API 25 MG, 50 MG EP

PA 13 25010 17,21-Dihydroxy-6a-methylpregna-1,4-diene-3,11,20-trione IMP A 25 MG, 50 MG EP

PA 13 26000 Methylprednisolone Acetate API 25 MG, 50 MG EP

PA 13 26020 Methylprednisolone IMP B 25 MG, 50 MG EP

PA 13 26050 Prednisolone Acetate IMP E 25 MG, 50 MG EP

PA 13 26030 4-Amino-5-chloro-2-methoxybenzoic Acid Imp. C 25 MG, 50 MG EP

PA 13 26040 Methyl 4-(Acetylamino)-2-methoxybenzoate IMP D 25 MG, 50 MG EP

PA 13 26050 N,N-Diethylethane-1,2-diamine Imp. E 25 MG, 50 MG EP

PA 13 26070 N'-(4-Amino-5-chloro-2-methoxybenzoyl)-N,N-diethylethane-1,2-diamine N-Oxide (Metoclopramide N-Oxide)


PA 13 26080 4-(Acetylamino)-2-hydroxybenzoic Acid Imp. H 25 MG, 50 MG EP

PA 13 26510 Methyl 4-Amino-2-hydroxybenzoate IH 25 MG, 50 MG IH

PA 13 26520 Methyl 4-(Acetylamino)-2-hydroxybenzoate IH 25 MG, 50 MG IH

PA 13 27000 Metoprolol Succinate API 25 MG, 50 MG EP

PA 13 27010 (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol


PA 13 27020 4-(2-Methoxyethyl)phenol IMP B 25 MG, 50 MG EP

PA 13 27030 4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-benzaldehyde Hydrochloride


PA 13 27060 (2RS)-1-[(1-Methylethyl)amino]-3-phenoxypropan-2-ol Imp. F 25 MG, 50 MG EP

PA 13 27070 2-(4-Hydroxyphenyl)ethanol IMP G 25 MG, 50 MG EP( y yp y ) 25 MG, 50 MG

PA 13 27080 (2RS)-1-[4-(2-Hydroxyethyl)-phenoxy]-3-[(1-methylethyl)amino]propan-2-ol


PA 13 28000 Metoprolol Tartrate API 25 MG, 50 MG EP

PA 13 28020 4-(2-Methoxyethyl)phenol IMP B 25 MG, 50 MG EP,

PA 13 28070 2-(4-Hydroxyphenyl)ethanol IMP G 25 MG, 50 MG EP

PA 13 28080 (2RS)-1-[4-(2-hydroxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol

Imp H 25 MG, 50 MG IH

PA 13 28510 3-Chloropropane-1 2-diol IH 25 MG 50 MG IHPA 13 28510 3-Chloropropane-1,2-diol IH 25 MG, 50 MG IH

PA 13 29000 Metronidazole API 25 MG, 50 MG EP

PA 13 29010 2-Methyl-4-nitroimidazole IMP A 25 MG, 50 MG EP

PA 13 29020 4-Nitroimidazole IMP B 25 MG, 50 MG EP

PA 13 29030 2-(4-Nitro-1H-imidazol-1-yl)-ethanol Imp. C 25 MG, 50 MG EP

PA 13 29040 2-(5-Nitro-1H-imidazol-1-yl)-ethanol Imp. D 25 MG, 50 MG EP

PA 13 29050 2-(2-Methyl-4-nitro-1Himidazol-1-yl)ethanol Imp. E 25 MG, 50 MG EP

PA 13 29060 2-[2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethoxy]ethanol Imp F 25 MG, 50 MG EP

PA 13 29070 2-(2-Methyl-5-nitro-1Himidazol-1-yl)acetic Acid Imp. G 25 MG, 50 MG EP

PA 13 30000 Metronidazole Benzoate API 25 MG, 50 MG EPPA 13 30000 Metronidazole Benzoate API 25 MG, 50 MG EP

PA 13 30020 2-Methyl-5-nitroimidazole (2-Methyl-4-nitroimidazole) IMP B 25 MG, 50 MG EP

PA 13 30030 Benzoic Acid IMP C 25 MG, 50 MG EP

PA 13 31000 Mevtatin API 25 MG, 50 MG EP

PA 13 32000 Mexiletine Hydrochloride API 25 MG, 50 MG EP

PA 13 32010 2,6-Dimethylphenol IMP A 25 MG, 50 MG EP

PA 13 32020 1-(2,6-Dimethylphenoxy)propan-2-one Imp. B 25 MG, 50 MG EP

PA 13 33000 Mianserin Hydrochloride API 25 MG, 50 MG EP

PA 13 33010 2-[(2RS)-4-Methyl-2-phenylpiperazin-1-ly]phenyl]methanol IMP A 25 MG, 50 MG EP

PA 13 33030 (2-Aminophenyl)methanol IMP C 25 MG, 50 MG EP

PA 13 33510 Mianserin N-Oxide IH 25 MG, 50 MG IH

PA 13 34000 Miconazole Nitrate API 25 MG, 50 MG EP

PA 13 34030 (2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine


PA 13 35000 Miconazole API 25 MG, 50 MG EP

PA 13 35010 (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol Imp. A 25 MG, 50 MG EP

PA 13 35020 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)-ethyl]-1H-imidazole Nitrate (Econazole Nitrate)


PA 13 35030 (2RS)-2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl) ethanamine Nitrate


PA 13 35040 1-[(2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)-ethyl]-1H-imidazole Nitrate (Isoconazole Nitrate)


PA 13 35060 1-[(2RS)-2-[(3,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl) ethyl]-1H-imidazole Nitrate

Imp. F 25 MG, 50 MG EPy ]

PA 13 35070 1-[(2RS)-2-[(2,5- Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl) ethyl]-1H-imidazole Nitrate


PA 13 35080 1-[(2RS)-2-Benzyloxy-2-(2,4-dichlorophenyl)ethyl]-1Himidazole Nitrate


PA 13 35090 1-[(2RS)-2-[(2-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl) Imp. I 25 MG 50 MG EPPA 13 35090 1-[(2RS)-2-[(2-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl) ethyl]-1H-imidazole Nitrate


PA 13 35510 1-(2,4-Dichlorobenzoylmethyl)imidazole IH 25 MG, 50 MG IH

PA 13 36000 Midazolam API 25 MG, 50 MG EP

PA 13 36510 1-Methyl-3-phenylpiperazine IH 25 MG, 50 MG IH

PA 13 37000 Minoxidil API 25 MG, 50 MG EP

PA 13 37010 6-Chloropyrimidine-2,4-diamine3-Oxide Imp. A 25 MG, 50 MG EP

PA 13 37030 3-(cyanoimino)-3-(piperidin-1-yl)propanamide Imp C 25 MG, 50 MG EP

PA 13 37040 6-[[(4-methylphenyl)sulphonyl]-oxy]pyrimidine-2,4-diamine 3-oxide


PA 13 37050 6-(Piperidin-1-yl)pyrimidine-2,4-diamine (Desoxyminoxidil) Imp. E 25 MG, 50 MG EP

PA 13 38000 Mirtazapine API 25 MG, 50 MG EP

PA 13 38010 (14bRS )-2-Methyl-1,2,3,4,10-14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-Oxide


PA 13 38020 [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl]pyridin-3-yl]methanol


PA 13 38510 (2RS)-4-Methyl-1-(3-methylpyridin-2-yl)-2-phenylpiperazine IH 25 MG, 50 MG EP

PA 13 38520 1-Methyl-3-phenylpiperazine IH 25 MG, 50 MG EP

PA 13 39000 Moclobemide API 25 MG, 50 MG EP

PA 13 40000 Molsidomine API 25 MG, 50 MG EP

PA 13 40040 (14bRS)-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine


PA 13 40020 4-Nitrosomorpholine IMP B 25 MG, 50 MG EP

PA 13 41000 Mycophenolate Mofetil API 25 MG, 50 MG EP

PA 13 41010 2-(morpholin-4-yl)ethyl (4E)-6-(4,6-dihydroxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate


PA 13 41040 2-(morpholin-4-yl)ethyl (4E)-6-(4,6-dimethoxy-7-methyl-3-oxo-1,3-dihydro-isobenzofuran-5-yl)-4-methylhex-4-enoate


PA 13 41060 (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid (mycophenolic acid)


PA 13 41070 2-(morpholin-4-yl)ethyl (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate N-oxide


PA 13 41080 7-hydroxy-5-methoxy-4-methyl-6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2-yl]ethyl]isobenzofuran-1(3H)-one


PA 13 42000 Morphine Hydrochloride Trihydrate API 25 MG, 50 MG EP

PA 13 42010 Codeine Phosphate Hemihydrate Imp. A 25 MG, 50 MG EP

PA 13 42060 (17S)-7,8-Didehydro-4,5a-epoxy-17-methylmorphinan-3,6a-diol 17-Oxide (Morphine N-Oxide)


PA 13 43000 Morphine Sulphate API 25 MG, 50 MG EP

PA 13 44000 Moxifloxacin Hydrochloride API 25 MG, 50 MG EP

PA 13 45000 Meropenem Trihydrate API 25 MG, 50 MG EPPA 13 45000 Meropenem Trihydrate API 25 MG, 50 MG EP

PA 13 45510 Meropenem Combination with Sodium Carbonate IH 25 MG, 50 MG IH

PA 13 46000 Metoprolol API 25 MG, 50 MG EP

PA 13 46510 Metoprolol S ccinate IH 25 MG 50 MG IHPA 13 46510 Metoprolol Succinate IH 25 MG, 50 MG IH

PA 13 46520 Metoprolol Tartrate IH 25 MG, 50 MG IH

PA 13 46010 (Ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Imp A 25 MG, 50 MG EP

PA 13 46020 : 4-(2-Methoxyethyl)phenol Imp B 25 MG, 50 MG EP

PA 13 46030 4-[(2RS)-2-Hydroxy-3-[(1-methylethyl) amino]propoxy]benzaldehyde


PA 13 46040 (2RS)-3-[4-(2-methoxyethyl)phenoxy]propane-1,2-diol Imp D 25 MG, 50 MG EP

PA 13 46050 : (2RS)-1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol


PA 13 46060 (2RS)-1-[(1-methylethyl)amino]-3-phenoxypropan- 2-ol Imp F 25 MG, 50 MG EP

PA 13 46070 C 2-(4-Hydroxyphenyl)ethanol Imp G 25 MG, 50 MG EP

PA 13 46080 (2RS) 1 [4 (2 H d th l) h ] 3 [(1 I H EPPA 13 46080 (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2- ol ("O-Desmethyl Metoprolol")


PA 13 46100 1-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol


PA 13 46130 1,3-bis[(1-Methylethyl)amino]propan-2-ol Imp M 25 MG, 50 MG EP

PA 13 46140 (2RS)-3-[(1-methylethyl)amino]propane-1,2-diol Imp N 25 MG, 50 MG EP

PA 13 46150 1,1-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy] Imp O 25 MG, 50 MG EPPA 13 46150 1,1 [(1 Methylethyl)imino]bis[3 [4 (2 methoxyethyl)phenoxy] propan-2-ol]

Imp O 25 MG, 50 MG EP

PA 13 46520 Metoprolol Impurity BMEPP 1,3-bis[4-(2-Methoxyethyl)phenoxy]propan-2-ol

IH 25 MG, 50 MG IH

PA 13 46530 Metoprolol Epoxide Impurity 1-[2-(2-Methoxyethyl)phenyoxy]-2 3-epoxypropane

IH 25 MG, 50 MG IH1-[2-(2-Methoxyethyl)phenyoxy]-2,3-epoxypropane

PA 13 46540 Metoprolol Acid 2-[4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetic acid [56392-14-4]

IH 25 MG, 50 MG IH

PA 13 47000 Minocycline (Free Base) API 25 MG, 50 MG EPy ( ) 25 MG, 50 MG

PA 13 47510 Minocycline Hydrochloride IH 25 MG, 50 MG IH

PA 13 48000 Montelukast (Acid) API 25 MG, 50 MG EP

PA 13 48510 Montelukast Sodium IH 25 MG, 50 MG IH

PA 13 48520 2 (2 (3S (2 (7 hl 2 i li l) th l h l) 3 IH 25 MG 50 MG IHPA 13 48520 2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol

IH 25 MG, 50 MG IH

PA 13 48530 3-(Mercaptomethyl)cyclopropane acetic acid IH 25 MG, 50 MG IH

PA 13 48540 2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)-1-methoxycarbonylbenzene

IH 25 MG, 50 MG IHp py ) y y

PA 13 48550 2-(3-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-oxo-propyl)-1-methoxycarbonylbenzene

IH 25 MG, 50 MG IH

PA 13 48010 Montelukast Sulfoxide Imp A 25 MG, 50 MG USP

PA 13 48560 Montelukast Sulfone IH 25 MG 50 MG IHPA 13 48560 Montelukast Sulfone IH 25 MG, 50 MG IH

PA 13 48020 Montelukast cis Isomer Imp B 25 MG, 50 MG USP

PA 13 48050 Montelukast Methylketone Impurity Imp E 25 MG, 50 MG USP

PA 13 48060 Montelukast Methylstyrene Impurity Imp F 25 MG, 50 MG USP

PA 13 48570 : Montelukast 1,2-Diol IH 25 MG, 50 MG IH

PA 13 48580 : Montelukast Disulfide Impurity IH 25 MG, 50 MG IH

PA 13 48590 Montelukast Ether Impurity IH 25 MG, 50 MG IH

PA 13 48600 Montelukast Dicyclohexylamine IH 25 MG, 50 MG IH

PA 13 48610 Montelukast Dihydro Impurity IH 25 MG, 50 MG IH

PA 13 48620 Montelukast Lactone IH 25 MG 50 MG IHPA 13 48620 Montelukast Lactone IH 25 MG, 50 MG IH

PA 13 49000 Moxifloxacin Hydrochloride API 25 MG, 50 MG EP

PA 13 49010 1-Cyclopropyl-6,8-difluoro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid


carboxylic acid

PA 13 49020 1-Cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid


PA 13 49030 1-Cyclopropyl-8-ethoxy-6-fluoro-7-[(4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-


carboxylic acid

PA 13 49040 1-Cyclopropyl-8-fluoro-6-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo [3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid


PA 13 49050 1-Cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo [3 4-b]pyridin-6-yl]-4-oxo-1 4-dihydroquinoline-3-

Imp E 25 MG, 50 MG EP6H-pyrrolo [3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

PA 13 50000 Mycophenolate Mofetil API 25 MG, 50 MG EP

PA 13 50010 2-Morpholinoethyl-(E)-6-(1,3-dihydro-4,6-dihydroxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate


PA 13 50020 Mycophenolate Imp B 25 MG, 50 MG EP

PA 13 50030 Mycophenolate (cis Isomer) Imp C 25 MG, 50 MG EP

PA 13 50040 O-Methyl Mycophenolate Mofetil Imp D 25 MG, 50 MG EP

PA 13 50050 Mycophenolic Acid Methyl Ester Imp E 25 MG, 50 MG EPPA 13 50050 Mycophenolic Acid Methyl Ester Imp E 25 MG, 50 MG EP

PA 13 50060 Mycophenolic Acid Imp F 25 MG, 50 MG EP

PA 13 50070 Mycophenolate Mofetil N-Oxide Imp G 25 MG, 50 MG EP

PA 13 50080 (RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo- Imp H 25 MG, 50 MG EP( ) y y y y [ ( ytetrahydro-furan-5-yl)-ethyl]-3H-isobenzofuranyl-1-one

p 5 MG, 50 MG

PA 13 50510 Mycophenolate Di-Mofetil IH 25 MG, 50 MG IH

PA 13 50520 O-Desmethyl Mycophenolic Acid IH 25 MG, 50 MG IH

PA 13 50530 O-Desmethyl Mycophenolic Acid Methyl Ester IH 25 MG, 50 MG IH

PA 13 50540 O-Methyl Mycophenolic Acid IH 25 MG, 50 MG IH

PA 13 50550 O-Methyl Mycophenolic Acid Methyl Ester IH 25 MG, 50 MG IHPA 13 50550 O Methyl Mycophenolic Acid Methyl Ester IH 25 MG, 50 MG IH

PA 13 50560 Mycophenolic Hydroxy Lactone IH 25 MG, 50 MG IH

PA 13 50570 Mycophenolic Lactone Ether IH 25 MG, 50 MG IH

PA 13 50580 Mycophenolic Acid Sodium Salt IH 25 MG, 50 MG IH

PA 13 50590 Mycophenolate Dimer IH 25 MG, 50 MG IH

PA 13 50600 : Mycophenolate Dimethylamide IH 25 MG, 50 MG IH

PA 13 50610 O-Desmethyl Mycophenolate Ether IH 25 MG, 50 MG IH

PA 13 50620 O-Desmethyl Mycophenolic Ether IH 25 MG, 50 MG IH

PA 13 50630 Mycophenolate Ether IH 25 MG, 50 MG IH

PA 14 01000 Nabumetone API 25 MG, 50 MG EPPA 14 01000 Nabumetone API 25 MG, 50 MG EP

PA 14 01030 (2RS)-4-(6-Methoxynaphthalen-2-yl)-butan-2-ol Imp. C 25 MG, 50 MG EP

PA 14 01040 (E)-4-(6-Methoxynaphthalen-2-yl)-but-3-en-2-one Imp. D 25 MG, 50 MG EP

PA 14 02000 Nadolol API 25 MG, 50 MG EP

PA 14 02060 (2RS)-1-[(1,1- Dimethylethyl)amino]-3-(naphthalen-1-yloxy)- propan-2-ol Hydrochloride


PA 14 02070 (2RS)-1-[(1,1-Dimethyl- ethyl)amino]-3-[(5,6,7,8-t t h d ht l 1 l) ] 2 l H d hl id

Imp. G 25 MG, 50 MG EPtetrahydronaphtalen-1-yl)oxy]- propan-2-ol Hydrochloride

PA 14 03000 Nafcillin Sodium API 25 MG, 50 MG EP

PA 14 03510 2-Ethoxynaphthoic Acid IH 25 MG, 50 MG IH

PA 14 04000 Naloxone Hydrochloride Dihydrate API 25 MG 50 MG EPPA 14 04000 Naloxone Hydrochloride Dihydrate API 25 MG, 50 MG EP

PA 14 05000 Naltrexone Hydrochloride API 25 MG, 50 MG EP

PA 14 06000 Nandrolone API 25 MG, 50 MG EP

PA 14 07000 Nandrolone Decanoate API 25 MG, 50 MG EP

PA 14 07510 17b-Hydroxyestr-4-en-3-one(Nandrolone) IH 25 MG, 50 MG IH

PA 14 08000 Naphazoline Hydrochloride API 25 MG, 50 MG EP

PA 14 08010 N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride)


Hydrochloride)PA 14 08020 Naphthalen-1-yl)acetic Acid (1-Naphthylacetic Acid) IMP B 25 MG, 50 MG EP

PA 14 08510 Ethyl (1-Naphthyl)acetate IH 25 MG, 50 MG IH

PA 14 08520 (Naphthalen-1-yl)acetamide (1-Naphthylacetamide) IH 25 MG, 50 MG IH

PA 14 09000 Naphazoline Nitrate API 25 MG, 50 MG EP

PA 14 09010 N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride)


PA 14 09020 Naphthalen-1-yl)acetic Acid (1-Napthylacetic Acid) IMP B 25 MG, 50 MG EP

PA 14 09030 (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile) Imp. C 25 MG, 50 MG EPPA 14 09030 (Naphthalen 1 yl)acetonitrile (1 Naphthylacetonitrile) Imp. C 25 MG, 50 MG EP

PA 14 09510 Ethyl (1-Naphthyl)acetate IH 25 MG, 50 MG IH

PA 14 09520 Naphthalen-1-yl)acetamide (1-Naphthylacetamide) IH 25 MG, 50 MG IH

PA 14 10000 Naproxen API 25 MG, 50 MG EP

PA 14 10010 (2S)-2-(6-Hydroxynaphthalen-2-yl)propanoic Acid (O-Demethylnaproxen


PA 14 10020 (2S)-2-(5-Chloro-6-methoxynaphthalen- 2-yl)propanoic Acid (5-Chloronaproxen)


PA 14 10030 (2S)-2-(5-Bromo-6-methoxynaphthalen-2-yl)propanoic Acid (5 B

Imp. C 25 MG, 50 MG EP(5-Bromonaproxen

PA 14 10040 (2S)-2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic Acid (5-Iodonaproxen)


PA 14 10050 Methyl (2S )-2-(6-Methoxynaphthalen-2-yl)propanoate (NaproxenMethyl Ester)


PA 14 10060 Ethyl (2S )-2-(6-Methoxynaphthalen-2-yl)propanoate (NaproxenEthyl Ester)


PA 14 10080 6-Methoxynaphthalen-2-ol (Hydroxynerolin) Imp. H 25 MG, 50 MG EP

PA 14 10090 (6-Methoxynaphthalen-2-yl)acetic Acid (a-D th l

Imp. I 25 MG, 50 MG EPDemethylnaproxen

PA 14 10100 2-Ethyl-6-methoxynaphthalene (Ethylnerolin) Imp. J 25 MG, 50 MG EP

PA 14 10110 (1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol Imp. K 25 MG, 50 MG EP

PA 14 10120 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin Imp. L 25 MG, 50 MG EP( y p y ) ( y p 25 MG, 50 MG

PA 14 10130 2-Methoxynaphthalene (Nerolin) Imp. M 25 MG, 50 MG EP

PA 14 10140 2-Bromo-6-methoxynaphthalene Imp. N 25 MG, 50 MG EP

PA 14 11000 Naproxen Sodium API 25 MG, 50 MG EP

PA 14 11510 2-Carboxy-6-methoxynaphthalene IH 25 MG, 50 MG IH

PA 14 12000 Nateglinide API 25 MG, 50 MG EP

PA 14 13000 Nevirapine Anhydrous API 25 MG, 50 MG EPp y 25 MG, 50 MG

PA 14 13010 11-Ethyl-4-methyl-5,11-dihydro- 6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one


PA 14 13020 4-Methyl-5,11-dihydro-6H- dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one


PA 14 13030 4-Methyl-11-propyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one


PA 14 13510 3-Amino-2-chloro-4-methylpyridine IH 25 MG, 50 MG IH

PA 14 14000 Nicardipine Hydrochloride API 25 MG, 50 MG EP

PA 14 15000 Nicergoline API 25 MG, 50 MG EP

PA 14 15040 5-Bromopyridine-3-carboxylicAcid IMP D 25 MG, 50 MG EP

PA 14 16000 Nicorandil API 25 MG, 50 MG EP

PA 14 17000 Ni ti id API 25 MG 50 MG EPPA 14 17000 Nicotinamide API 25 MG, 50 MG EP

PA 14 17510 Isonicotinamide IH 25 MG, 50 MG IH

PA 14 18000 Nicotine API 25 MG, 50 MG EP

PA 14 18030 (5S)-1-Methyl-5-(pyridin-3-yl)-pyrrolidin-2-one (Cotinine) IMP C 25 MG, 50 MG EP

PA 14 18070 3-[(2S )-Piperidin-2-yl]pyridine (Anabasine) IMP G 25 MG, 50 MG EP

PA 14 19000 Nicotinic Acid API 25 MG, 50 MG EP,

PA 14 19050 Pyridine-4-carboxylic Acid (Isonicotinic Acid) IMP E 25 MG, 50 MG EP

PA 14 19510 Methyl Nicotinate IH 25 MG, 50 MG IH

PA 14 19520 Benzyl Nicotinate IH 25 MG, 50 MG IH

PA 14 20000 Nifedipine API 25 MG, 50 MG EP

PA 14 20010 Dimethyl 2,6-Dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate (Nitrophenylpyridine Analogue of Nifedipine)


PA 14 20020 Di th l 2 6 Di th l 4 (2 it h l) idi 3 5 I B EPPA 14 20020 Dimethyl 2,6-Dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylate (Nitrosophenylpyridine Analogue of Nifedipine


PA 14 20030 (E/Z-Mixture) Methyl (E/Z)-2-(2-Nitrobenzylidene)-3-oxobutanoate


PA 14 21000 Niflumic Acid API 25 MG, 50 MG EP

PA 14 21020 2-Hydroxy-N -[3-(trifluoromethyl) phenyl]pyridine-3-carboxamide


PA 14 21060 Methyl 2-[[3-(Trifluoromethyl)-phenyl]amino]pyridine-3-carboxylate (Niflumic Acid Methyl Ester)


PA 14 22000 Nimesulide API 25 MG, 50 MG EP

PA 14 22020 N-(2-Phenoxyphenyl)-methanesulphonamide Imp. B 25 MG, 50 MG EP

PA 14 22030 2-Phenoxyaniline Imp. C 25 MG, 50 MG EP

PA 14 22040 4-Nitro-2-phenoxyaniline Imp. D 25 MG, 50 MG EP

PA 14 22050 N,N-Bis(methylsulphonyl)-2- phenoxyaniline IMP. E 25 MG, 50 MG EP

PA 14 22060 N N Bi ( th l l h l) 4 it 2 h ili IMP F 25 MG 50 MG EPPA 14 22060 N,N-Bis(methylsulphonyl)-4- nitro-2-phenoxyanilin IMP. F 25 MG, 50 MG EP

PA 14 22070 4-Nitro-2-phenoxyphenol IMP. G 25 MG, 50 MG EP

PA 14 22510 2-Nitrobenzaldehyde IH 25 MG, 50 MG IH

PA 14 23000 Nizatidine API 25 MG, 50 MG EP

PA 14 23100 [2-[(dimethylamino)methyl]thiazol-4-yl]methanol Imp J 25 MG, 50 MG EP

PA 14 24000 Niflumic Acid API 25 MG 50 MG EPPA 14 24000 Niflumic Acid API 25 MG, 50 MG EP

PA 14 24010 2-Chloropyridine-3-carboxylic Acid (2-Chloronicotinic Acid) IMP A 25 MG, 50 MG EP

PA 14 24030 3-(Trifluoromethyl)aniline IMP C 25 MG, 50 MG EP

PA 14 25000 Nifuroxazide API 25 MG, 50 MG EP

PA 14 25010 4-Hydroxybenzohydrazide (p-Hydroxybenzohydrazide)


PA 14 25020 Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)

IMP B 25 MG, 50 MG EP( et y a a yd o ybe oate)

PA 14 26000 Nifursol API 25 MG, 50 MG EP

PA 14 26510 5-Nitro-2-furfural IH 25 MG, 50 MG IH

PA 14 27000 Nikethamide API 25 MG 50 MG EPPA 14 27000 Nikethamide API 25 MG, 50 MG EP

PA 14 28000 Nimodipine API 25 MG, 50 MG EP

PA 14 28010 2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate


PA 14 28020 Bis(1-methylethyl) 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


PA 14 28030 Bis(2-methoxyethyl) 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


PA 14 29000 Nitrazepam API 25 MG 50 MG EPPA 14 29000 Nitrazepam API 25 MG, 50 MG EP

PA 14 29010 3-Amino-6-nitro-4-phenylquinolin-2(1H)-one IMP A 25 MG, 50 MG EP

PA 14 29020 (2-Amino-5-nitrophenyl)phenylmethanone (2-Amino-5-nitrobenzophenone)


PA 14 29510 7-Aminonitrazepam IH 25 MG, 50 MG IH

PA 14 30000 Nitrendipine API 25 MG, 50 MG EP

PA 14 30010 Ethyl Methyl 2 6-Dimethyl-4-(3-nitrophenyl)pyridine-3 5- Imp A 25 MG 50 MG EPPA 14 30010 Ethyl Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate (Photolysis Product)


PA 14 30020 Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


PA 14 30030 Diethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


PA 14 30510 1 4 Dih d 2 6 di th l 4 (3 it h l) idi 3 5 IH IHPA 14 30510 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylic AcidMethyl Ester

IH 25 MG, 50 MG IH

PA 14 30520 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic Acid Ethyl Ester

IH 25 MG, 50 MG IH

PA 14 31000 Nitrofural API 25 MG, 50 MG EP

PA 14 32000 Nitrofurantoin API 25 MG, 50 MG EP

PA 14 33000 Nonivamide API 25 MG, 50 MG EP

PA 14 33510 4-(Aminomethyl)-2-methoxyphenol Hydrochloride (Vanillylamine Hydrochloride)

IH 25 MG, 50 MG IH

PA 14 33520 N-[(4-Hydroxy-3-methoxyphenyl)methyl]-octanamide (N-Vanillyloctanamide

IH 25 MG, 50 MG IH

PA 14 33530 N-[(4-Hydroxy-3-methoxyphenyl)methyl]-decanamide (N-Vanillyldecanamide

IH 25 MG, 50 MG IHVanillyldecanamide

PA 14 34000 Noradrenaline Tartrate API 25 MG, 50 MG EP

PA 14 34010 Adrenaline (L-Adrenaline) Imp. A 25 MG, 50 MG EP

PA 14 34030 Dopamine Hydrochloride Imp. C 25 MG, 50 MG EP

PA 14 35000 Norethisterone API 25 MG, 50 MG EP

PA 14 36000 Norethisterone Acetate API 25 MG, 50 MG EP

PA 14 36010 Norethisterone IMP A 25 MG, 50 MG EP

PA 14 37000 Norfloxacin API 25 MG, 50 MG EP

PA 14 37010 7-Chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid


PA 14 37040 1-Ethyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one Imp. D 25 MG, 50 MG EP

PA 14 37070 1-Ethyl-6-fluoro-7-(4-formylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid


PA 14 38000 Nortriptyline Hydrochloride API 25 MG, 50 MG EP

PA 14 38010 10,11-Dihydro-5H-dibenzo-[a,d][7]annulen-5-one (Dibenzosuberone)


PA 14 38020 3-(5H-dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1-amine hydrochloride(norcyclobenzaprine)

Imp B 25 MG, 50 MG EPa e yd oc o de( o cyc obe ap e)

PA 14 38030 10,11-Dihydro-5-[3-(methyl-amino)propylidene]-5H-dibenzo[a,d][7]-annulen-10-ol


PA 14 38040 3-(5H Dibenzo[a,d][7]annulen-5-ylidene)-N,N -dimethylpropan-1-amine Hydrochloride (Cyclobenzaprine Hydrochloride)


y )

PA 14 38060 Amitriptyline Hydrochloride IMP F 25 MG, 50 MG EP

PA 14 39000 Nebivolol API 25 MG, 50 MG EP

PA 14 39510 Nebivolol N-Benzylated IH 25 MG, 50 MG IHPA 14 39510 Nebivolol N Benzylated IH 25 MG, 50 MG IH

PA 14 40000 Nifuratel API 25 MG, 50 MG EP

PA 14 40510 5-Nitrofuraldazine IH 25 MG, 50 MG IH

PA 14 40520 5-Nitro-2-furaldehyde diacetate IH 25 MG, 50 MG IH

PA 14 41000 Nizatidine API 25 MG, 50 MG IH

PA 14 41010 N,N'-Dimethyl-2-nitroethene-1,1-diamine Imp A 25 MG, 50 MG EP,

PA 14 41020 (EZ)-1-Methylamino-1-methylthio-2-nitroethene Imp B 25 MG, 50 MG EP

PA 14 41030 Nizatidine S-oxide Imp C 25 MG, 50 MG EP

PA 14 41040 2-[(N,N-Dimethylamino)methyl]-4-[(2-aminoethyl)thiomethyl] thiazole


PA 14 41040 Nizatidine HCl Salt 2-[(N,N-Dimethylamino)methyl]-4-[(2-aminoethyl)thiomethyl] thiazole trihydrochloride


PA 14 41050 N-[2-[[[2-[(Dimethylamino) methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide


PA 14 41060 (EZ) N1 N1' [Thi l 2 4 I F EPPA 14 41060 (EZ)-N1,N1'-[Thiazole-2,4-diylbis(methylenesulphanediylethylene)] bis(N'-methyl-2-nitroethene-1,1-diamine)


PA 14 41070 N,N'-bis[2-[[[2-[(Dimethylamino)methyl]thiazol-4-yl] methyl]sulphanyl]ethyl]-2-nitroethene-1,1-diamine


PA 14 41080 2-(Dimethylamino)thioacetamide Imp H 25 MG, 50 MG EP

PA 14 41090 N-[2-[[[2-[(Dimethylamino) methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-N?-methylurea

imp I 25 MG, 50 MG EP

PA 14 41100 2-[(N,N-Dimethylamino)methyl]-4-(hydroxymethyl) thiazole Imp J 25 MG, 50 MG EP

PA 14 41110 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one oxime Imp K 25 MG, 50 MG EP

PA 14 41510 Nizatidine N-Desmethyl Impurity (" N-Desmethyl Nizatidine ") (EZ)-N-[2-[[[2-[(Methylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl] -N'-methyl-2-nitroethene-1,1-diamine

IH 25 MG, 50 MG IH

diamine

PA 14 41520 Nizatidine N-oxide IH 25 MG, 50 MG IH

PA 15 01000 Ofloxacin API 25 MG, 50 MG EP

PA 15 01010 (RS)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H- Imp. A 25 MG, 50 MG EP( ) , y , ypyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (FPA)

p 25 MG, 50 MG

PA 15 01020 (RS)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido-[1,2,3-de]-1,4-benzoxazin-7-one


PA 15 01050 (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-pyrido[1 2 3-de]-1 4-benzoxazine-6-carboxylic

Imp. E 25 MG, 50 MG EPdihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid

PA 15 01060 4-[(RS)-6-Carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-10-yl]-1-methylpiperazine 1-Oxide Hydrochloride (Ofloxacin N-Oxide Hydrochloride


PA 15 02000 Omeprazole API 25 MG, 50 MG EP

PA 15 02010 5-Methoxy-1Hbenzimidazole-2-thiol IMP A 25 MG, 50 MG EP

PA 15 02020 2-[(RS)-[(3,5-Dimethylpyridin- 2-yl)methyl]sulphinyl]-5-methoxy-1H- benzimidazole

IMP. B 25 MG, 50 MG EP

PA 15 02030 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulphanyl]-1H-benzimidazole (Ufiprazole)


PA 15 02040 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphonyl]-1Hbenzimidazole (Omeprazole Sulphone)


PA 15 02050 4-Methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2- Imp. E 25 MG 50 MG EPPA 15 02050 4 Methoxy 2 [[(RS) (5 methoxy 1H benzimidazol 2yl)sulphinyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole N-Oxide


PA 15 02060 8-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol-2(12H)-one


PA 15 02070 9-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a] benzimidazol 2(12H) one

Imp. G 25 MG, 50 MG EPa]-benzimidazol-2(12H)-one

PA 15 02080 2-[(RS)-[(4-Chloro-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole


PA 15 02090 4-Methoxy-2-[[(5-methoxy-1Hbenzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide(Omeprazole Sulphone N-Oxide)


PA 15 02510 5-Methoxy-2-[[(3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole

IH 25 MG, 50 MG IH

PA 15 02520 5-Methoxy-2-[[(4-chloro-3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole

IH 25 MG, 50 MG IH

PA 15 02530 5-Methoxy-1,3-dihydrobenzimidazol-2-one IH 25 MG, 50 MG IHPA 15 02530 5 Methoxy 1,3 dihydrobenzimidazol 2 one IH 25 MG, 50 MG IH

PA 15 02540 2-[[(4-Methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulphinyl]-1H-benzimidazole

IH 25 MG, 50 MG IH

PA 15 03000 Ondansetron Hydrochloride Dihydrate API 25 MG, 50 MG EP

PA 15 03040 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one Imp D 25 MG, 50 MG EP

PA 15 03080 (3RS)-3-[(2-methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (N-demethylondansetron)


PA 15 04000 Ondansetron API 25 MG 50 MG EPPA 15 04000 Ondansetron API 25 MG, 50 MG EP

PA 15 04010 (3RS)-3-(Dimethylamino)-methyl-9-methyl-1,2,3,9-tetrahydro-4Hcarbazol-4-one


PA 15 04030 9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one Imp. C 25 MG, 50 MG EP

PA 15 04040 9 M th l 3 th l 1 2 3 9 t t h d 4H b l 4 I D EPPA 15 04040 9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one Imp. D 25 MG, 50 MG EP

PA 15 04050 1H-Imidazole (Imidazole) IMP E 25 MG, 50 MG EP

PA 15 04060 2-Methyl-1H-imidazole Imp. F 25 MG, 50 MG EP

PA 15 04070 (3RS)-3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4Hcarbazol-4-one (C-Demethylondansetron


PA 15 04080 (3RS)-3-[(2-Methyl-1Himidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (N-Demethylondansetron


PA 15 05000 Opipramol Dihydrochloride API 25 MG, 50 MG EP

PA 15 05510 5-(3-Piperazin-1-yl-propyl)-5H-dibenzo[b,f]azepine Dihydrochloride

IH 25 MG, 50 MG IH

PA 15 06000 Ornidazole API 25 MG, 50 MG EP

PA 15 07000 Orphenadrine Hydrochloride API 25 MG, 50 MG EP

PA 15 07010 (RS)-(2-Methylphenyl)phenylmethanol (2-Methylbenzhydrol Imp. A 25 MG, 50 MG EP

PA 1 0 020 (2 M h l h l) h l h (2 M h lb h ) IMP B EPPA 15 07020 (2-Methylphenyl)phenylmethanone (2-Methylbenzophenone) IMP B 25 MG, 50 MG EP

PA 15 07030 (RS)-2-[(2-Methyl- phenyl)phenylmethoxy]ethanamine Hydrochloride

IMP. C 25 MG, 50 MG EP

PA 15 07040 DiphenhydramineHydrochloride Imp. D 25 MG, 50 MG EP

PA 15 07050 (RS)-N,N-Dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamineHydrochloride (meta-Methylbenzyl Isomer Hydrochloride)


PA 15 07060 (RS)-N,N-Dimethyl-2-[(4-methylphenyl)phenylmethoxy]ethanamineHydrochloride (para-Methylbenzyl Isomer Hydrochloride4-


(p y y yMethyldiphenhydramine Hydrochloride

PA 15 07510 N-Desmethylorphenadrine Hydrochloride IH 25 MG, 50 MG IH

PA 15 08000 Oxacillin Sodium API 25 MG, 50 MG EP

PA 15 08050 Cl illi S di M h d t I E EPPA 15 08050 Cloxacillin Sodium Monohydrate Imp. E 25 MG, 50 MG EP

PA 15 09000 Oxalic Acid Dihydrate API 25 MG, 50 MG EP

PA 15 09510 Oxalic Acid IH 25 MG, 50 MG IH

PA 15 09010 Oxalic Acid Dihydrate IMP A 25 MG, 50 MG EP

PA 15 09510 Oxazepam IH 25 MG, 50 MG IH

PA 15 09040 (2 Amino 5 chlorophenyl) phenylmethanone (2 Amino 5 IMP D 25 MG 50 MG EPPA 15 09040 (2-Amino-5-chlorophenyl) phenylmethanone (2-Amino-5-chlorobenzophenone)


PA 15 10000 Oxcarbazepine API 25 MG, 50 MG EP

PA 15 10510 10-Hydroxy-10,11-dihydrocarbamazepine IH 25 MG, 50 MG IH

PA 15 11000 Oxeladin Hydrogen Citrate API 25 MG, 50 MG EP

PA 15 11010 2-[2-(Diethylamino)ethoxy]ethanol Imp. A 25 MG, 50 MG EP

PA 15 11510 Oxeladin N-Oxide IH 25 MG 50 MG EPPA 15 11510 Oxeladin N-Oxide IH 25 MG, 50 MG EP

PA 15 12000 Oxfendazole API 25 MG, 50 MG EP

PA 15 12020 Methyl [5-(Phenylsulphonyl)-1H-benzimidazol-2-yl]carbamate (Fenbendazole Sulphone)


PA 15 13000 Oxolinic Acid API 25 MG, 50 MG EP

PA 15 14000 Oxybuprocaine Hydrochloride API 25 MG, 50 MG EP

PA 15 14010 4-Aminobenzoic Acid IMP A 25 MG, 50 MG EP25 MG, 50 MG

PA 15 14020 4-Amino-3-butoxybenzoic Acid Imp. B 25 MG, 50 MG EP

PA 15 14030 4-Amino-3-hydroxybenzoic Acid IMP C 25 MG, 50 MG EP

PA 15 15000 Oxybutynin Hydrochloride API 25 MG, 50 MG EP

PA 15 16000 Oxycodone Hydrochloride API 25 MG, 50 MG EP

PA 15 17000 Oxytetracycline Hydrochloride API 25 MG, 50 MG EP

PA 15 17020 Tetracycline Hydrochloride IMP B 25 MG, 50 MG EP

PA 15 18000 Oxymetazoline Hydrochloride API 25 MG, 50 MG EP

PA 15 18010 N (2 Aminoethyl) 2 [4 (1 1 dimethylethyl) 3 hydroxy 2 6 Imp A 25 MG 50 MG EPPA 15 18010 N-(2-Aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide Hydrochloride


PA 15 18020 Xylometazoline Hydrochloride Imp. B 25 MG, 50 MG EP

PA 15 18030 2-[4-(1,1-Dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide


PA 15 18040 [4-(1,1-Dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetic Acid


PA 15 18050 [4-(1,1-Dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetonitrile


PA 15 19000 Olanzapine API 25 MG, 50 MG EPPA 15 19000 Olanzapine API 25 MG, 50 MG EP

PA 15 19010 5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile Imp A 25 MG, 50 MG USP

PA 15 19020 2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one Imp B 25 MG, 50 MG USP

PA 15 19510 Olanzapine Amine Impurity IH 25 MG, 50 MG IH

PA 15 19520 Olanzapine N-Oxide IH 25 MG, 50 MG IH

PA 15 19530 N-Desmethyl Olanzapine IH 25 MG, 50 MG IHy p 25 MG, 50 MG

PA 16 01000 Pantoprazole Sodium Sesquihydrate API 25 MG, 50 MG EP

PA 16 02000 Pantoprazole Sodium API 25 MG, 50 MG EP

PA 16 02010 5 (difl th ) 2 [[(3 4 di th idi I A EPPA 16 02010 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2yl)methyl]sulphonyl]-1H-benzimidazole


PA 16 02020 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2yl)methyl]sulphanyl]-1H-benzimidazole


PA 16 03000 Pantoprazole API 25 MG, 50 MG EP

PA 16 03010 5-(Difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulphonyl]-1H-benzimidazole (Pantoprazole Sulphone


PA 16 03020 5-(Difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole


PA 16 03030 5-(Difluoromethoxy)-1Hbenzimidazole-2-thiol IMP C 25 MG, 50 MG EP

PA 16 03510 2-Chloromethyl-3,4-dimethoxypyridine Hydrochloride IH 25 MG, 50 MG IH

PA 16 03520 Pantoprazole N-Oxide IH 25 MG, 50 MG IH

PA 16 03530 Pantoprazole Sulphone N-Oxide IH 25 MG, 50 MG IH

PA 16 04000 Paroxetine Hydrochloride (anhydrous) API 25 MG, 50 MG EP

PA 16 04010 (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-phenylpiperidine hydrochloride (desfluroparoxetine)


PA 16 04020 1,3-Benzodioxol-5-ol (Sesamol) IMP B 25 MG, 50 MG EP

PA 16 04030 (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine hydrochloride (N-benzyl paroxetine)

Imp C 25 MG, 50 MG EPfluorophenyl)piperidine hydrochloride (N-benzyl paroxetine)

PA 16 04060 (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-phenylpiperidine hydrochloride (N-benzyl desfluoro paroxetine)


PA 16 04070 4-(4-Fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride


PA 16 05000 Paracetamol API 25 MG, 50 MG EP

PA 16 05010 N-(2-Hydroxyphenyl)- acetamide (2-Acetamidophenol) IMP. A 25 MG, 50 MG EP

PA 16 05020 N-(4-Hydroxyphenyl)-propanamide (N-Propionyl-4-aminophenol)


PA 16 05030 (N P i l 4 i h l) I C EPPA 16 05030 (N-Propionyl-4-aminophenol) Imp. C 25 MG, 50 MG EP

PA 16 05040 N-Phenylacetamide (Acetanilide) Imp. D 25 MG, 50 MG EP

PA 16 05050 1-(4-Hydroxyphenyl)ethanone (4-Hydroxyacetophenone) Imp. E 25 MG, 50 MG EP

PA 16 05060 4-Nitrophenol Imp. F 25 MG, 50 MG EP

PA 16 05070 1-(4-Hydroxyphenyl)ethanone Oxime (4-Hydroxyacetophenone Oxime)


PA 16 05080 4 (Acetylamino)phenyl Acetate(N O Diacetyl 4 Imp H 25 MG 50 MG EPPA 16 05080 4-(Acetylamino)phenyl Acetate(N,O-Diacetyl-4-aminophenol)


PA 16 05090 1-(2-Hydroxyphenyl)ethanone (2-Hydroxyacetophenone) Imp. I 25 MG, 50 MG EP

PA 16 05100 N-(4-Chlorophenyl)acetamide (4-Chloroacetanilide) Imp. J 25 MG, 50 MG EP

PA 16 05110 4-Aminophenol Imp. K 25 MG, 50 MG EP

PA 16 05510 3-Aminophenol IH 25 MG, 50 MG IH

PA 16 63520 4-Aminophenol IH 25 MG 50 MG IHPA 16 63520 4-Aminophenol IH 25 MG, 50 MG IH

PA 16 07000 Pentetrazol API 25 MG, 50 MG EP

PA 16 08000 Pentoxifylline API 25 MG, 50 MG EP

PA 16 08010 Theobromine IMP A 25 MG, 50 MG EP

PA 16 08020 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine) IMP B 25 MG, 50 MG EP

PA 16 08030 Theophylline IMP C 25 MG, 50 MG EPp y 25 MG, 50 MG

PA 16 08060 Caffeine IMP F 25 MG, 50 MG EP

PA 16 08510 (+)-(R )-Pulegone IH 25 MG, 50 MG IH

PA 16 09000 Perazine Dimalonate API 25 MG, 50 MG EP

PA 16 09510 Perazine Sulphoxide IH 25 MG, 50 MG IH

PA 16 09520 1-(3-Chloropropyl)-4-methylpiperazine IH 25 MG, 50 MG IH

PA 16 09530 Phenothiazine IH 25 MG, 50 MG IH

PA 16 10000 Perphenazine API 25 MG, 50 MG EP

PA 16 11000 Phenacetin API 25 MG 50 MG EPPA 16 11000 Phenacetin API 25 MG, 50 MG EP

PA 16 12000 Phenethyl Alcohol API 25 MG, 50 MG EP

PA 16 13000 Pheniramine Maleate API 25 MG, 50 MG EP

PA 16 13010 2-Benzylpyridine IMP A 25 MG, 50 MG EP

PA 16 13020 4-Benzylpyridine IMP B 25 MG, 50 MG EP

PA 16 13030 as : (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-4-yl)propan-1- Imp. C 25 MG 50 MG EPPA 16 13030 as : (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-4-yl)propan-1-amine


PA 16 13040 N,N,N',N'- Tetramethyl-3-phenyl-3-(pyridin-2-yl)pentane-1,5-diamine Dihydrochloride Pheniramine


PA 16 13510 Pheniramine N-Oxide Dihydrochlorid IH 25 MG, 50 MG IH

PA 16 13520 Norpheniramine Maleate IH 25 MG, 50 MG IH

PA 16 14000 Phenobarbital API 25 MG, 50 MG EP

PA 16 15000 Phenoxyethanol API 25 MG, 50 MG EPy 25 MG, 50 MG

PA 16 16000 Phenoxymethylpenicillin Potassium API 25 MG, 50 MG EP

PA 16 16010 Benzylpenicillin Potassium IMP A 25 MG, 50 MG EP

PA 16 16020 Ph ti A id IMP B EPPA 16 16020 Phenoxyacetic Acid IMP B 25 MG, 50 MG EP

PA 16 16030 (2S,5R,6R)-6-Amino-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)


PA 16 16040 (2S,5R,6R)-3,3-Dimethyl-7-oxo- 6-[[2-(4- IMP D 25 MG, 50 MG EPhydroxyphenoxy)acetyl]amino]-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (4-Hydroxyphenoxymethylpenicillin)

,

PA 16 17000 Phenylbutazone API 25 MG, 50 MG EP

PA 16 17030 1,2-Diphenyldiazane IMP C 25 MG, 50 MG EP

PA 16 17050 Biphenyl-4,4'-diamine Dihydrochloride (Benzidine Dihydrochloride)


PA 16 18000 (Benzidine Dihydrochloride) API 25 MG, 50 MG EP

PA 16 18030 1-(3-Hydroxy- phenyl)-2-(methylamino)ethanone Hydrochloride (Phenylephrone Hydrochloride)


PA 16 18050 2-(Benzyl- methylamino)-1-(3-hydroxyphenyl)ethanone Hydrochloride (Benzylphenylephrone Hydrochloride)

IMP. E 25 MG, 50 MG EP

PA 16 19000 Phenylpropanolamine Hydrochloride API 25 MG 50 MG EPPA 16 19000 Phenylpropanolamine Hydrochloride API 25 MG, 50 MG EP

PA 16 20000 Phenyltoloxamine Citrate API 25 MG, 50 MG EP

PA 16 21000 Phenytoin API 25 MG, 50 MG EP

PA 16 21010 Diphenylmethanone (Benzophenone) IMP A 25 MG, 50 MG EP

PA 16 21020 Diphenylethanedione (Benzil) IMP B 25 MG, 50 MG EP

PA 16 21030 Amino(diphenyl)acetic Acid (2,2-Diphenylglycine) IMP C 25 MG, 50 MG EPPA 16 21030 Amino(diphenyl)acetic Acid (2,2 Diphenylglycine) IMP C 25 MG, 50 MG EP

PA 16 22000 Phenytoin Sodium API 25 MG, 50 MG EP

PA 16 22010 Diphenylmethanone (Benzophenone) IMP A 25 MG, 50 MG EP

PA 16 22020 Di h l th di (B il) IMP B EPPA 16 22020 Diphenylethanedione (Benzil) IMP B 25 MG, 50 MG EP

PA 16 22030 Amino(diphenyl)acetic Acid (2,2-Diphenylglycine) IMP C 25 MG, 50 MG EP

PA 16 23000 Pilocarpine Hydrochloride API 25 MG, 50 MG EP

PA 16 23020 (2S,3R)-2-Ethyl-3- (hydroxymethyl)-4-(1-methyl-1H-imidazol-5- yl)butanoic Acid Sodium Salt (Pilocarpic Acid Sodium Salt)


PA 16 24000 Pindolol API 25 MG, 50 MG EP

PA 16 24020 1 [4 [2 Hydroxy 3 [(1 methyl ethyl)amino]propoxy] 1H indol IMP B 25 MG 50 MG EPPA 16 24020 1-[4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-1H-indol-1-yl]-3-[(1- methylethyl)amino]propan-2-ol


PA 16 24030 1,1'-[(1-Methylethyl)imino]bis[3- (1H-indol-4-yloxy)propan-2-ol]


PA 16 24040 (2RS)-3-(1H-Indol-4-yloxy)propane- 1,2-diol IMP. D 25 MG, 50 MG EP

PA 16 24050 1H-Indol-4-ol IMP E 25 MG, 50 MG EP

PA 16 24060 (2RS)-1-chloro-3-(1H-indol-4-yloxy)propan-2-ol Imp F 25 MG, 50 MG EP

PA 16 25000 Pipazetate Hydrochloride API 25 MG 50 MG EPPA 16 25000 Pipazetate Hydrochloride API 25 MG, 50 MG EP

PA 16 25510 Bis-(2-piperidinoethyl)ether Dihydrochloride (BPEE Dihydrochloride)

IH 25 MG, 50 MG IH

PA 16 25520 1,2-Dipiperidinoethane (DPE) IH 25 MG, 50 MG IH

PA 16 25530 2-(2-Piperidinoethoxy)ethanol Hydrochloride IH 25 MG, 50 MG IH

PA 16 25540 Pipenzolate Bromide IH 25 MG, 50 MG IH

PA 16 25550 Diphenylmethanone (Benzophenone) IH 25 MG, 50 MG IHp y ( p ) 25 MG, 50 MG

PA 16 25560 Benzilic Acid IH 25 MG, 50 MG IH

PA 16 26000 Piperacillin API 25 MG, 50 MG EP

PA 16 26010 A i illi S di IMP A EPPA 16 26010 Ampicillin Sodium IMP A 25 MG, 50 MG EP

PA 16 26080 (2S,5R,6R)-6-Amino-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)

IMP. H 25 MG, 50 MG EP

PA 16 27000 Piprinhydrinate API 25 MG, 50 MG EP

PA 16 27510 Diphenylpyraline IH 25 MG, 50 MG IH

PA 16 27520 8-Chlorotheophylline IH 25 MG, 50 MG IH

PA 16 27530 Diphenylmethanol (Benzhydrol) IH 25 MG 50 MG IHPA 16 27530 Diphenylmethanol (Benzhydrol) IH 25 MG, 50 MG IH

PA 16 28000 Piracetam API 25 MG, 50 MG EP

PA 16 28010 Pyrrolidin-2-one (2-Pyrrolidone) IMP A 25 MG, 50 MG EP

PA 16 28020 Methyl (2-Oxopyrrolidin-1-yl)acetate IMP B 25 MG, 50 MG EP

PA 16 28030 Ethyl (2-Oxopyrrolidin-1-yl)acetate IMP C 25 MG, 50 MG EP

PA 16 28040 (2-Oxopyrrolidin-1-yl)acetic Acid IMP D 25 MG 50 MG EPPA 16 28040 (2-Oxopyrrolidin-1-yl)acetic Acid IMP D 25 MG, 50 MG EP

PA 16 28510 N-Vinyl-2-pyrrolidone IH 25 MG, 50 MG IH

PA 16 28520 2-Chloroacetamide IH 25 MG, 50 MG IH

PA 16 29000 Piroxicam API 25 MG, 50 MG EP

PA 16 29010 Pyridin-2-amine (2-Pyridylamine) IMP A 25 MG, 50 MG EP

PA 16 29020 4-Hydroxy-N-(pyridin-2- yl)-2H-1,2-benzothiazine-3- IMP B 25 MG, 50 MG EPy y (py y ) ,carboxamide 1,1-Dioxide

25 MG, 50 MG

PA 16 29030 4-Hydroxy-2-methyl-2H- 1,2-benzothiazine-3-carboxamide 1,1-Dioxide


PA 16 29040 Methyl (1,1-Dioxido-3-oxo- 1,2-benzisothiazol-2(3H)-yl)acetate


PA 16 29050 Eth l (1 1 Di id 3 1 2 b i thi l 2(3H) IMP E EPPA 16 29050 Ethyl (1,1-Dioxido-3-oxo- 1,2-benzisothiazol-2(3H)-yl)acetate


PA 16 29060 1-Methylethyl (1,1-Dioxido-3- oxo-1,2-benzisothiazol-2(3H)-yl)acetate


PA 16 29070 Methyl 4-Hydroxy-2H-1,2- benzothiazine-3-carboxylate 1,1-Dioxide

IMP G 25 MG, 50 MG EPo de

PA 16 29080 Ethyl 4-Hydroxy-2H-1,2- benzothiazine-3-carboxylate 1,1-Dioxide


PA 16 29100 Methyl 4-Hydroxy-2- methyl-2H-1,2-benzothiazine-3- carboxylate 1,1-Dioxide


PA 16 29110 Ethyl 4 Hydroxy 2 methyl 2H 1 2 benzothiazine 3 IMP K 25 MG 50 MG EPPA 16 29110 Ethyl 4-Hydroxy-2-methyl- 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide


PA 16 29120 1-methylethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide

Imp L 25 MG, 50 MG EP

PA 16 29510 N-Methylsaccharin IH 25 MG, 50 MG IH

PA 16 29520 4-Methoxy-2-methyl-N-(2-pyridyl)-2H- 1,2-benzothiazine-3-carboxamide 1,1-Dioxide

IH 25 MG, 50 MG IH

PA 16 30000 Potassium Sorbate API 25 MG, 50 MG EP

PA 16 31000 Povidone API 25 MG 50 MG EPPA 16 31000 Povidone API 25 MG, 50 MG EP

PA 16 31010 1-Ethenylpyrrolidin-2-one (1-Vinylpyrrolidin-2-one,N-Vinyl-2-pyrrolidone)


PA 16 31020 Pyrrolidin-2-one (2-Pyrrolidone) IMP B 25 MG, 50 MG EP

PA 16 31510 Vinyl acetate IH 25 MG, 50 MG IH

PA 16 32000 Prasterone API 25 MG, 50 MG EP

PA 16 32510 Pravastatin Sodium IH 25 MG, 50 MG IH25 MG, 50 MG

PA 16 32040 (1S,3S,7S,8S,8aR)-3-Hydroxy-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Pravastatin Lactone)


PA 16 33000 Prazepam API 25 MG, 50 MG EP

PA 16 33010 7 Chl 5 h l 1 3 dih d 2H 1 4 b di i 2 I A EPPA 16 33010 7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one (Nordazepam)[Controlled Substance


PA 16 33030 (2-Amino-5-chlorophenyl)phenylmethanone Imp. C 25 MG, 50 MG EP

PA 16 34000 Praziquantel API 25 MG, 50 MG EP

PA 16 34020 2-(Cyclohexylcarbonyl)- 2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]- isoquinolin-4-one


PA 16 35000 Prazosin Hydrochloride API 25 MG, 50 MG EP

PA 16 35010 2 Chloro 6 7 dimethoxyquinazolin 4 amine Imp A 25 MG 50 MG EPPA 16 35010 2-Chloro-6,7-dimethoxyquinazolin-4-amine Imp. A 25 MG, 50 MG EP

PA 16 35020 1,4-Bis(furan-2-ylcarbonyl)- piperazine IMP B 25 MG, 50 MG EP

PA 16 35030 6,7-Dimethoxy-2- (piperazin-1-yl)quinazolin-4-amine IMP C 25 MG, 50 MG EP

PA 16 35040 1-(Furan-2-ylcarbonyl)-piperazine Imp. D 25 MG, 50 MG EP

PA 16 35050 2,2'-(Piperazin-1,4-diyl)bis- (6,7-dimethoxyquinazolin-4-amine)


PA 16 35510 2,4-Dichloro-6,7-dimethoxyquinazoline IH 25 MG 50 MG IHPA 16 35510 2,4-Dichloro-6,7-dimethoxyquinazoline IH 25 MG, 50 MG IH

PA 16 35520 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione IH 25 MG, 50 MG IH

PA 16 36000 Prednisolone API 25 MG, 50 MG EP

PA 16 36010 Hydrocortisone Imp. A 25 MG, 50 MG EP

PA 16 36020 17,21-Dihydroxypregna- 1,4-diene-3,11,20-trione (Prednisone)


PA 16 36030 11β,17-Dihydroxy-3,20- dioxopregna-1,4-dien-21-yl Acetate IMP C 25 MG, 50 MG EPβ, y y , p g , y(Prednisolone Acetate)

25 MG, 50 MG

PA 16 37000 Prednisolone Acetate API 25 MG, 50 MG EP

PA 16 37010 Hydrocortisone Acetate Imp. A 25 MG, 50 MG EP

PA 16 37020 P d i l I B EPPA 16 37020 Prednisolone Imp. B 25 MG, 50 MG EP

PA 16 37510 Prednisone Acetate IH 25 MG, 50 MG IH

PA 16 38000 Prednisone API 25 MG, 50 MG EP

PA 16 39000 PrilocaineHydrochloride API 25 MG, 50 MG EP

PA 16 39010 (RS)-2-Chloro-N-(2-methylphenyl)- propanamide IMP A 25 MG, 50 MG EP

PA 16 39020 2 Methylbenzenamine (o Toluidine) Imp B 25 MG 50 MG EPPA 16 39020 2-Methylbenzenamine (o-Toluidine) Imp. B 25 MG, 50 MG EP

PA 16 39030 (RS)-2-Ethylamino- N-(2-methylphenyl)propanamide Hydrochloride


PA 16 39040 (RS)-N-(3-Methyl- phenyl)-2-(propylamino)propanamide Hydrochloride


PA 16 39050 (RS)-N-(4-Methyl- phenyl)-2-(propylamino)propanamide Hydrochloride


PA 16 40000 Primidone API 25 MG, 50 MG EP

PA 16 40030 (2RS)-2-Phenylbutanamide Imp. C 25 MG 50 MG EPPA 16 40030 (2RS)-2-Phenylbutanamide Imp. C 25 MG, 50 MG EP

PA 16 40050 (2RS)-2-Phenylbutanoic Acid Imp. E 25 MG, 50 MG EP

PA 16 41000 Probenecid API 25 MG, 50 MG EP

PA 16 42000 Procainamide Hydrochloride API 25 MG, 50 MG EP

PA 16 42510 Procainamide N-Oxide Dihydrochloride IH 25 MG, 50 MG IH

PA 16 43000 Procaine Hydrochloride API 25 MG, 50 MG EPy 25 MG, 50 MG

PA 16 43510 4-Aminobenzoic Acid IH 25 MG, 50 MG EP

PA 16 43520 Progesterone IH 25 MG, 50 MG EP

PA 16 43530 11 H d t IH EPPA 16 43530 11a-Hydroxyprogesterone IH 25 MG, 50 MG EP

PA 16 43540 11-Ketoprogesterone IH 25 MG, 50 MG EP

PA 16 44000 Promazine Hydrochloride API 25 MG, 50 MG EP

PA 16 44010 3-(10H-Phenothiazin-10-yl)- N,N-dimethylpropan-1-amine S-Oxide (Promazine Sulphoxide)


PA 16 44510 N,N-Dimethyl-3-chloropropylamine Hydrochloride IH 25 MG, 50 MG IH

PA 16 44520 Phenothiazine IH 25 MG 50 MG IHPA 16 44520 Phenothiazine IH 25 MG, 50 MG IH

PA 16 45000 Promethazine Hydrochloride API 25 MG, 50 MG EP

PA 16 45010 Phenothiazine Imp. A 25 MG, 50 MG EP

PA 16 45020 (2RS)-N,N-dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine (isopromethazine)

Imp B 25 MG, 50 MG

PA 16 45030 (2RS)-N-methyl-1-(10H-phenothiazin-10-yl)-propan-2-amine Imp C 25 MG, 50 MG

PA 16 45040 (2RS)-N,N-Dimethyl-1-(10H- phenothiazin-10-yl) IMP D 25 MG 50 MG EPPA 16 45040 (2RS)-N,N-Dimethyl-1-(10H- phenothiazin-10-yl)propan-2-amine S-Oxide (Promethazine Sulphoxide)


PA 16 45510 (2RS)-N-Methyl-2-(10H-phenothiazin-10- yl)propan-1-amine Hydrochloride (Noriso- promethazine Hydrochloride)

IH 25 MG, 50 MG IH

PA 16 46000 Propafenone Hydrochloride API 25 MG, 50 MG EP

PA 16 46010 1-(2-Hydroxyphenyl)-3- phenylpropan-1-one IMP A 25 MG, 50 MG EP

PA 16 46030 1-[2-[[(2RS)-Oxiranyl]methoxy]- phenyl]-3-phenylpropan-1-on IMP C 25 MG, 50 MG EP

PA 16 47000 Propofol API 25 MG 50 MG EPPA 16 47000 Propofol API 25 MG, 50 MG EP

PA 16 47050 3,3',5,5'-Tetrakis(1- methylethyl)biphenyl-4,4'-diol IMP E 25 MG, 50 MG EP

PA 16 47060 3-(1-Methylethyl)phenol Imp. F 25 MG, 50 MG EP

PA 16 47070 2 (1 M th l th ) 1 3 bi (1 th l th l)b IMP G EPPA 16 47070 2-(1-Methylethoxy)-1,3- bis(1-methylethyl)benzene IMP G 25 MG, 50 MG EP

PA 16 47080 4-(1-Methylethyl)phenol Imp. H 25 MG, 50 MG EP

PA 16 47090 Oxydibenzene IMP I 25 MG, 50 MG EP

PA 16 47110 1-(1-Methylethoxy)-2-(1- methylethyl)benzene IMP K 25 MG, 50 MG EP

PA 16 48000 Propranolol Hydrochloride API 25 MG, 50 MG EP

PA 16 48010 (2RS) 3 (Naphthalen 1 yloxy)propane 1 2 diol (Diol IMP A 25 MG 50 MG EPPA 16 48010 (2RS)-3-(Naphthalen-1- yloxy)propane-1,2-diol (Diol Derivative)


PA 16 48020 1,1'-[(1- Methylethyl)imino]bis[3-(naphthalen-1- yloxy)propan-2-ol] Hydrochloride (Tertiary Amine Derivative Hydrochloride)


PA 16 48030 1,3-bis(naphthalen-1-yloxy)-propan-2-ol (bis-ether d i ti )

Imp C 25 MG, 50 MG EPderivative)

PA 16 48510 1-Naphthol IH 25 MG, 50 MG IH

PA 16 48520 1-(1-Naphthyloxy)-2,3-epoxypropane IH 25 MG, 50 MG IH

PA 16 49000 Propyl Gallate API 25 MG, 50 MG EP

PA 16 50000 Propyl Parahydroxybenzoate API 25 MG, 50 MG EP

PA 16 50010 4-Hydroxybenzoic Acid Imp. A 25 MG, 50 MG EP

PA 16 50020 Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate) IMP B 25 MG, 50 MG EP

PA 16 50030 Ethyl 4-Hydroxybenzoate(Ethyl Parahydroxybenzoate) Imp. C 25 MG, 50 MG EP

PA 16 50040 Butyl 4-Hydroxybenzoate(Butyl Parahydroxybenzoate Imp. D 25 MG, 50 MG EP

PA 16 50510 Sodium Propyl Parahydroxybenzoate IH 25 MG, 50 MG IH

PA 16 51000 Proxymetacaine Hydrochloride API 25 MG, 50 MG EP

PA 16 51510 P t i N O id Dih d hl id IH IHPA 16 51510 Proxymetacaine N-Oxide Dihydrochloride IH 25 MG, 50 MG IH

PA 16 52000 Proxyphylline API 25 MG, 50 MG EP

PA 16 53000 (+)-Pseudoephedrine Hydrochloride API 25 MG, 50 MG EP

PA 16 53510 Methcathinone Hydrochloride (2-Methylamino-1-phenylpropan-1-one Hydrochloride)

IH 25 MG, 50 MG IH

PA 16 53520 (1S,2S)-N-Acetylpseudoephedrine IH 25 MG, 50 MG IH

PA 16 53530 (1S 2S) N O Diacetylpseudoephedrine IH 25 MG 50 MG IHPA 16 53530 (1S,2S)-N,O-Diacetylpseudoephedrine IH 25 MG, 50 MG IH

PA 16 54000 Pyrazinamide API 25 MG, 50 MG EP

PA 16 54010 Pyrazine-2-carboxylic Acid IMP A 25 MG, 50 MG EP

PA 16 55000 Pyridoxine Hydrochloride API 25 MG, 50 MG EP

PA 16 56000 Paliperidone API 25 MG, 50 MG EP

PA 16 56510 Paliperidone Chloro Impurity IH 25 MG, 50 MG IH

3-(2-Chloroethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-(1,2-a)-pyrimidin-4-one

PA 16 56520 Paliperidone Amine Impurity

6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride

IH 25 MG, 50 MG IH

PA 16 56530 Paliperidone N-Oxide IH 25 MG 50 MG IHPA 16 56530 Paliperidone N-Oxide IH 25 MG, 50 MG IH

PA 16 56540 Paliperidone 9-Keto Impurity IH 25 MG, 50 MG IH

PA 16 56550 Paliperidone 5-Fluoro Isomer IH 25 MG, 50 MG IH

PA 16 57000 Paroxetine API 25 MG, 50 MG EP

PA 16 57510 Paroxetine HCl IH 25 MG, 50 MG IH

PA 16 57520 Paroxetine HCl Hemihydrate IH 25 MG, 50 MG IH

PA 16 57530 P ti F t IH IHPA 16 57530 Paroxetine Formate IH 25 MG, 50 MG IH

PA 16 57540 Paroxetine Acetate IH 25 MG, 50 MG IH

PA 16 57550 : Paroxetine Sulfate IH 25 MG, 50 MG IH

PA 16 57560 Paroxetine Phosphate IH 25 MG, 50 MG IH

PA 16 57570 Paroxetine Maleate IH 25 MG, 50 MG IH

PA 16 57010 (3S 4R) trans 4 (p Methoxyphenyl) 3 [(3 4 Imp A 25 MG 50 MG USPPA 16 57010 (3S,4R)-trans-4-(p-Methoxyphenyl)-3-[(3,4-methylenedioxy)phenoxy]methylpiperidine hydrochloride (" 4-Methoxy Paroxetine Hydrochloride ")


PA 16 57010 (3S,4R)-trans-4-Phenyl-3-[(3,4-methylenedioxy)phenoxy]methylpiperidine (" Desfluoro Paroxetine ")


PA 16 57020 (3S,4R)-trans-4-Phenyl-3-[(3,4- Imp B 25 MG, 50 MG USP( , ) y [( ,methylenedioxy)phenoxy]methylpiperidine acetate (" Desfluoro Paroxetine Acetate ")

p 5 MG, 50 MG

PA 16 57030 (3S,4R)-trans-4-(p-Ethoxyphenyl)-3-[(3,4-methylenedioxy)phenoxy]methylpiperidine hydrochloride (" 4-Ethoxy Paroxetine Hydrochloride ")


PA 16 57040 (3R,4S)-trans-(+)-4-(p-Fluorophenyl)-3-[(3,4- Imp D 25 MG, 50 MG EP( ) ( ) (p p y ) [(methylenedioxy)phenoxy]methylpiperidine hydrochloride

p ,

PA 16 57050 (3R,4R)-trans-4-(p-Fluorophenyl)-3-[(3,4-methylenedioxy)phenoxy]methylpiperidine hydrochloride


PA 16 57070 4-(4-Fluorophenyl)-1-methyl-1,2,3,6-tetrahydro pyridine Imp G 25 MG, 50 MG EP

PA 16 57060 (3S,4R)-trans-(-)-1-Methyl-3-[1,3-benzodioxol-5-yloxy)methyl]-4-(fluorophenyl)piperidine

Imp F 25 MG, 50 MG USP

PA 16 57570 (3R,4S)-N-Methyl Paroxetine IH 25 MG, 50 MG IH

PA 16 57580 (±)-3-Ethoxycarbonyl-4-(4-fluoro phenyl)-1-methylpiperidin-2 6 di ( l d)

IH 25 MG, 50 MG IH2,6-dione (unresolved)

PA 16 57590 (±)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine (unresolved)

IH 25 MG, 50 MG IH

PA 16 57600 (3S,4R)-trans-(-)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine

IH 25 MG, 50 MG IH

PA 16 57610 (3R 4S) t ( ) 4 (4 Fl h l) 3 h d th l 1 IH IHPA 16 57610 (3R,4S)-trans-(+)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine

IH 25 MG, 50 MG IH

PA 16 57620 3R,4R)-cis-(+)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine

IH 25 MG, 50 MG IH

PA 16 57630 (3S,4S)-cis-(-)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine

IH 25 MG, 50 MG IHet y p pe d e

PA 16 57090 (3S,4R)-trans-(-)-4-(4-Fluorophenyl)-3-hydroxymethyl-piperidine

Imp I 25 MG, 50 MG IH

PA 16 57640 (3R,4R)-N-Methyl Paroxetine IH 25 MG, 50 MG IH

PA 16 57060 Bis {3 4 methylenedioxy 6 [(3S 4R) 4 (4 fluorophenyl) Imp F 25 MG 50 MG EPPA 16 57060 Bis {3,4-methylenedioxy-6-[(3S,4R)-4-(4-fluorophenyl) piperidine-3 -ylmethoxy]phenyl} methane


PA 16 57650 : Paroxetine Dimer N-Methyl Impurity IH 25 MG, 50 MG IH

PA 16 57660 Paroxetine 4-Hydroxy Metabolite; 4-HM Paroxetine IH 25 MG, 50 MG IH

PA 16 57670 Paroxetine 3-Hydroxy Metabolite; 3-HM Paroxetine; IH 25 MG, 50 MG IH

PA 16 57020 1,3-Benzodioxol-5-ol (" Sesamol ") Imp B 25 MG, 50 MG EP

PA 16 57030 (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine ("N-Benzyl Paroxetine")


PA 16 57060 (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-1-benzyl-4-phenylpiperidine ("N-Benzyl Desfluoro Paroxetine")


PA 16 57080 Anhydrous Paroxetine EP Impurity H

[(3S,4R)-1-Benzyl-4-(4-fluorophenyl)-piperidin-3-yl]methanol

Imp H 25 MG, 50 MG

PA 16 57100 (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4'- fluorobiphenyl-3-yl)piperidine


PA 16 58000 Pericyazine API 25 MG 50 MG EPPA 16 58000 Pericyazine API 25 MG, 50 MG EP

PA 16 58510 2-Cyanophenothiazine IH 25 MG, 50 MG IH

PA 16 58520 2-Chlorophenothiazine IH 25 MG, 50 MG IH

PA 16 59000 API EPPA 16 59000 Perindopril API 25 MG, 50 MG EP

PA 16 59510 Perindopril t-Butylamine IH 25 MG, 50 MG IH

PA 16 59010 (2S,3aS,7aS)-octahydro-1H-indole-2-carboxylic acid Imp A 25 MG, 50 MG EP

PA 16 59020 (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-carboxybutyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid ("Perindoprilat"; "Perindopril Diacid")


PA 16 59030 (2S)-2-[(3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1 2-a]indol-2(1H)-yl]pentanoic acid

Imp C 25 MG, 50 MG EPdioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]pentanoic acid ("Perindopril (10aS)-Dione Acid")

PA 16 59040 (2S)-2-[(3S,5aS,9aS,10aR)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]pentanoic acid ("Perindopril (10aR)-Dione Acid")


PA 16 59050 (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-[(1-methylethoxy)carbonyl]butyl]amino]propanoyl]octahydro 1H

Imp E 25 MG, 50 MG EPmethylethoxy)carbonyl]butyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid ("Perindopril Isopropyl Analog")

PA 16 59060 ethyl (2S)-2-[(3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]pentanoate ("Perindopril (10aS)-Dione")


PA 16 59520 P i d il Di I l E t IH IHPA 16 59520 Perindopril Dione Isopropyl Ester IH 25 MG, 50 MG IH

PA 16 60000 Pioglitazone HCl API 25 MG, 50 MG EP

PA 16 60010 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-5-hydroxy-2,4-thiazolidinedione ("Pioglitazone 5-Hydroxy Impurity")

Imp A 25 MG, 50 MG EP, ( g y y p y )

PA 16 60020 5-{4-[2-(5-Ethyl-2-pyridinyl) ethoxy] benzylidene}-2,4-thiazolidinedione ("Pioglitazone Benzylidene Impurity")


PA 16 60030 Pioglitazone Imp C 25 MG, 50 MG EP

PA 16 60040 Pioglitazone Imp D 25 MG, 50 MG EP

PA 16 60050 Pioglitazone Imp E 25 MG, 50 MG

PA 16 60510 Pioglitazone Imino Impurity

5-{4-[2-(5-Ethyl-2-pyridinyl) ethoxy] benzyl}-2-imino-4-

IH 25 MG, 50 MG IH

PA 16 60520 Pi lit S lf i I it IH IHPA 16 60520 Pioglitazone Sulfonic Impurity IH 25 MG, 50 MG IH

PA 16 60530 Pioglitazone Fluoro Impurity IH 25 MG, 50 MG IH

PA 16 60540 Pioglitazone Bromo Impurity IH 25 MG, 50 MG IH

2-[2-(4-bromophenoxy) ethyl-5-ethylpyridine PA 16 60550 Pioglitazone Metabolite M1 IH 25 MG, 50 MG IH

PA 16 60560 Pioglitazone Metabolite M2 IH 25 MG, 50 MG IH

PA 16 60570 Pioglitazone Metabolite M3 IH 25 MG 50 MG IHPA 16 60570 Pioglitazone Metabolite M3 IH 25 MG, 50 MG IH

PA 16 60580 Pioglitazone Metabolite M4 IH 25 MG, 50 MG IH

PA 16 60590 Pioglitazone etabolite M5 IH 25 MG, 50 MG IH

PA 16 61000 Pitavastatin (Acid) ("Itavastatin") (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid

API 25 MG, 50 MG EP

PA 16 61510 Pitavastatin Calcium (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-

IH 25 MG, 50 MG IH(3R,5S,6E) 7 [2 cyclopropyl 4 (4 fluorophenyl)quinolin 3 yl]3,5-dihydroxyhept-6-enoic acid calcium salt

PA 16 61520 Pitavastatin Sodium (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid sodium salt

IH 25 MG, 50 MG IH

PA 16 61530 Pitavastatin Lactone (4R,6S,E)-6-[2-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-

IH 25 MG, 50 MG IH( ) [ [ y p py ( p y )qyl]vinyl]tetrahydro-4-hydroxypyran-2-one

PA 16 61540 Pitavastatin Ethyl Ester (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid ethyl ester

IH 25 MG, 50 MG IH

PA 16 61550 Pitavastatin Methyl Ester (3R 5S 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-

IH 25 MG, 50 MG IH(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid methyl ester

PA 16 61560 Pitavastatin t-Butyl Ester (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid t-butyl ester

IH 25 MG, 50 MG IH

PA 16 61570 Pitavastatin Acetonide t-Butyl Ester (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl]-2,2-dimethyl-1,3-dioxane-6-heptenoic acid t-butyl ester

IH 25 MG, 50 MG IH

PA 16 61580 Pitavastatin 3-Oxo Ethyl Ester Ethyl (E)-7-[2-cyclopropyl-4-(4-flurophenyl)-3-quinolinyl]-5-hydroxy-3-oxo-6-heptenoate

IH 25 MG, 50 MG IH

PA 16 61590 Pitavastatin 5-Oxo Ethyl Ester Ethyl (E)-7-[2-cyclopropyl-4-(4-flurophenyl)-3-quinolinyl]-3-hydroxy-5-oxo-6-heptenoate

IH 25 MG, 50 MG IH

PA 16 61600 Pitavastatin 3-Oxo Impurity (E)-7-[2-Cyclopropyl-4-(4-flurophenyl)-3-quinolinyl]-5-hydroxy-3-oxo-6-heptenoic acid

IH 25 MG, 50 MG IH

PA 16 61610 Pitavastatin 5-Oxo Impurity (E)-7-[2-Cyclopropyl-4-(4-flurophenyl)-3-quinolinyl]-3-hydroxy-5-oxo-6-heptenoic acid

IH 25 MG, 50 MG IH

PA 16 62000 Propiverine API 25 MG, 50 MG EP

PA 16 62510 Propiverine Hydrochloride 1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride

IH 25 MG, 50 MG IH

PA 16 62520 Propiverine Chloro Impurity 1-methyl-4-piperidyl diphenyl chloroacetate

IH 25 MG, 50 MG IH1 methyl 4 piperidyl diphenyl chloroacetate

PA 16 62530 Propiverine Hydroxy Impurity 1-methyl-4-piperidyl diphenyl hydroxyacetate

IH 25 MG, 50 MG IH

PA 16 62540 Propiverine N-Oxide IH 25 MG, 50 MG IH

PA 16 62550 N Desmethyl Propiverine IH 25 MG 50 MG IHPA 16 62550 N-Desmethyl Propiverine 4-piperidyl diphenyl propoxyacetate

IH 25 MG, 50 MG IH

PA 17 01000 Quinapril Hydrochloride API 25 MG, 50 MG EP

PA 17 01510 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide) IH 25 MG, 50 MG IH

PA 17 01010 (3S )-1,2,3,4-Tetra-hydroisoquinoline-3-carboxylic Acid IMP A 25 MG, 50 MG EP

PA 17 01020 (2S )-2-[[(1S )-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-propanoic Acid


PA 17 01030 (3S )-2-[(2S )-2-[[(1S )-1-Carboxy-3-phenylpropyl]amino]propanoyl]-1,2,3,4-tetrahydroisoquinoline-3-carboxylic Acid


PA 17 01040 Ethyl (2S )-2-[(3S ,11aS )-3-Methyl-1,4-dioxo-1,3,4,6,11,11a-hexahydro-2H -pyrazino[1,2-b]isoquinolin-2-yl]-4-phenyl-butanoate


PA 17 01060 Benzyl (3S )-2-[(2S )-2-[[(1S )-1-(Ethoxycarbonyl)-3-phenyl]amino]-propanoyl]-1,2,3,4-tetrahydroisoquinoline-3-carboxylate


PA 17 02000 Quinine Dihydrochloride API 25 MG, 50 MG EP

PA 17 02510 Quinuclidinyl Benzilate IH 25 MG, 50 MG IH

PA 17 02520 Benzilic Acid IH 25 MG, 50 MG IH

PA 17 02530 3-Quinuclidinol IH 25 MG, 50 MG IH

PA 17 03000 Quetiapine API 25 MG, 50 MG EP

PA 17 03510 Quetiapine Hemifumarate IH 25 MG, 50 MG IH

PA 17 03520 Norquetiapine IH 25 MG 50 MG IHPA 17 03520 Norquetiapine 11-Piperazin-1-yl-dibenzo[b,f][1,4]thiazepine Dihydrochloride ("DBTP")

IH 25 MG, 50 MG IH

PA 17 03530 Dibenzo[b,f][1,4]thiazepine-11(10-H)-one ("DBTO") [CAS # 3159-07-7]

IH 25 MG, 50 MG IH

PA 17 03540 Quetiapine S-Oxide IH 25 MG, 50 MG IH

PA 17 03550 Quetiapine Sulfone IH 25 MG, 50 MG IH

PA 17 03560 7-Hydroxy-N-des {[2-(2-hydroxy)ethoxy]ethyl} Quetiapine Dihydrochloride

IH 25 MG, 50 MG IH

PA 17 03570 7-Hydroxy Quetiapine IH 25 MG, 50 MG IH

PA 17 03580 : 7-Hydroxy Quetiapine S-Oxide IH 25 MG, 50 MG IH

PA 17 03590 Des-hydroxyethyl Quetiapine IH 25 MG, 50 MG IH

PA 17 03600 Quetiapine N-Oxide IH 25 MG, 50 MG IH

PA 17 03610 1-[2-(2-Hydroxyethoxy)ethyl]piperazine [ CAS # 13349-82-1 ]

IH 25 MG, 50 MG IH

PA 17 03620 Q ti i Di IH IHPA 17 03620 Quetiapine Dimer 11,11'-(1,4-Piperazinediyl)-bis-dibenzo[b,f][1,4]thiazepine

IH 25 MG, 50 MG IH

PA 18 01000 Rabeprazole Sodium API 25 MG, 50 MG EP

PA 18 02000 Rabeprazole API 25 MG, 50 MG EP

PA 18 02510 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]thio]-1H-benzimidazole

IH 25 MG, 50 MG EP

PA 18 02520 Rabeprazole Sulphone IH 25 MG, 50 MG IH

PA 18 02530 Rabeprazole N Oxide IH 25 MG 50 MG IHPA 18 02530 Rabeprazole N-Oxide IH 25 MG, 50 MG IH

PA 18 02540 Rabeprazole Sulphone N-Oxide IH 25 MG, 50 MG IH

PA 18 03000 Raloxifene Hydrochloride API 25 MG, 50 MG EP

PA 18 04000 Ramipril API 25 MG, 50 MG EP

PA 18 04010 Ramipril Methyl Ester Imp A 25 MG, 50 MG EP

PA 18 04020 Ramipril Isopropyl Ester Imp B 25 MG 50 MG EPPA 18 04020 Ramipril Isopropyl Ester Imp B 25 MG, 50 MG EP

PA 18 04030 Hexahydro Ramipril Imp C 25 MG, 50 MG EP

PA 18 04040 Ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3-Methyl-1,4-dioxodecahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl] 4 phenylbutanoate(Ramipril Diketopiperazine)


yl]-4-phenylbutanoate(Ramipril Diketopiperazine)

PA 18 04050 (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic Acid (Ramipril Diacid)


PA 18 04060 (2S )-2-[[(1S )-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-i A id

IMP F 25 MG, 50 MG EPpropanoic Acid

PA 18 04070 Methylbenzene (Toluene) IMP G 25 MG, 50 MG EP

PA 18 05000 Ranitidine Hydrochloride API 25 MG, 50 MG EP

PA 18 05020 2 [[[5 [(di th l i ) th l]f 2 I B EPPA 18 05020 2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethanamine


PA 18 05030 N-[2-[[[5-[(Dimethylamino)-methyl]furan-2-yl]methyl]sulphinyl]ethyl]-N'-methyl-2-nitroethene-1,1-diamine (Ranitidine Sulphoxide)


PA 18 05050 N-[2-[[[5-[(Dimethyloxidoamino)-methyl]furan-2- IMP E 25 MG, 50 MG EP[ [[[ [( y ) y ]yl]methyl]sulphanyl]ethyl]-N'-methyl-2-nitroethene-1,1-diamine (Ranitidine N-Oxide)

,

PA 18 05110 N-Methyl-1-methylthio-2-nitroethenamine ((EZ)-N-Methyl-1-(methylsulphanyl)-2-nitroethen-1-amine)


PA 18 06000 Riboflavin API 25 MG, 50 MG EP

PA 18 07000 Ribavirin API 25 MG, 50 MG EP

PA 18 07030 1H-1,2,4-Triazole-3-carboxylic Acid IMP C 25 MG, 50 MG EP

PA 18 07040 1H-1 2 4-Triazole-3-carboxamide IMP D 25 MG 50 MG EPPA 18 07040 1H-1,2,4-Triazole-3-carboxamide IMP D 25 MG, 50 MG EP

PA 18 08000 Rifampicin API 25 MG, 50 MG EP

PA 18 09000 Risperidone API 25 MG, 50 MG EP

PA 18 09010 3-[2-[4-[(E)-(2,4-Difluorophenyl)-(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]-pyrimidin-4-one


PA 18 09020 3-[2-[4-[(Z)-(2,4-Difluorophenyl)-(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]-pyrimidin-4-one


PA 18 09030 (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2- methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- pyrimidin-4-one (9-Hydroxyrisperidone)


PA 18 09040 3-[2-[4-(5-Fluoro-1,2-benzisoxazol- 3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9- tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one


PA 18 09050 (6RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one


PA 18 09070 3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1- yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido- [1,2-a]pyrimidin-4-one


PA 18 09080 3-[2-[4-(2,4-Difluorobenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one


PA 18 09120 3-(2- Chloroethyl)-2-methyl-6,7,8,9-tetrahydro-4H- pyrido[1,2-a]pyrimidin-4-one Hydrochloride (Risperidone Piperidopyrimidinone Intermediate Hydrochloride)

IMP L 25 MG, 50 MG EP

PA 18 10000 Ritodrine Hydrochloride API 25 MG, 50 MG EP

PA 18 10010 Tyramine IMP A 25 MG, 50 MG EP

PA 18 11000 Ronidazole API 25 MG, 50 MG EP

PA 18 11510 (1-Methyl-5-nitroimidazol-2-yl)methanol IH 25 MG, 50 MG IH

PA 18 12000 Rosiglitazone Maleate API 25 MG, 50 MG EP

PA 18 12510 Rosiglitazone IH 25 MG, 50 MG EP

PA 18 12520 5-{[4-[2-(N-methyl-N-2-pyridinyl) amino] ethoxy benzylidene}-2,4-thiazolidine dione

IH 25 MG, 50 MG IH

PA 18 12530 4-[2-(N-methyl-N-2-pyridinyl)amino]ethoxybenzaldehyde IH 25 MG, 50 MG IH

PA 18 12540 2,4-Thiazolidinedione IH 25 MG, 50 MG IH

PA 18 12550 N-Desmethyl Rosiglitazone IH 25 MG, 50 MG IH

PA 18 13000 R t id T ih d t API EPPA 18 13000 Rutoside Trihydrate API 25 MG, 50 MG EP

PA 18 13030 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one Dihydrate (Quercetin Dihydrate)


PA 18 14000 Rosuvastatin Acid API 25 MG, 50 MG EP

PA 18 14510 Rosuvastatin Calcium(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid calcium salt

IH 25 MG, 50 MG IH

PA 18 14520 Rosuvastatin Sodium(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept 6 enoic acid sodium salt

IH 25 MG, 50 MG IH

hept-6-enoic acid sodium salt

PA 18 14530 Rosuvastatin LactoneN-[4-(4-Fluorophenyl)-6-(1-methylethyl)-5-[(1E)-2-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethenyl]-2-pyrimidinyl]-N-methylmethanesulfonamide

IH 25 MG, 50 MG IH

PA 18 14540 Rosuvastatin t-Butyl Ester(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-

IH 25 MG, 50 MG IH

(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid t-butyl ester

PA 18 14550 Rosuvastatin Acetonide t-Butyl Estertert-Butyl 6-[(1E)-2-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]ethenyl]-2,2-dimethyl-1,3-dioxane-4-acetate

IH 25 MG, 50 MG IH

PA 18 14560 Rosuvastatin Methyl Ester IH 25 MG 50 MG IHPA 18 14560 Rosuvastatin Methyl Ester

(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-

IH 25 MG, 50 MG IH

PA 18 14570 Rosuvastatin Ethyl Ester

(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid ethyl ester

IH 25 MG, 50 MG IH

PA 18 14580 Rosuvastatin Isopropyl Ester(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid isopropyl ester

IH 25 MG, 50 MG IH

PA 18 14590 Rosuvastatin Sodium 3-Oxo Impurity IH 25 MG, 50 MG IH

PA 18 14600 Ros astatin Sodi m 5 O o Imp rit IH 25 MG 50 MG IHPA 18 14600 Rosuvastatin Sodium 5-Oxo Impurity IH 25 MG, 50 MG IH

PA 18 14610 Rosuvastatin Sodium (3R,5R)-Isomer(3R,5R,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid sodium salt

IH 25 MG, 50 MG IH

PA 18 14620 R t ti S di (3S 5S) I IH IHPA 18 14620 Rosuvastatin Sodium (3S,5S)-Isomer(3S,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid sodium salt

IH 25 MG, 50 MG IH

PA 18 14630 Rosuvastatin Sodium (3S,5R)-Isomer(3S,5R,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid sodium salt

IH 25 MG, 50 MG IH

hept-6-enoic acid sodium salt

PA 19 01000 Saccharin Sodium API 25 MG, 50 MG EP

PA 19 02000 Salbutamol Sulphate API 25 MG, 50 MG EP

PA 19 02030 (1RS) 2 [(1 1 Di th l th l) i ] 1 (4 h d 3 IMP C EPPA 19 02030 (1RS)-2-[(1,1-Dimethylethyl)-amino]-1-(4-hydroxy-3-methylphenyl)-ethanol


PA 19 02080 4-[2-[(1,1-Dimethylethyl)amino]ethyl]-2-methylphenol IMP H 25 MG, 50 MG EP

PA 19 03000 Salicylic Acid API 25 MG, 50 MG EP

PA 19 03010 4-Hydroxybenzoic Acid IMP A 25 MG, 50 MG EP

PA 19 03020 4-Hydroxyisophthalic Acid IMP B 25 MG, 50 MG EP

PA 19 03030 Phenol IMP C 25 MG 50 MG EPPA 19 03030 Phenol IMP C 25 MG, 50 MG EP

PA 19 03510 N,N-Diethylsalicylamide IH 25 MG, 50 MG IH

PA 19 04000 Secnidazole API 25 MG, 50 MG EP

PA 19 04510 2-Methyl-4-nitroimidazole IH 25 MG, 50 MG IH

PA 19 05000 Selegiline Hydrochloride API 25 MG, 50 MG EP

PA 19 05030 Phenylpropanolamine Hydrochloride IMP C 25 MG 50 MG EPPA 19 05030 Phenylpropanolamine Hydrochloride IMP C 25 MG, 50 MG EP

PA 19 06000 Sertraline Hydrochloride API 25 MG, 50 MG EP

PA 19 07000 Sertraline API 25 MG, 50 MG EP

PA 19 07010 (+/-)-trans-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine


PA 19 07020 (1RS,4RS)-N-Methyl-4-phenyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride


PA 19 07030 (1RS,4RS)-4-(4-Chlorophenyl)-N-Methyl-1,2,3,4- IMP C 25 MG, 50 MG EP( , ) ( p y ) y , , ,tetrahydronaphthalen-1-amine Hydrochloride

25 MG, 50 MG

PA 19 07040 as Racemate: Hydroxyphenylacetic Acid (Mandelic Acid) IMP D 25 MG, 50 MG EP

PA 19 07050 (2R)-Hydroxyphenylacetic Acid ((R)-Mandelic Acid) IMP E 25 MG, 50 MG EP

PA 19 07060 R t 4 (3 4 Di hl h l) 3 4 dih d hth l IMP F EP

H

NHHCH3

H

O

H

NHCH3H

PA 19 07060 as Racemate: 4-(3,4-Dichlorophenyl)-3,4-dihydronaphthalen-1(2H )-one (Sertraline Tetralone Derivative)


PA 19 07070 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine ((1R,4R)enantiomer)


PA 19 07510 Isomer of 2,3 Dichloro Sertralone IH 25 MG, 50 MG EP

H

NHHCH3

H

O

H

NHCH3HPA 19 07520 Isomer of 2,3 Dichloro Serteraline IH 25 MG, 50 MG IH

PA 19 07530 Trans form of 2,3 Dichloro Sertraline IH 25 MG, 50 MG IH

PA 19 07540 Cis form of 2 3 Dichloro Sertraline IH 25 MG 50 MG IH

H

NHHCH3

H

O

H

NHCH3H

PA 19 07540 Cis form of 2,3 Dichloro Sertraline IH 25 MG, 50 MG IH

PA 19 08000 Sildenafil Citrate API 25 MG, 50 MG EP

PA 19 09000 Sildenafil API 25 MG, 50 MG EP

H

NHHCH3

H

O

H

NHCH3H

PA 19 09510 Sildenafil N-Oxide IH 25 MG, 50 MG IH

PA 19 10000 Silybin API 25 MG, 50 MG EP

PA 19 11000 Simvastatin API 25 MG 50 MG EP

H

NHHCH3

H

O

H

NHCH3H

PA 19 11000 Simvastatin API 25 MG, 50 MG EP

PA 19 11010 (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-Dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Tenivastatin Sodium Salt; Simvastatin Hydroxy Acid Sodium Salt)


H

NHHCH3

H

O

H

NHCH3H

PA 19 11020 Simvastatin Acetate Ester ; Imp B 25 MG, 50 MG EP

PA 19 11030 Anhydro Simvastatin Imp C 25 MG, 50 MG EP

PA 19 11040 Simvastatin Dimer Imp D 25 MG, 50 MG EP

H

NHHCH3

H

O

H

NHCH3H

PA 19 11050 Lovastatin IMP E 25 MG, 50 MG EP

H

NHHCH3

H

O

H

NHCH3H

PA 19 11060 Simvastatin ; epi-Lovastatin Imp F 25 MG, 50 MG EP

PA 19 11070 Si t ti I G EP

NH2

PA 19 11070 Simvastatin Imp G 25 MG, 50 MG EP

PA 19 11080 Anhydro Simvastatin Acid Sodium Salt IH 25 MG, 50 MG IH

PA 19 11510 Simvastatin Methyl Ester IH 25 MG, 50 MG IH

NH2

PA 19 11520 Simvastatin Ethyl Ester IH 25 MG, 50 MG IH

PA 19 11530 Simvastatin Glycerol Ester IH 25 MG, 50 MG IH

PA 19 11540 Simvastatin Acid Ammonium Salt IH 25 MG 50 MG IH

NH2

PA 19 11540 Simvastatin Acid Ammonium Salt IH 25 MG, 50 MG IH

PA 19 12000 Sodium Benzoate API 25 MG, 50 MG EP

PA 19 13000 Sodium Cromoglicate API 25 MG, 50 MG EP

NH2

PA 19 13510 2',6'-Dihydroxyacetophenone IH 25 MG, 50 MG IH

PA 19 14000 Sodium Cyclamate API 25 MG, 50 MG EP

PA 19 14510 Cyclamic Acid IH 25 MG 50 MG IH

NH2

PA 19 14510 Cyclamic Acid IH 25 MG, 50 MG IH

PA 19 14020 Aniline (Phenylamine ) IMP B 25 MG, 50 MG EP

PA 19 14030 Cyclohexanamine IMP C 25 MG, 50 MG EP

NH2

PA 19 14040 N-Cyclohexylcyclohexanamine IMP D 25 MG, 50 MG EP

PA 19 15000 Sodium Fluoride API 25 MG, 50 MG EP

PA 19 16000 Sodium Thiophene-2-carboxylate API 25 MG, 50 MG EP

NH2

p y 25 MG, 50 MG

PA 19 17000 Sorbic Acid API 25 MG, 50 MG EP

NH2

PA 19 18000 Sotalol Hydrochloride API 25 MG, 50 MG EP

PA 19 19000 Spironolactone API 25 MG, 50 MG EP

PA 19 20000 Stavudine API 25 MG, 50 MG EP

PA 19 20010 5-Methylpyrimidine-2,4(1H,3H)-dione (Thymine) IMP A 25 MG, 50 MG EP

PA 19 20030 1-(2-Deoxy-b-D-erythro-pentofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione (Thymidine)


PA 19 21000 Strychnine Nitrate API 25 MG, 50 MG EP

PA 19 21510 Strychnine N Oxide Hydrochloride IH 25 MG 50 MG IHPA 19 21510 Strychnine N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 19 22000 Sulfacetamide API 25 MG, 50 MG EP

PA 19 23000 Sulfacetamide Sodium Monohydrate API 25 MG, 50 MG EP

PA 19 23010 Sulfanilamide IMP A 25 MG, 50 MG EP

PA 19 24000 Sulfadiazine API 25 MG, 50 MG EP

PA 19 24010 Pyrimidin-2-amine IMP A 25 MG 50 MG EPPA 19 24010 Pyrimidin-2-amine IMP A 25 MG, 50 MG EP

PA 19 24020 4-Aminobenzenesulfonic Acid (Sulphanilic Acid) IMP B 25 MG, 50 MG EP

PA 19 24040 4-Aminobenzenesulfonamide (Sulfanilamide) IMP D 25 MG, 50 MG EP

PA 19 24510 N4-Acetylsulfadiazine IH 25 MG, 50 MG IH

PA 19 25000 Sulfadimidine API 25 MG, 50 MG EP

PA 19 25010 4-Amino-N-(4-methyl-2- pyrimidyl)benzenesulphonamide IMP A 25 MG, 50 MG EP( y py y ) p(Sulfamerazine)

25 MG, 50 MG

PA 19 25020 4-Amino-N-pyrimidin-2- ylbenzenesulphonamide (Sulfadiazine)


PA 19 25030 (4-Aminophenylsulphonyl)- guanidine (Sulfaguanidine) IMP C 25 MG, 50 MG EP

PA 19 25040 4 A i b l h id (S lf il id ) IMP D EPPA 19 25040 4-Aminobenzenesulphonamide (Sulfanilamide) IMP D 25 MG, 50 MG EP

PA 19 25050 N-[(4-Aminophenyl)sulfonyl]- acetamide (Sulfacetamide) IMP E 25 MG, 50 MG EP

PA 19 25060 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) IMP F 25 MG, 50 MG EP

PA 19 26000 Sulfadimethoxine Sodium API 25 MG, 50 MG EP

PA 19 27000 Sulfafurazole API 25 MG, 50 MG EP

PA 19 28000 Sulfaguanidine API 25 MG 50 MG EPPA 19 28000 Sulfaguanidine API 25 MG, 50 MG EP

PA 19 28010 4-Aminobenzenesulphonamide (Sulphanilamide) IMP A 25 MG, 50 MG EP

PA 19 28020 N-[(4-Aminophenyl)sulphonyl]-urea (Sulphacarbamide) IMP B 25 MG, 50 MG EP

PA 19 29000 Sulfamerazine API 25 MG, 50 MG EP

PA 19 29510 Sulphanilamide IH 25 MG, 50 MG IH

PA 19 30000 Sulfamethoxazole API 25 MG 50 MG EPPA 19 30000 Sulfamethoxazole API 25 MG, 50 MG EP

PA 19 30010 N-[4-[(5-Methylisoxazol-3-yl)-sulphamoyl]phenyl]acetamide IMP A 25 MG, 50 MG EP

PA 19 30020 4-[[(4-Aminophenyl)sulphonyl]-amino]-N-(5-methylisoxazol-3-yl)benzenesulphonamide


PA 19 30030 5-Methylisoxazol-3-amine IMP C 25 MG, 50 MG EP

PA 19 30040 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) IMP D 25 MG, 50 MG EP

PA 19 30050 4-Aminobenzenesulphonamide (Sulphanilamide) IMP E 25 MG, 50 MG EPp ( p ) 25 MG, 50 MG

PA 19 31000 Sulfaquinoxaline Sodium API 25 MG, 50 MG EP

PA 19 32000 Sulfasalazine API 25 MG, 50 MG EP

PA 19 32080 S li li A id IMP H EPPA 19 32080 Salicylic Acid IMP H 25 MG, 50 MG EP

PA 19 33000 Sulfathiazole API 25 MG, 50 MG EP

PA 19 34000 Sulindac API 25 MG, 50 MG EP

PA 19 35000 Sulpiride API 25 MG, 50 MG EP

PA 19 35020 Methyl 2-Methoxy-5-sulphamoylbenzoate IMP B 25 MG, 50 MG EP

PA 19 35030 Ethyl 2 Methoxy 5 sulphamoylbenzoate IMP C 25 MG 50 MG EPPA 19 35030 Ethyl 2-Methoxy-5-sulphamoylbenzoate IMP C 25 MG, 50 MG EP

PA 19 35040 2-Methoxy-5-sulphamoylbenzoic Acid IMP D 25 MG, 50 MG EP

PA 19 35050 2-Methoxy-5-sulphamoylbenzamide IMP E 25 MG, 50 MG EP

PA 19 35060 1-Ethyl-2-[[(2-methoxy-5-sulphamoylbenzoyl)amino]methyl]pyrrolidine 1-Oxide (Sulpiride N-Oxide)


PA 19 36000 Suplatast Tosilate API 25 MG, 50 MG EP

PA 19 36510 Methyl Toluene-4-sulphonate IH 25 MG, 50 MG IH

PA 19 37000 Sildenafil Aldehyde Impurity 2-Ethoxy-5-(4-methyl-piperazin-1-yl-sulphonyl)-benzaldehyde

API 25 MG, 50 MG EP

PA 19 37510 Sildenafil Amide Impurity 4 A i 1 th l 3 l l 5 b id

IH 25 MG, 50 MG IH4-Amino-1-methyl-3-propylpyrazole-5-carboxamide

PA 19 37520 Sildenafil Amide Impurity Hydrochloride 4-Amino-1-methyl-3-propylpyrazole-5-carboxamide Hydrochloride

IH 25 MG, 50 MG IH

PA 19 37530 Sildenafil Chloro Impurity 2-Ethoxybenzoyl chloride

IH 25 MG, 50 MG IHy y

PA 19 37540 Sildenafil Carboxamide Impurity 4-(2-Ethoxybenzamido)-1-methyl-3-n-propylpyrazole-5-carboxamide

IH 25 MG, 50 MG IH

PA 19 37550 Sildenafil Lactam Impurity 5-(2-ethoxyphenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazole[4,3-d]pyrimidine-7-one

IH 25 MG, 50 MG IH

PA 19 37560 Sildenafil Chlorosulfonyl Impurity 5-(5-chlorosulfonyl-2-ethoxyphenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazole[4,3-d]pyrimidine-7-one

IH 25 MG, 50 MG IH

PA 19 38000 Sodium Ethyl Parahydroxybenzoate API 25 MG, 50 MG EP

PA 19 38010 4-Hydroxybenzoic Acid IMP A 25 MG 50 MG EPPA 19 38010 4-Hydroxybenzoic Acid IMP A 25 MG, 50 MG EP

PA 19 38020 Methyl 4-Hydroxybenzoate(Methyl Parahydroxybenzoate) IMP B 25 MG, 50 MG EP

PA 19 38030 Propyl 4-Hydroxybenzoate(Propyl Parahydroxybenzoate) IMP C 25 MG, 50 MG EP

PA 19 38040 Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate) IMP D 25 MG, 50 MG EP

PA 20 01000 Tamoxifen Citrate API 25 MG, 50 MG EP

PA 20 01040 2-[4-[(Z)-1,2-Diphenylprop-1-enyl]phenoxy]-N,N- IMP D 25 MG, 50 MG EPPA 20 01040 2 [4 [(Z) 1,2 Diphenylprop 1 enyl]phenoxy] N,Ndimethylethanamine


PA 20 01070 (2RS)-1-[4-[2-(Dimethylamino)-ethoxy]phenyl]-2-phenylbutan-1-one


PA 20 01510 1,2-Diphenylbutan-1-one IH 25 MG, 50 MG IH

PA 20 01520 Tamoxifen N-Oxide IH 25 MG, 50 MG IH

PA 20 02000 Tamsulosin Hydrochloride API 25 MG, 50 MG EP

PA 20 02010 5-[(2R )-2-[Bis[2-(2-ethoxyphenoxy)ethyl]amino]-propyl]-2- IMP A 25 MG, 50 MG EPmethoxybenzenesulfonamide Hydrochloride

PA 20 02020 5-[(2R )-2-Aminopropyl]-2-methoxybenzene-sulfonamide Hydrochloride


PA 20 02030 2-Methoxy-5-[(2R )-2-[(2-phenoxyethyl)amino]propyl]-benzenesulfonamide Hydrochloride


PA 20 02060 2-(2-Ethoxyphenoxy)ethanamine Hydrochloride IMP F 25 MG, 50 MG EP

PA 20 03000 Temazepam API 25 MG, 50 MG EP

PA 20 03010 [5-Chloro-2-(methylamino)-phenyl]phenylmethanone (5-Chloro-2-(methylamino)benzophenone)


PA 20 03020 O IMP B EPPA 20 03020 Oxazepam IMP B 25 MG, 50 MG EP

PA 20 04000 Tenoxicam API 25 MG, 50 MG EP

PA 20 04010 Pyridin-2-amine IMP A 25 MG, 50 MG EP

PA 20 04020 Methyl 4-Hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-3-carboxylate 1,1-Dioxide


PA 20 04030 N -Methylthiophene-2-carboxamide IMP C 25 MG, 50 MG EP

PA 20 04040 N Methyl N '' (pyridin 2 yl) ethanediamide IMP D 25 MG 50 MG EPPA 20 04040 N -Methyl-N ''-(pyridin-2-yl)-ethanediamide IMP D 25 MG, 50 MG EP

PA 20 04050 2-Methylthieno[2,3-d ]isothiazol-3(2H )-one 1,1-Dioxide IMP E 25 MG, 50 MG EP

PA 20 04080 3-[(Methylamino)sulfonyl]-thiophene-2-carboxylic Acid IMP H 25 MG, 50 MG EP

PA 20 05000 Terazosin Hydrochloride Dihydrate API 25 MG, 50 MG EP

PA 20 05010 2-Chloro-6,7-dimethoxyquinazolin-4-amine IMP A 25 MG, 50 MG EP

PA 20 05020 1-(4-Hydroxy-6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)- IMP B 25 MG 50 MG EPPA 20 05020 1-(4-Hydroxy-6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)-tetrahydrofuran- 2-yl]carbonyl]piperazine


PA 20 05030 6,7-Dimethoxy-2-(piperazin- 1-yl)quinazolin-4-amine IMP C 25 MG, 50 MG EP

PA 20 05040 1-(4-Amino-6,7- dimethoxyquinazolin-2-yl)-4-formylpiperazine Hydrochloride


PA 20 05050 2,2'-(Piperazine-1,4-diyl)bis(6,7- dimethoxyquinazolin-4-amine)


PA 20 05110 Prazosin Hydrochloride IMP K 25 MG, 50 MG EP

PA 20 05120 1-(Furan-2-ylcarbonyl)piperazine IMP L 25 MG, 50 MG EP( y y )p p 25 MG, 50 MG

PA 20 05130 1,4-Bis(furan-2-ylcarbonyl)- piperazine IMP M 25 MG, 50 MG EP

PA 20 05140 1-[[(2RS)-Tetrahydrofuran-2- yl]carbonyl]piperazine IMP N 25 MG, 50 MG EP

PA 20 05150 1 4 Bi [(t t h d f 2 l) b l] i i IMP O EPPA 20 05150 1,4-Bis[(tetrahydrofuran-2- yl)carbonyl]piperazine IMP O 25 MG, 50 MG EP

PA 20 06000 Terbinafine Hydrochloride API 25 MG, 50 MG EP

PA 20 06010 N-Methyl-C-(naphthalen-1-yl)methanamine Hydrochloride (Secundary Amine Hydrochloride)

IMP A 25 MG, 50 MG EP(Secu da y e yd oc o de)

PA 20 06020 (2Z)-N,6,6-Trimethyl-N(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (cis-Terbinafine Hydrochloride)


PA 20 06030 (2E)-N,6,6-Trimethyl-N(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (trans-iso-Terbinafine Hydrochloride)


PA 20 06040 (2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]-hept-2-en-4-yn-1-amine Hydrochloride (4-Methylterbinafine Hydrochloride)


PA 20 06510 N-Demethylterbinafine Hydrochloride IH 25 MG, 50 MG IH

PA 20 07000 Terbutaline Sulphate API 25 MG, 50 MG EPp ,

PA 20 07010 3,5-Dihydroxybenzoic Acid (a-Resorcylic Acid) IMP A 25 MG, 50 MG EP

PA 20 08000 Terfenadine API 25 MG, 50 MG EP

PA 20 08010 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butan-1-one (Terfenadone)


PA 20 08090 Diphenyl(piperidin-4-yl)methanol (Azacyclonol) IMP I 25 MG, 50 MG EP

PA 20 09000 Testosterone API 25 MG, 50 MG EP

PA 20 09010 Androst-4-ene-3,17-dione (Androstenedione) IMP A 25 MG, 50 MG EP

PA 20 09030 17a-Hydroxyandrost-4-en-3-one (Epitestosterone) IMP C 25 MG, 50 MG EP

PA 20 09050 3-Oxoandrost-4-en-17b-yl Acetate (Testosterone Acetate) IMP E 25 MG, 50 MG EP

PA 20 09060 17b-Hydroxy-5a-androstan-3-one (Androstanolone, Stanolon IMP F 25 MG, 50 MG EP

PA 20 09070 Androsta-1,4-diene-3,17-dione(Androstadienedione) IMP G 25 MG, 50 MG EP

PA 20 09080 17b H d d t 1 4 di 3 (B ld ) IMP H EPPA 20 09080 17b-Hydroxyandrosta-1,4-dien-3-one (Boldenone) IMP H 25 MG, 50 MG EP

PA 20 10000 Testosterone Benzoate API 25 MG, 50 MG EP

PA 20 10510 Testosterone IH 25 MG, 50 MG IH

PA 20 10520 Benzoic Acid IH 25 MG, 50 MG IH

PA 20 11000 Testosterone Enantate API 25 MG, 50 MG EP

PA 20 11020 3 Oxoandrost 4 en 17b ylHexanoate (Testosterone IMP B 25 MG 50 MG EPPA 20 11020 3-Oxoandrost-4-en-17b-ylHexanoate (Testosterone Caproate)


PA 20 11040 17b-Hydroxyandrost-4-en-3-one (Testosterone) IMP D 25 MG, 50 MG EP

PA 20 12000 Testosterone Isocaproate API 25 MG, 50 MG EP

PA 20 12010 Testosterone IMP A 25 MG, 50 MG EP

PA 20 12020 3-Oxoandrost-4-en-17b-ylAcetate (Testosterone Acetate) IMP B 25 MG, 50 MG EP

PA 20 12030 Testosterone Propionate IMP C 25 MG 50 MG EPPA 20 12030 Testosterone Propionate IMP C 25 MG, 50 MG EP

PA 20 12040 3-Oxoandrost-4-en-17b-yl2-Methylpropanoate (Testosterone Isobutyrate)


PA 20 12050 3-Oxoandrost-4-en-17b-ylHexanoate (Testosterone Caproate)


PA 20 12060 Testosterone Enantate IMP F 25 MG, 50 MG EP

PA 20 13000 Testosterone Propionate API 25 MG, 50 MG EP

PA 20 13010 3-Oxoandrost-4-en-17b-yl Acetate (Testosterone Acetate) IMP A 25 MG, 50 MG EPy ( ) 25 MG, 50 MG

PA 20 13020 3-Oxoandrost-4-en-17b-yl 2-Methylpropanoate (Testosterone Isobutyrate)


PA 20 13030 Testosterone IMP C 25 MG, 50 MG EP

PA 20 14000 Tetracaine Hydrochloride API 25 MG, 50 MG EP

PA 20 14010 4-Aminobenzoic Acid IMP A 25 MG, 50 MG EP

PA 20 14020 4-(Butylamino)benzoic Acid IMP B 25 MG, 50 MG EP

PA 20 14030 Methyl 4-(Butylamino)benzoate IMP C 25 MG, 50 MG EP

PA 20 14510 Tetracaine N-Oxide IH 25 MG, 50 MG IH

PA 20 15000 Tetracycline Hydrochloride API 25 MG 50 MG EPPA 20 15000 Tetracycline Hydrochloride API 25 MG, 50 MG EP

PA 20 16000 Tetramisole Hydrochloride API 25 MG, 50 MG EP

PA 20 17000 Thalidomide API 25 MG, 50 MG EP

PA 20 18000 Theobromine API 25 MG, 50 MG EP

PA 20 19000 Theophylline API 25 MG, 50 MG EP

PA 20 19010 Caffeine IMP A 25 MG 50 MG EPPA 20 19010 Caffeine IMP A 25 MG, 50 MG EP

PA 20 19020 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine) IMP B 25 MG, 50 MG EP

PA 20 19040 N-Methyl-5-(methylamino)-1H- imidazole-4-carboxamide (Theophyllidine)

IMP D 25 MG, 50 MG EP( p y )

PA 20 19060 Etofylline IMP F 25 MG, 50 MG EP

PA 20 19510 1-Methylxanthine IH 25 MG, 50 MG EP

PA 20 19520 7 Methylxanthine IH 25 MG 50 MG EPPA 20 19520 7-Methylxanthine IH 25 MG, 50 MG EP

PA 20 20000 Theophylline-Ethylenediamine API 25 MG, 50 MG EP

PA 20 20010 Caffeine IMP A 25 MG, 50 MG EP

PA 20 20020 3 M th l 3 7 dih d 1H i 2 6 di (3 IMP B EPPA 20 20020 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine)


PA 20 20060 Etofylline IMP F 25 MG, 50 MG EP

PA 20 21000 Thiamazole API 25 MG, 50 MG EP

PA 20 21020 1-Methyl-1H-imidazole IMP B 25 MG, 50 MG EP

PA 20 22000 Thiamine Hydrochloride API 25 MG, 50 MG EP

PA 20 22510 5 (2 Hydroxyethyl) 4 methylthiazole IH 25 MG 50 MG IHPA 20 22510 5-(2-Hydroxyethyl)-4-methylthiazole IH 25 MG, 50 MG IH

PA 20 23000 Thiamphenicol API 25 MG, 50 MG EP

PA 20 24000 Thioctic Acid API 25 MG, 50 MG EP

PA 20 25000 Thioridazine Hydrochloride API 25 MG, 50 MG EP

PA 20 25510 2-Methylthiophenothiazine IH 25 MG, 50 MG IH

PA 20 26000 Tiabendazole API 25 MG 50 MG EPPA 20 26000 Tiabendazole API 25 MG, 50 MG EP

PA 20 26010 Benzene-1,2-diamine IMP A 25 MG, 50 MG EP

PA 20 27000 Tiamulin Hydrogen API 25 MG, 50 MG EP

PA 20 27010 (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5,8-dihydroxy-4,6,9,10-tetramethyl-octahydro-3a,9-propano-3aH-cyclopentacyclo-octen-1(4H)-one (Mutilin)


PA 20 27020 2-(Benzylsulphanyl)-N,N-diethylethanamine Hydrochloride IMP B 25 MG, 50 MG EP

PA 20 27030 2,2'-(Disulphane-1,2-diyl)bis(N,N-diethylethanamine) IMP C 25 MG, 50 MG EP( p y ) ( y )Dihydrochloride

25 MG, 50 MG

PA 20 27050 (3aS,4R,6S,8R,9R,9aR,10R)-6-Ethenyl-4,6,9,10-tetramethyl-1,5-dioxodeca-hydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl [[2-(Diethylamino)ethyl]sulphanyl]-acetate (11-Oxotiamulin)


PA 20 27070 (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl Hydroxyacetate (Pleuromutilin)


PA 20 27100 (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl Acetate (Mutilin 14-Acetate)


PA 20 27510 Fumaric Acid IH 25 MG, 50 MG IH

PA 20 28000 Ti l idi H d hl id API 2 G 0 G EPPA 20 28000 Ticlopidine Hydrochloride API 25 MG, 50 MG EP

PA 20 28010 4,5,6,7-Tetrahydrothieno[3,2,c] pyridine hydrochloride IMP A 25 MG, 50 MG EP

PA 20 28020 6,7-Dihydrothieno[3,2-c]-pyridin-4(5H)-one IMP B 25 MG, 50 MG EP

PA 20 28040 5-Benzyl-4,5,6,7-tetrahydrothieno[3,2-c]-pyridine Hydrochloride IMP D 25 MG, 50 MG EP

PA 20 28050 5-(2-Chlorobenzyl)- thieno[3,2-c]pyridinium Chloride IMP E 25 MG, 50 MG EP

PA 20 28070 5-(3-Chlorobenzyl)-4 5 6 7-tetrahydrothieno-[3 2-c]pyridine IMP G 25 MG 50 MG EPPA 20 28070 5-(3-Chlorobenzyl)-4,5,6,7-tetrahydrothieno-[3,2-c]pyridine Hydrochloride


PA 20 28080 5-(4-Chlorobenzyl)-4,5,6,7-tetrahydrothieno-[3,2-c]pyridine Hydrochloride


PA 20 28120 5-(2-Chlorobenzyl)-6,7- dihydrothieno[3,2-c]pyridin-4(5H)-one

IMP L 25 MG, 50 MG EP

PA 20 28510 5-(2-Chlorobenzoyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine IH 25 MG, 50 MG IH

PA 20 29000 Tilidine Hydrochloride Hemihydrate API 25 MG, 50 MG EP

PA 20 29040 Ethyl (2RS)-3- Dimethylamino-2-phenylpropanoate IMP D 25 MG, 50 MG EPPA 20 29040 Ethyl (2RS) 3 Dimethylamino 2 phenylpropanoate IMP D 25 MG, 50 MG EP

PA 20 30000 Timolol Maleate API 25 MG, 50 MG EP

PA 20 30040 4-Morpholin-4-yl- 1,2,5-thiadiazol-3-ol IMP D 25 MG, 50 MG EP

PA 20 30510 N-Benzyl-tert.-butylamine IH 25 MG, 50 MG IH

PA 20 31000 Tinidazole API 25 MG, 50 MG EP

PA 20 31010 2-Methyl-5-nitro-1H-imidazole(2-Methyl-4-nitroimidazole IMP A 25 MG, 50 MG EP

PA 20 31020 1 [2 ( th l l h l) th l] 2 th l 4 it 1H i id l I B EPN

N

SCH3OO

CH3

O2N

PA 20 31020 1-[2-(ethylsulphonyl)ethyl]-2-methyl-4-nitro-1H-imidazole Imp B 25 MG, 50 MG EP

PA 20 32000 Tolazoline Hydrochloride API 25 MG, 50 MG EP

PA 20 32010 (4-Methylphenyl)-sulphonamide (Toluenesulphonamide; 4-ethylbenzenesulphonamide)


N

N

SCH3OO

CH3

O2N

et y be e esu p o a de)

PA 20 33000 Tolmetin Sodium Dihydrate API 25 MG, 50 MG EP

PA 20 34000 Tramadol Hydrochloride API 25 MG, 50 MG EP

PA 20 34010 (1RS 2SR) 2 [(Dimethylamino)methyl] 1 (3 IMP A 25 MG 50 MG EP

N

N

SCH3OO

CH3

O2N

PA 20 34010 (1RS,2SR)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanolHydrochloride


PA 20 34020 2-(3-Methoxyphenyl)cyclohex-1-enyl]-N,N-dimethylmethanamineHydrochloride


PA 20 34030 [2-(3-Methoxyphenyl)cyclohex-2-enyl]-N,N-dimethylmethanamineHydrochloride


N

N

SCH3OO

CH3

O2N

PA 20 34040 2-[(Dimethylamino)methyl]-1-(3-hydroxyphenyl)cyclohexanol Hydrochloride


PA 20 34050 2-[(Dimethylamino)methyl]-cyclohexanone Hydrochloride IMP E 25 MG, 50 MG EP

PA 20 34510 3-Bromoanisole IH 25 MG 50 MG IH

N

N

SCH3OO

CH3

O2N

PA 20 34510 3-Bromoanisole IH 25 MG, 50 MG IH

PA 20 34520 N-Desmethyltramadol Hydrochloride IH 25 MG, 50 MG IH

PA 20 34530 N-Desmethyltramadol Hydrochloride IH 25 MG, 50 MG IH

N

N

SCH3OO

CH3

O2N

PA 20 34540 N,O-Didesmethyltramadol Hydrochloride IH 25 MG, 50 MG IH

PA 20 34550 3-Methoxyphenol IH 25 MG, 50 MG IH

PA 20 34560 Tramadol N-Oxide IH 25 MG, 50 MG IH

N

N

SCH3OO

CH3

O2N

25 MG, 50 MG

PA 20 35000 Tranexamic Acid API 25 MG, 50 MG EP

N

N

SCH3OO

CH3

O2N

PA 20 35040 4-Aminomethylbenzoic Acid IMP D 25 MG, 50 MG EP

PA 20 36000 Trazodone Hydrochloride(BP) API 25 MG, 50 MG EP

PA 20 36010 4-(3-Chloro- phenyl)-1-[3-(3-oxo-2,3-dihydro-1,2,4- triazolo[4,3-a]pyridin-2-yl)propyl]piperazine N1-Oxide Hydrochloride (Trazodone N-Oxide Hydrochloride)


PA 20 36030 2-[3-[4-(4- Chlorophenyl)piperazin-1-yl]propyl]-1,2,4- IMP C 25 MG, 50 MG EPtriazolo[4,3-a]pyridin-3(2H)-one Dihydro- chloride

PA 20 36060 1-(3- Chloropropyl)-4-(3-chlorophenyl)- piperazine Hydrochloride


PA 20 36080 1,3-Bis- [4-(3-chlorophenyl)piperazin-1-yl]propane Dihydrochloride


PA 20 36510 1,2,4-Triazolo[4,3-a]pyridine-3(2H)-one IH 25 MG, 50 MG IH

PA 20 37000 Triacetin API 25 MG, 50 MG EP

PA 20 38000 Triamcinolone API 25 MG, 50 MG EP

PA 20 39000 Triamcinolone Acetonide API 25 MG, 50 MG EP

PA 20 39010 Triamcinolone IMP A 25 MG, 50 MG EP

PA 20 40000 Triamcinolone Hexacetonide API 25 MG, 50 MG EP

PA 20 40010 Triamcinolone Acetonide IMP A 25 MG, 50 MG EP

PA 20 41000 Triclabendazole API 25 MG, 50 MG EP

PA 20 42000 Triclosan API 25 MG, 50 MG EP

PA 20 43000 Trihexyphenidyl Hydrochloride API 25 MG, 50 MG EP

PA 20 43510 A t h IH IHPA 20 43510 Acetophenone IH 25 MG, 50 MG IH

PA 20 43520 Trihexyphenidyl N-Oxide IH 25 MG, 50 MG IH

PA 20 44000 Trimebutine API 25 MG, 50 MG EP

PA 20 44510 T i b ti M l t IH IHPA 20 44510 Trimebutine Maleate IH 25 MG, 50 MG IH

PA 20 44020 3,4,5-Trimethoxybenzoic Acid IMP B 25 MG, 50 MG EP

PA 20 44030 Methyl 3,4,5- Trimethoxybenzoate IMP C 25 MG, 50 MG EP

PA 20 45000 Trimetazidine Dihydrochloride API 25 MG, 50 MG EP

PA 20 45010 1-(3,4,5-Trimethoxybenzyl)piperazine Dihydrochloride IMP A 25 MG, 50 MG EP

PA 20 45020 1 4 Bis(2 3 4 trimethoxybenzyl)piperazine IMP B 25 MG 50 MG EPPA 20 45020 1,4-Bis(2,3,4-trimethoxybenzyl)piperazine IMP B 25 MG, 50 MG EP

PA 20 45030 2,3,4-Trimethoxybenzaldehyde IMP C 25 MG, 50 MG EP

PA 20 45040 (2,3,4-Trimethoxyphenyl)-methanol IMP D 25 MG, 50 MG EP

PA 20 45050 1-(2,4,5-rimethoxybenzyl)piperazine Dihydrochloride IMP E 25 MG, 50 MG EP

PA 20 45060 1-(2,4,6-Trimethoxybenzyl)piperazine Dihydrochloride IMP F 25 MG, 50 MG EP

PA 20 45070 Piperazine Hexahydrate IMP G 25 MG 50 MG EPPA 20 45070 Piperazine Hexahydrate IMP G 25 MG, 50 MG EP

PA 20 45080 Ethyl 4-(2,3,4-Trimethoxybenzyl)-piperazine-1-carboxylate IMP H 25 MG, 50 MG EP

PA 20 45090 1-Methyl-4-(2,3,4- trimethoxybenzyl)piperazine Dihydrochloride (N-Methyltrimetazidine Dihydrochloride)


PA 20 46000 TRIMETHOPRIM API 25 MG, 50 MG EP

PA 20 46040 2-Amino-5-(3,4,5- trimethoxybenzyl)pyrimidin-4-ol IMP D 25 MG, 50 MG EP

PA 20 46080 Methyl 3,4,5- Trimethoxybenzoate IMP H 25 MG, 50 MG EP

PA 20 46100 3,4,5-Trimethoxybenzoic Acid IMP J 25 MG, 50 MG EP

PA 20 46110 Aniline IMP K 25 MG, 50 MG EP

PA 20 46510 5 (3 4 5 T i th b l) i idi 2 4 di l IH IHPA 20 46510 5-(3,4,5-Trimethoxybenzyl)pyrimidin- 2,4-diol IH 25 MG, 50 MG IH

PA 20 46520 2-Amino-5-(4-hydroxy-3,5- dimethoxybenzyl)pyrimidin-4-ol IH 25 MG, 50 MG IH

PA 20 47000 Trimipramine Maleate API 25 MG, 50 MG EP

PA 20 47010 (2RS)-3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amineN-oxide (Trimipramine N-Oxide)


PA 20 47020 (2RS )-3-(10,11-Dihydro-5H -dibenzo[b,f]azepin-5-yl)-N ,2-dimethylpropan-i-amine Hydrochloride(Desmesthyltrimipramine Hydrochloride)


Hydrochloride(Desmesthyltrimipramine Hydrochloride)

PA 20 47030 (2RS)-3-(5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine


PA 20 47050 (2RS)-N-[(2RS)-3-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-2-methylpropyl]-N,N',N',2-tetramethylpropane-1,3-


diamine dihydrochloride

PA 20 47040 Imipramine Hydrochloride IMP D 25 MG, 50 MG EP

PA 20 47060 10,11-Dihydro-5H -dibenzo[b,f]-azepine (Iminodibenzyl) IMP F 25 MG, 50 MG EP

PA 20 48000 Tropicamide API 25 MG, 50 MG EP

PA 20 48010 N-(Pyridin-4-ylmethyl)- ethanamine IMP A 25 MG, 50 MG EP

PA 20 48030 3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) IMP C 25 MG, 50 MG EP

PA 20 48040 Phenylacetic Acid IMP D 25 MG, 50 MG EP

PA 20 49000 Tropisetron Hydrochloride API 25 MG, 50 MG EP

CPA 20 50000 Trospium Chloride API 25 MG, 50 MG EP

PA 20 50010 Hydroxydiphenylacetic Acid(Benzilic Acid) IMP A 25 MG, 50 MG EP

PA 20 51000 Tryptophan API 25 MG, 50 MG EP

PA 20 51510 N A t lt t h IH IHPA 20 51510 N-Acetyltryptophan IH 25 MG, 50 MG IH

PA 20 52000 Tyrosine API 25 MG, 50 MG EP

PA 20 53000 Tacrolimus Monohydrate API 25 MG, 50 MG EP

PA 20 53510 Ascomycin; Immunomycin; FK-520; IH 25 MG, 50 MG IH

PA 20 53520 Dihydro Tacrolimus; Dihydro FK-506 IH 25 MG, 50 MG IH

PA 20 54000 Telmisartan API 25 MG 50 MG EPPA 20 54000 Telmisartan API 25 MG, 50 MG EP

PA 20 54010 Telmisartan Imp A 25 MG, 50 MG EP

PA 20 54020 Telmisartan t-Butyl Ester Isomer Imp B 25 MG, 50 MG EP

PA 20 54030 Telmisartan t-Butyl Ester Imp C 25 MG, 50 MG EP

PA 20 55000 Tolterodine (Base) (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine

API 25 MG, 50 MG EP

PA 20 55510 Tolterodine Tartrate (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine tartrate

IH 25 MG, 50 MG IH

PA 20 55520 Tolterodine Hydrobromide Racemic RS N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine hydrobromide

IH 25 MG, 50 MG IH

PA 20 55530 (R)-N,N-Diisopropyl-3-(2-methoxy-5-methylphenyl)-3-phenylpropan-1-amine fumarate (" Tolterodine Methoxy Analog Fumarate " )

IH 25 MG, 50 MG USP

PA 20 55540 Tolterodine Monoisopropyl Analog (HCl) (R)-N-Isopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine hydrochloride

IH 25 MG, 50 MG IH

PA 20 55550 Tolterodine Hydroxymethyl Analog (R)-N-Diisopropyl-3-(2-hydroxy-5-hydroxymethylphenyl)-3-phenylpropan-1-amine

IH 25 MG, 50 MG IH

PA 20 56000 Topotecan API 25 MG, 50 MG EP

PA 20 56510 T t H d hl id IHPA 20 56510 Topotecan Hydrochloride 9-Dimethylaminomethyl-10-hydroxycamptothecin Hydrochloride

IH 25 MG, 50 MG IH

PA 20 56520 Topotecan Acetate 9-Dimethylaminomethyl-10-hydroxycamptothecin Acetate

IH 25 MG, 50 MG IH

PA 20 56530 Topotecan N-Desmethyl Metabolite 9-Methylaminomethyl-10-hydroxycamptothecin

IH 25 MG, 50 MG IH

PA 20 56540 Topotecan Acid Sodium Salt 9-Dimethylaminomethyl-10-hydroxycamptothecin Acid Sodium Salt

IH 25 MG, 50 MG IH

PA 20 57000 Trandolapril API 25 MG, 50 MG EP

PA 20 57010 (2S,3aR,7aS)-1-[N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl]hexahydro-2-indolinecarboxylic acid 1-methyl ester ; Trandolapril Methyl Ester


PA 20 57030 (2S, 3aR, 7aS)-1-[N-[(S)-1-Carboxy-3-cyclohexylpropyl]-L-l l]h h d 2 i d li b li id 1 th l t

Imp C 25 MG, 50 MG EPalanyl]hexahydro-2-indolinecarboxylic acid 1-ethyl ester ; Trandolapril Hexahydro Analog

PA 20 57040 (S)-ethyl 2-[(3S, 5aS, 9aR, 10aS)-3-Methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]-4-phenylbutanoate ; Trandolapril Diketopiperazine


PA 20 57050 (2S,3aR,7aS)-1-[N-[(S)-1-Carboxy-3-phenylpropyl]-L- Imp E 25 MG 50 MG EPPA 20 57050 (2S,3aR,7aS)-1-[N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl]hexahydro-2-indolinecarboxylic acid ; Trandolapril Diacid ; Trandolaprilat


PA 20 57510 Trandolapril Bicyclic Acid

L-(2S,3aR,7aS)-Octahydroindole-2-carboxylic Acid

IH 25 MG, 50 MG IH

PA 22 01000 Valaciclovir Hydrochloride API 25 MG, 50 MG EP

PA 22 01010 2-Amino-1,9-dihydro-6H -purin-6-one (Guanine) IMP A 25 MG, 50 MG EP

PA 22 01020 2-Amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H -purin-6-one(Aciclovir)


PA 22 01070 N,N -Dimethylpyridin-4-amine IMP G 25 MG, 50 MG EP

PA 22 02000 Valproic Acid API 25 MG, 50 MG EP

PA 22 02510 Sodium Valproate IH 25 MG, 50 MG IH

PA 22 02010 P t i A id (V l i A id) IMP A EPPA 22 02010 Pentanoic Acid (Valeric Acid) IMP A 25 MG, 50 MG EP

PA 22 02020 (2RS)-2-Ethylpentanoic Acid IMP B 25 MG, 50 MG EP

PA 22 02030 (2RS)-2-(1-Methylethyl)-pentanoic IMP C 25 MG, 50 MG EP

PA 22 02060 2-Propylpentanamide IMP F 25 MG, 50 MG EP

PA 22 02080 Pentanenitrile (Valeronitrile) IMP H 25 MG, 50 MG EP

PA 22 03000 Vancomycin Hydrochloride API 25 MG 50 MG EPPA 22 03000 Vancomycin Hydrochloride API 25 MG, 50 MG EP

PA 22 03010 Vancomycin

N-Desmethyl Vancomycin B



ß


[ß Asp3] Vancomycin B ; Vancomycin B Diacid

PA 22 03030 Agluco Vancomycin B ; Vancomycin B Aglycone Imp C 25 MG, 50 MG EP


Desvancosaminyl Vancomycin B


y yPA 22 03510 Vancomycin Didechloro Impurity

Didechloro Vancomycin B

IH 25 MG, 50 MG IH

PA 22 04000 Venlafaxine Hydrochloride API 25 MG, 50 MG EP

PA 22 04010 2 (4 Methoxyphenyl) N N dimethylethanamineHydrochloride IMP A 25 MG 50 MG EPPA 22 04010 2-(4-Methoxyphenyl)-N,N-dimethylethanamineHydrochloride IMP A 25 MG, 50 MG EP

PA 22 04020 3-(Dimethylamino)-2-(4-methoxyphenyl)propanoateHydrochloride


PA 22 04030 2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanolHydrochlorid IMP C 25 MG, 50 MG EP

PA 22 04040 1-(4-Methoxyphenyl)-2-(methylamino)ethyl]cyclohexanolHydrochloride


PA 22 04050 : (5RS)-5-(4-Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro-[5.5]undecane Hydrochloride


PA 22 04060 (2RS)-2-(Cyclohex-1-enyl)-2-(4-methoxyphenyl)-N,N-dimethylethanamine Hydrochloride


PA 22 04070 (2RS)-2-Cyclohexyl-2-(4-methoxyphenyl)-N,Ndimethylethanamine Hydrochloride


PA 22 04510 O-Desmethylvenlafaxine IH 25 MG, 50 MG IH

PA 22 05000 Verapamil Hydrochloride API 25 MG, 50 MG EP

PA 22 05010 N,N'- Bis[2-(3,4-dimethoxyphenyl)ethyl]- N,N'-dimethylpropane-1,3-diamine

IMP A 25 MG, 50 MG EPdimethylpropane-1,3-diamine

PA 22 05020 2-(3,4-Dimethoxyphenyl)-N-methylethanamine Hydrochloride IMP B 25 MG, 50 MG EP

PA 22 05030 2-(3,4- Dimethoxyphenyl)-N,N-dimethylethanamine Hydrochloride


PA 22 05040 3 Chl N [2 (3 4 di th h l) th l] N th l IMP D EPPA 22 05040 3-Chloro-N-[2-(3,4- dimethoxyphenyl)ethyl]-N-methylpropan-1-amine


PA 22 05050 (3,4-Dimethoxyphenyl)- methanol IMP E 25 MG, 50 MG EP

PA 22 05070 3,4-Dimethoxybenzaldehyde IMP G 25 MG, 50 MG EP

PA 22 05510 3,4-Dimethoxyphenylacetonitrile IH 25 MG, 50 MG IH

PA 22 05520 Verapamil N-Oxide Hydrochloride IH 25 MG, 50 MG IH

PA 22 06000 Vincamine API 25 MG 50 MG EPPA 22 06000 Vincamine API 25 MG, 50 MG EP

PA 22 07000 Vinpocetine API 25 MG, 50 MG EP

PA 22 08000 Voglibose API 25 MG, 50 MG EP

PA 22 08510 Tetrabenzyl Voglibose ("TBV") IH 25 MG, 50 MG IH

PA 22 08520 Tetrabenzyl Voglibose HCl ("TBV HCl") IH 25 MG, 50 MG IH

PA 22 08530 V li l i IHPA 22 08530 : Valiolamine IH 25 MG, 50 MG IH

PA 22 08540 Tetrabenzyl Cycloketone ("TBC") IH 25 MG, 50 MG IH

PA 22 08550 2,3,4,6-Tetra-O-benzyl-D-glucopyranose ("TBG") IH 25 MG, 50 MG IH

PA 22 09000 Voriconazole API/Imp A 25 MG, 50 MG EP

PA 22 09020 (2RS,3SR)-2-(2,4-Difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol


PA 22 09030 4 Ethyl 5 fluoropyrimidine Imp C 25 MG 50 MG EPPA 22 09030 4-Ethyl-5-fluoropyrimidine Imp C 25 MG, 50 MG EP

PA 22 09040 (2S,3R)-2-(2,4-Difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol


PA 22 09050 (+/-)-10-Camphorsulfonic acid Imp E 25 MG, 50 MG EP

PA 22 10000 Valsartan(For presentation only, not for sale)

(S)-N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valin

API 25 MG, 50 MG EP

PA 22 10010 (R)-N-Valeryl-N-([2'-(1H-tetrazole-5-yl)biphen-4-yl]methyl)valine ("Valsartan R-Isomer")


( Valsartan R-Isomer )

PA 22 10020 (S)-N-Butyryl-N-([2'-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine ("Valsartan N-Butyryl Analog")


PA 22 10030 (S)-N-Valeryl-N-([2'-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine benzyl ester ("Valsartan Benzyl Ester")

Imp C 25 MG, 50 MG USP

( Valsartan Benzyl Ester )

PA 22 10510 Valsartan Bromo Impurity 5-(4'-(Bromomethyl)(1,1'-biphenyl)-2-yl)-1-trityl-1H-tetrazole

IH 25 MG, 50 MG IH

PA 23 01000 Warfarin Sodium API 25 MG, 50 MG EP

PA 23 01020 4-Hydroxy-2H-1-benzopyran-2-one-(4-Hydroxycoumarin IMP B 25 MG, 50 MG EP

PA 24 01000 Xylazine Hydrochloride API 25 MG, 50 MG EP

PA 24 01010 2 6 Di th l ili (2 6 X lidi ) IMP A EPPA 24 01010 2,6-Dimethylaniline(2,6-Xylidine) IMP A 25 MG, 50 MG EP

PA 24 02000 Xylometazoline Hydrochloride API 25 MG, 50 MG EP

PA 24 02040 1-(1,1-Dimethylethyl)-3,5-dimethylbenzene IMP D 25 MG, 50 MG EP

PA 26 01000 Zidovudine API 25 MG, 50 MG EP

PA 26 01010 1-[(2R,5S)-5-(Hydroxymethyl)-2,5-dihydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione (Stavudine)


PA 26 01020 1 (3 chloro 2 3 dideoxy b D erythro pentofuranosyl) 5 Imp B 25 MG 50 MG EPPA 26 01020 1-(3-chloro-2,3-dideoxy-b-D-erythro-pentofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione


PA 26 01030 -Methylpyrimidine-2,4(1H,3H)-dione (Thymine) IMP C 25 MG, 50 MG EP

PA 26 01040 Triphenylmethanol IMP D 25 MG, 50 MG EP

PA 26 02000 Zolpidem Tartrate API 25 MG, 50 MG EP

PA 26 03000 Zopiclone API 25 MG, 50 MG EP

PA 26 03510 2-[6-Methyl-2-(4-methylphenyl)imidazo- [1,2-a]pyridin-3- IH 25 MG 50 MG IHPA 26 03510 2-[6-Methyl-2-(4-methylphenyl)imidazo- [1,2-a]pyridin-3-yl]acetamide

IH 25 MG, 50 MG IH

PA 26 03520 2-[6-Methyl-2-(4-methylphenyl)imidazo- [1,2-a]pyridin-3-yl]acetic Acid

IH 25 MG, 50 MG IH

PA 26 03530 Methyl 2-[6-Methyl-2-(4-methylphenyl)- imidazo[1,2-a]pyridin-3-yl]acetate

IH 25 MG, 50 MG IH

PA 26 03540 6-Methyl-2-(4-methylphenyl)imidazo- [1,2-a]pyridine-3-acetonitrile

IH 25 MG, 50 MG IH

PA 26 04000 Zolpidem N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide (Controlled Substance, for presentation only, not for

API 25 MG, 50 MG EP

( p yPA 26 04010 N,N-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazo[1,2-

a]pyridin-3-yl]acetamide ("Zolpidem 7-Methyl Isomer")


PA 26 04020 N,N-Dimethyl-2-(6-methyl-2-p-tolylimidazo[1,2-a]pyridin-3-yl)-2-oxoacetamide ("2-Oxo Zolpidem")


PA 26 04030 4-Methyl-N-(5-methylpyridin-2-yl)benzamide Imp C 25 MG, 50 MG EP

PA 26 04510 Zolpidem Acid 2-(6-Methyl-2-p-tolylimidazo[1,2-]pyridin-3-yl)acetic acid

IH 25 MG, 50 MG IH

PA 26 04520 Zolpidem Aldehyde 6-Methyl-2-p-tolylimidazo[1,2-]pyridine-3-carbaldehyde

IH 25 MG, 50 MG IH

PA 26 05000 Zonisamide API 25 MG, 50 MG EP

PA 26 05510 1,2-Benzisoxazole-3-methanesulfonylchloride IH 25 MG, 50 MG IH

PA 26 05520 Sodium 1,2-Benzisoxazole-3-methanesulfonate IH 25 MG, 50 MG IH

PA 26 05530 1,2-Benzisoxazole-3-methanecarbonic acid IH 25 MG, 50 MG IH

PA 26 06000 Zotarolimus API 25 MG, 50 MG EP

impurities.pdf · code product api / imp unit ref pa 01 01000 acebutolol hydrochloride api 25 mg,...

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