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Impurities

Sr. No. Name CAS No. BP
Code		 USP
Code		 EP
Code		 WHO
Code
ALLOPURINOL*
1 5-Amino-1H-pyrazole-4-carboxamide 5334-31-6 - A A -
2 5-(formylamino)-1H-pyrazole-4-carboxamide 22407-20-1 - B B -
3 Ethyl-5-amino-1H-pyrazole-4-carboxylate 103259-35-4 - D D -
4 Ethyl-5-(formylamino)-1H-pyrazole-4-carboxylate 31055-19-3 - E E -
5 3-Amino-4-carboxamide pyrazole hemisulfate (ASP) 27511-79-1 - - - -
6 3-Morphololino-2-cyanoacrylamide (MCA) 25229-97-4 - - - -
AMODIAQUINE HYDROCHLORIDE*
7 7-chloro-4-(4-hydroxy phenyl amino)-Quinoline - - - - -
8 N-{3-[(diethylamino)methyl]-4-hydroxyphenyl}-acetamide or Mannich Base - - - - -
9 N-(4-hydroxyphenyl)-acetamide [Paracetamol] 103-90-2 - - - -
10 4,7-Dichloroquinoline 86-98-6 - - - -
ARTEMETHER*/ARTESUNATE*/DIHYDROARTEMISININ*
11 Artemisinin 63968-64-9 - - - -
12 Dihydroartemisinin 81496-81-3 - - - -
13 α - Artemether 71939-51-0 - - - -
BISOPROLOL FUMARATE*
14 (RS)-1-(4-Hydroxymethylphenoxy)-3-isopropylaminopropan-2-ol or Bisoprolol impurity A 62572-93-4 - - A -
15 (RS)-1-Isopropylamino-3-[4-(2-propoxyethoxymethyl)phenoxy] propan-2-ol or Bisoprolol impurity B 1447715-44-7 - - B -
16 4[(2Isopropoxyethoxy) Methyl] Phenol (BS-1) 177034-57-0 - - B -
17 2-[[4-(2-isopropoxyethoxy)methyl]-phenoxymethyl]oxirane (BS-2) 66722-57-4 - - - -
4,7-DICHLOROQUINOLINE
18 4,5-Dichloroquinoline or 4,5-DCQ 21617-18-5 - - - -
19 7-Chloro-4-ethoxy quinoline 5448-52-2 - - - -
20 7-Chloro-4-hydroxyquinoline OR 7-chloroquinolin-4-ol 86-99-7 - - - -
21 5-Chloro-4-hydroxyquinoline OR 5-chloroquinolin-4-ol 101774-49-6 - - - -
FUROSEMIDE*
22 2,4 dichloro-5-Sulphamoyl benzoic acid [Lasamide] 2736-23-4 B - B -
23 2-amino-4-chloro-5-Sulphamoyl benzoic acid 3086-91-7 C - C -
24 2,4-dichlorobenzoic acid 50-84-0 E - E -
25 4-chloro-5-sulfamoylanthranilic acid 3086-91-7 - B - -
HYDROXYCHLOROQUINE SULPHATE*
26 4,7-Dichloroquinoline 86-98-6 - G - -
27 Mixture of diastereomers of 4-[(7-chloroquinolin-4-yl)amino]-N-ethyl-N-(hydroxyethyl) pentan-1-amine N-oxide orimpurity A - - A - -
28 2-[[(4RS)-4-[(7-chloroquinolin-4-yl)amino]pentyl]-(ethyl)amino]ethyl hydrogen sulfate or impurity B 103152-84-7 - B - -
29 7-chloro-4-[(2RS)-2-methylpyrrolidin-1-yl)quinoline or impurity F 6281-58-9 - F - -
30 Ethyl mono Ethanol amine (EMEA) 110-73-6 - - - -
31 2-((4-aminopentyl)(ethyl)amino)ethanol or Hydroxy novaldiamine (HNDA) 69559-11-1 - - - -
LUMEFANTRINE*
32 2,7-dichloro-4-fluorenyl ketone 7012-16-0 - - - -
33 2-chloro-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanone 131023-37-5 - - - -
34 2-dibutylamino-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanol 69759-61-1 - - - -
35 4-Chloro benzaldehyde 104-88-1 - - - -
36 Desbutyl Lumefantrine or (Z)-2-(butylamino)-1-(2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)ethanol 355841-11-1 - A - -
37 Epoxide or 2-Chloro-1-(2, 7-Dichloro-9h-fluoren-4-yl) Ethanone 53221-14-0 - - - -
NIMESULIDE*
38 N-(2,4-Dinitro-6-phenoxyphenyl)-methanesulphonamide 51765-56-1 A - A -
39 N-(2-phenoxyphenyl)-methanesulphonamide 51765- 51-6 B - B -
40 2-phenoxyaniline 2688-84-8 C - C -
41 4-nitro-2-phenoxyphenol 70995-08-3 D - D -
42 N,N’-(bis methylsulfonyl)-2-phenoxy aniline 905858-63-1 E - E -
43 N,N’-(bis methylsulfonyl)-2-phenoxy-4-nitro aniline 51765-72-1 F - F -
PIPERAQUINE PHOSPHATE*
44 7-chloro-4-piperazinyl quinoline 837-52-5 - - - -
45 1,4-bis-(4,7-dichloroquinoline)piperazine - - - - -
46 4-Piperazin-7-chloro-quinoline - - A - -
47 7-Chloro-4-{4-[3-(piperazin-1-yl)propyl]piperazin-1-yl}quinoline 4039-00-3 - B - -
48 5-Chloro-4-(4-{3-[4-(7-chloroquinolin-4-yl)piperazin-1-yl] propyl}piperazin-1-yl)quinoline 918879-09-1 - C - -
49 7-Chloroquinolin-4-ol 86-99-7 - D - -
50 4,4’-[Piperazine-1,4-diylbis(propane-3,1-diylpiperazine-4,1-diyl)]bis(7-chloroquinoline). 86486-21-7 - E - -
51 7-Chloro-4-(4-{3[(7-chloroquinolin-4-yl)oxy]propyl} piperazin-1-yl)quinoline 1233345-93-1 - F - -
52 N-(7-Chloroquinolin-4-yl)-N’-{3-[4-(7-chloroquinolin-4-yl) piperazin-1-yl]propyl}ethane-1,2-diamine - - G - -
53 4,4’-Piperazine-1,4-diylbis(7-chloroquinoline) - - H - -
54 7-Chloro-4-[4-(3-chloropropyl)piperazin-1-yl]quinoline 4038-99-7 - I - -
TENOFOVIR DISOPROXIL FUMARATE*
55 Tenofovir or (R)-[1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methyl phosphonic acid 147127-20-6 - - - -
56 Adenine or  9H-purin-6-amine 73-24-5 - - - -
57 Tenofovir disoproxil impurity A or Tenofovir related compound A or (S)-5-[[2-(6-Amino-9H-purin-9-yl)-1-methylethoxy] methyl]-2, 4, 6, 8-tetraoxa-5-phosphanonanedioic acid, bis (1-methylethyl) ester, 5-oxide, (E)-2-butenedioate (1:1). or S-isomer of Tenofovir disoproxilfumarate. - - A - -
58 (R)-9-(2-Hydroxypropyl)adenine or HPA 14047-28-0 - - - -
59 Tenofovir isoproxil monoester OR ({[(R) -1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methyl} (hydroxy) phosphoryloxy) methyl isopropyl carbonate 211364-69-1 - - - -
60 Des methyl Tenofovir Disoproxil OR O,O-Bis (isopropylcarbonyloxymethyl) [(6-amino-9H-purin-9yl)ethyloxy]methyl phosphonate 365417-53-4 - D (As Procedure-2) - -
61 Diethyl (tosyloxy) methyl phosphonate OR Diethoxy phosphoryl Tosylate 31618-90-3 - - - -
EMTRICITABINE*
Sr. No. Name CAS No. BP
Code		 USP
Code		 EP
Code		 WHO
Code
62 cis-5-[4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl]-1,3-oxathiolane-2-carboxylic acid (Emtricitabine acid) 1238210-10-0 - B - A
63 4-Amino-5-fluoropyrimidin-2(1H)-one (Fluoro cytosine) 2022-85-7 - A - E
64 L-Menthyl 5-(2R,5S)-[4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl]-1,3-oxathiolane-2-carboxylate (F-CME) 764659-72-5 - G - -
65 (2R,5R)-5-Hydroxy-1,3-oxathiolane-2-carboxylic acid (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester (HME) 147126-62-3 - - - -
66 2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxy methyl)-1, 3-oxathiolan-5-, (2R-cis)-; or (-)-1-[(2R, 5S)-2-(Hydroxymethyl)-1, 3-oxathiolan-5-cytosine. (Des Fluoro Emtricitabine) 34678-17-4 - D - C
67 Benzoic acid, 2-hydroxy-. (salicylic acid) 69-72-7 - F - -
PRIMAQUINE PHOSPHATE
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
68 6-Methoxy-8-amino quinoline (Primaquine phosphate impurity-1: Specified unidentified impurity; RRT.-0.24) 90-52-8 - Imp. at RRT.-0.24 - -
69 2,3-Dihydrophthalazine-1,4-dione (Primaquine phosphate impurity-2: Specified unidentified impurity; RRT.-0.29) 1445-69-8 - Imp. at RRT.-0.29 - -
70
2-(4-Bromopentyl)isoindoline 1,3-dione or 4-Bromo-1-phthalimido pentane (4-BPP)
59353-62-7
-
-
-
-
71
Potassium phthalimide 
1074-82-4
-
-
-
-
72
 1,4-dibromopentane
626-87-9
-
-

-

-
73
 2-(4-((6-methoxyquinolin-8-yl)amino)pentyl)isoindoline-1,3-dione sulfate [Isoindoline-1,3-dione]
-
-
-

-

-
74
 Bis isoindoline-1,3 dione impurity OR 2,2'-(pentane-1,4-diyl)bis(isoindoline-1,3-dione)
-
-
-
-
-
75 3-Nitro-4-acetyl amino anisole  or N-(4-methoxy-2-nitrophenyl)acetamide 119-81-3 - - - -
76 4-Methoxyacetanilide or N-(4-methoxyphenyl)acetamide 51-66-1 - - - -
77 4-Methoxy-2-Nitroaniline 96-96-8 - - - -
78 6-methoxy-8-nitroquinoline 85-81-4 - - - -
79 N-(6-methoxyquinolin-8-yl)hydroxylamine 57742-99-1 - - - -
EFAVIRENZ*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
80 USP EfavirenzRacemic mixture RS or
(RS)-6-Chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1H-benzo[d][1,3]oxazine-2(4H)-one 		177530-93-7 - USP Efavirenz Racemic mixture Rs - -
81 Efavirenz amino alcohol (Efavirenz amino carbinol) or
(S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-trifluorobut-3yn-2-ol		 209414-27-7 - A - E
82 N-Benzyl efavirenz OR (S)-6-chloro-4-(cyclopropylethynyl)-1-(4-methoxybenzyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one 174819-21-7 - I - D
83 Efavirenz benzoyl amino alcohol OR (S)-N-(4-chloro-2-(4-cyclopropyl-1, 1, 1-trifluoro-2-hydroxybut-3-yn-2-yl) phenyl)-4-methoxy benzamide - - J - A
84 Quinoline analog OR  6-chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline 391860-73-4 - K - F
85 Efavirenz amino alcohol ethyl carbamate OR
(S)-Ethyl 4-chloro-2-(4-cyclopropyl-1, 1, 1-trifluoro-2-hydroxybut-3-yn-2-yl) phenylcarbamate		 - - L - -
86 Efavirenz amino alcohol bis(ethoxycarbonyl)OR (S)-Ethyl 4-chloro-2-(4-cyclopropyl-2-(ethoxycarbonyloxy)-1, 1, 1-trifluorobut-3-yn-2-yl) phenylcarbamate - - N - -
87 Efavirenz amino alcohol methyl carbamate or
(S)-methyl 4-chloro-2-(4-cyclopropyl-1,1,1-trifluoro-2-hydroxybut-3-yn-2-yl)phenyl carbamate		 211563-41-6   H - H
88 4-Chloro-2-trifluoroacetyl aniline hydrochloride hydrate (Keto aniline OR E-2) 173676-59-0 - - - -
LAMIVUDINE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
89 (2RS, 5RS)-5-(4-aminp-2-oxopyrimidine-1(2H)-yl)-1,3-oxathiolane-2-carboxylicacid OR Lamivudine acid impurity 173829-09-9 - Specified imp.-1 A A
90 4-aminopyrimidin-2(1H)-one OR cytosine 71-30-7 - - E E
91 Pyrimidine-2,4-(1H, 3H)-dione OR Uracil 66-22-8 - - F F
92 1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolane-5-yl]pyrimidine-2,4-(1H,3H)-dione OR Lamivudine uridine analogue
 145986-07-8 - - J J
93 (2R,5S)-(1R,2S,5R)-2-iso propyl-5-methylcyclo hexyl 5-(4-amino-2-oxo pyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate (CME)
147027-10-9 - - - -
ATAZANAVIR SULFATE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
94 tert-butyl ((S)-1-((R)-oxiran-2-yl)-2-phenylethyl)carbamate (Boc Epoxy) 98760-08-8 - - - -
95 tert-butyl 2-((2S,3S)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-4-phenylbutyl) -2-(4-(pyridin-2-yl)benzyl)hydrazinecarboxylate or Des-N-(methoxycarbonyl)-L-tert-Leucine-Bis Boc Atazanavir orAtazanavir di-tert-butyl analog 198904-86-8 - - - -
96 (S)-2-((methoxycarbonyl)amino)-3,3-dimethylbutanoic acid orMethoxycarbonyl-L-tert-Leucine  OR MOC-L-tert-Leucine ORAtazanavir Related compound A 162537-11-3 - - - -
97 1H-benzo[d][1,2,3]triazol-1-ol hydrate (HOBT monohydrate) 123333-53-9 - - - -
98 4-(2-Pyridinyl)benzaldehyde OR Pyridinyl benzaldehyde 127406-56-8 - - - -
99 tert-butyl 2-(4-(pyridin-2-yl)benzyl) hydrazine carboxylate (Boc Hydrazine) 198904-85-7 - - - -
100 (2S, 3S)-1,2-epoxy-3-(Boc-amino)-4-phenyl butane OR (2S,3S)-Boc epoxy OR Boc-epoxy diastereomer impurity 98737-29-2
 - - - -
101 N'-(4-PYRIDIN-2-YL-BENZYLIDENE)-HYDRAZINECARBOXYLIC ACID _TERT_-BUTYL ESTER OR _TERT_-BUTYL [[4-(2-PYRIDINYL)PHENYL]METHYLENE]HYDRAZINECARBOXYLATE OR IMPURITY-A OF
BOC-HYDRAZINE OR BOC-HYDRAZINE (N-1 IMPURITY)		 198904-84-6
 - - - -
102 1-Ethyl-3-(3-dimethylaminopropyl)carbodiimide Hydrochloride  (EDC.HCl) 25952-53-8 - - - -
103 Racemic mixture (DL) of  Methoxy carbonyl-L-tert-Leucine  or  Methoxy carbonyl-DL-tert-Leucine - - - - -
104 4-(Pyridin-2-yl)benzoic acid OR 4-(2-Pyridyl)benzoic acid or  Pyridinyl benzoic acid 4385-62-0 - - - -
105 1-[4-(Pyridin-2-yl)phenyl]-5(S)-2,5-bis{[N-(methoxy-carbonyl)-D-tert-leucinyl]amino}-4(S)-hydroxy-6-phenyl-2-azahexane or Atazanavir diastereomer R, S, S, R 1292296-11-7 - - - -
106 1-[4-(Pyridin-2-yl)phenyl]-5(S)-2,5-bis{[N-(methoxy-carbonyl)-L-tert-leucinyl]amino}-4(R)-hydroxy-6-phenyl-2-azahexane or Atazanavir diastereomer S, S, R, S 1292296-09-3 - - - -
107 1-[4-(Pyridin-2-yl)phenyl]-5(S)-2,5-bis{[N-(methoxy-carbonyl)-D-tert-leucinyl]amino}-4(R)-hydroxy-6-phenyl-2-azahexane or Atazanavir diastereomer R, S, R, R - - - - -
SOFOSBUVIR*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
108 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetra hydrofuran-2~yl)pyrim idine-2,4(1H,3H)-dione or SFB Uridine or 2’-deoxy-2’-fluoro-2’-C-methyluridine 817204-32-3 - - - -
109 Isopropyl ((S)-2-(((2R,3R,4R,5R)-5-(2,4-dioxo~3 ,4-dlhydropyrlmidin- 1 (2H)-yl )-4-fluoro~2-((((S)-(((S)- 1 -i sopropoxy-1 -oxopropan-2- yl)amino)(phenoxy) phosphoryl)oxy)methyl)-4-methyltetrahydrofuran- 3-yl)oxy) (phenoxy)phosphory1)-L-a1aninate or SFB Dimer 1337482-17-3 - - - -
110 Isopropyl ((S)-(pertluorophenoxy)(phenoxy)phosphoryi)-L-alaninate or SFB-C or N-[(s)-(2,3,4,5,6-pentafluorophenoxy)phenoxyphosphinyl]-L-alanine-1-methylethyl ester 1334513-02-8 - - - -
111 2, 3, 4, 5, 6-pentafluorophenolOR Pentafluoro phenol 771-69-1 - - - -
SULFADOXINE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
112 Sulfanilamide or 4-aminobenzenesulfonamide 63-74-1 - - - A
113 4, 6-Dichloro-5-methoxy pyrimidine 5018-38-2 - - - -
114 4-amino-N-(6-chloro-5-methoxypyrimide-4-yl) benzenesulfonamide or 4-Amino-N-(6-chloro-5-methoxy-4-pyrimidinyl) benzenesulfonamide 5018-23-5 - - - -
115 N-(4-(N-(5,6-dimethoxypyrimidin-4-yl) sulfamoyl)phenyl)acetamide OR Impurity-C 5018-54-2 - - - C
116 5,6-dimethoxypyrimidin-4-amine OR Impurity-D 5018-45-1 - - - D
117 Sodium 5-methoxypyrimidine-4,6-bis(olate) or SMPB 5193-84-0 - - - -
PYRIMETHAMINE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
118 Pyrimethamine EP Impurity-A or 2-(4-chlorophenyl)-3-oxopentanenitrile. 55474-40-3 - - A -
119 Pyrimethamine EP Impurity-B or 5-(4-chlorophenyl)-6-methylpyrimidine-2,4-diamine 3275-44-3 - - B -
120 Pyrimethamine EP Impurity-C or (4-chlorophenyl) acetonitrile 140-53-4 - - C -
121 Pyrimethamine EP Impurity-D or (4-chlorophenyl)(2-ethyl-1,3-dioxolan-2-yl) acetonitrile 55474-41-4 - - D -
122 4-methylbenzenesulfonic acid or p-Toluene sulfonic Acid mono hydrate 6192-52-5 - - - -
123 Pyrimethamine ortho isomer impurity  or 5-(2-chlorophenyl)-6-ethylpyrimidine-2,4-diamine - -   - -
TENOFOVIR ALAFENAMIDE HEMIFUMARATE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
124 (2S, 2'S)-diisopropyl 2,2'-((((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphoryl)bis(azanediyl))dipropanoate or PMPA Bisamidate 1883563-86-7 - - - -
125 Phenyl hydrogen ((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphonate OR Monophenyl PMPA 379270-35-6
 - - - -
126 Phenol OR Benzenol 108-95-2 - - - -
127 4-Dimethyl amino pyridine OR Dimethylamino pyiridine 1122-58-3 - - - -
128 (S)-2-Aminopropionic acid OR L-α-Aminopropionic acid OR L-Alanine 56-41-7 - - - -
129 (S)-2-Amino-propionic acid isopropyl ester OR L-Alanine isopropyl ester HCl 62062-65-1 - - - -
130 Tenofovir Alafenamide System Suitability Mixture OR Tenofovir Alafenamide
(Ps): Diastereomer (PR)		 - - - - -
DOLUTEGRAVIR SODIUM*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
131 Diacetal-3-carboxylic acid impurity OR  1-(2,2-dimethoxyethyl)-5-methoxy-6-(methoxycarbonyl)-4-oxo- 1,4-dihydropyridine-3-carboxylic acid 1335210-23-5 - - - -
134 [1,3] Oxazine acid impurity OR (4R,12aS)-7-methoxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido [1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxylic acid 1335210-34-8 - - - -
135

[1,3] Oxazine Amide impurity OR (4R,12aS)-N-(2,4-difluorobenzyl)-7-methoxy-4,12a-dimethyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

 1335210-35-9 - - - -
136 2-desfluoro hydroxy impurity OR (4R,12aS)-N-(4-fluorobenzyl)-7-hydroxy-4,12a-dimethyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide 1863916-88-14 - - - -
137 4-desfluoro methoxy impurity OR (4R,12aS)-N-(2-fluorobenzyl)-7-hydroxy-4,12a-dimethyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide 1863916-87-3 - - - -
138 2,4-di desfluoro methoxy impurity OR (4R,12aS)-N-benzyl-7-hydroxy-4,12a-dimethyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide - - - - -
139 (4R,12aS)-N-(4-fluorobenzyl)-7-methoxy-4-methyl-6,8-dioxo-3,4,6,8, 12,12a-hexahydro-2H-pyrido[1',2':4,5] pyrazino[2,1-b][1,3]oxazine-9-carboxamide OR  2-Des fluoro methoxy - - - - -
140 (4R,12aS)-N-(2-fluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8, 12,12a-hexahydro-2H-pyrido[1',2':4,5] pyrazino[2,1-b][1,3]oxazine-9-carboxamide or 4-Des fluoro Dolutegravir 1863916-87-3 - - - -
141 (4S,12aR)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6 ,8,12,12a-hexahydro-2H-pyrido[1',2':4,5] pyrazino[2,1-b][1,3] oxazine-9-carboxamide or Dolutegravir Enantiomer (S, R) 1309560-49-3 - - - -
142 Racemic mixture of Dolutegravir [R,S] and Diastereomer [R,R] - - - - -
143 Racemic mixture of (S) 3-amino-1-butanol : (R) 3-amino-1-butanol - - - - -
144 Methyl 4-methoxy-3-oxobutanoate 41051-15-4 - - - -
145 (Z)-methyl 2-(((2,2-dimethoxyethyl)amino)methylene)-4-methoxy-3-oxobutanoate 1335210-26-8 - - - -
146 Dimethyl-1-(2,2-Dimethoxyethyl)-3-methoxy-4-oxo-1,4-dihydropyridine-2,5-dicarboxylate 1646862-02-3 - - - -
147 (4R, 12aS)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-Pyrido[1',2',4,5]pyrazino[2,1-b][1,3 ]oxazine-9-Carboxylic acid 1246616-73-8 - - - -
148 N-(2,4-Difluorobenzyl)-9-hydroxy-2-(4-hydroxy butan-2-yl)-1,8-dioxo-1,8-dihydro-2H-pyrido [2,1-a]pyrazine-7-carboxamide 1973402-05-9 - - - -
PREGABLIN*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
149 Lactum impurity or (4S)-4-(2-methylpropyl)pyrrolidin-2-one 61312-87-6 - C A -
150 Mandelic acid impurity or (2RS)-2-hydroxy-2-phenylacetic acid 90-64-2 - - C -
151

Pregabalin Racemic mixture or 3-(Amino methyl)-5-methylhaxanoic acid

 128013-69-4 - - B -
152 (R)-(­)-3-(carbamoyl methyl) -5-methyl hexanoic acid (R-CMH) 181289-33-8 - - - -
153 (+)-3-Carbamoymethyl-5-methylhexanoic acid (CMH) 181289-15-6 - - - -
154 1-methylethyl (2RS)-2-hydroxy-2-phenylacetate 4118-51-8 - - D -
155 (R)-(­)-3-(carbamoyl methyl)-5-methyl hexanoic acid or R-CMH system suitability mixture - - - - -
156 R-CMH Impurity-A or 3-isobutylglutaric acid or 3-isobutylpentanedioic acid or 3-(2-methylpropyl) pentanedioic Acid 75143-89-4 - - - -
157 R-CMH Impurity-B or D-α-Methylbenzylamineor(R)-(+)-1-Phenylethylamine 3886-69-9 - - - -
158

R-CMH Impurity-C or 4-(2-methylpropyl)piperidine-2,6-dione or 4-Isobutylpiperidine-2, 6-dione 3-Isobutylglutarimide.

 916982-10-0 - - - -
ACYCLOVIR*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
159 2-[[2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl]methoxy]ethyl acetate OR 9-[(2-Acetoxyethoxy) methyl]-N2-acetyl guanine OR Diacetyl acyclovir OR Impurity-G 75128-73-3 - - G G
160 N-(9-acetyl-6-oxo-6,9-dihydor-1H-purin-2-yl)acetamide (N2, 9-diacetyl guanine) OR Diacetyl Guanine OR Impurity-L 3056-33-5 - - L L
161

2-Amino-1,7-dihydro-6H-purine OR 2-Amino-9H-purin-6 (1H)-one OR Guanine OR Impurity-B

 73-40-5 - - B B
162 1,4-Diacetoxy-2-oxabutane or 2-[(2-Acetoxyethoxy)methoxy]-2-oxoethan-1-ylium or Dioxalane Diacetate 59278-00-1 - - - -
PYRONARIDINE TETRAPHOSPHATE*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
163 2,4-Dichloro benzoic acid (DCBA) 50-84-0 - - - -
164 5-Amino-2-methoxy pyridine (AMP) 6628-77-9 - - - -
165 N-[4-Hydroxy-3,5-bis(pyrrolidin-1-yl methyl) phenyl]acetamide (HPPA) - - - - -
166 4-Chloro-2-[(6-methoxypyridin-3-yl)amino]benzoic acid (CMBA) - - - - -
167 7,10-Dichloro-2-methoxy-5,10-dihydrobenzo[b]-1,5-naphthydine (DCNM) - - - - -
BICTEGRAVIR SODIUM*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
168

6-Desfluoro Bictegravir Free acid (GS-626446) OR (2R,5S,13aR)-N-(2,4-difluorobenzyl)-8-hydroxy-7,9-dioxo-2,3,4,5, 7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b] [1,3]oxazepine-10-carboxamide

 - - - - -
169

Bictegravir Amide OR Methyl 1-(2,2-dimethoxyethyl)-3-methoxy-4-oxo-5-((2,4,6-trifluorobenzyl)carbamoyl)-1,4-dihydropyridine-2-carboxylate

 1644158-10-0 - - - -
170

Bictegravir Dihydroxy OR Methyl 1-(2,2-dihydroxyethyl)-3-methoxy-4-oxo-5-((2,4,6-trifluorobenzyl)carbamoyl)-1,4-dihydropyridine-2-carboxylate

 - - - - -
171 Bictegravir Methoxy OR (2R,5S,13aR)-8-methoxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino [2,1-b][1,3]oxazepine-10-carboxamide - - - - -
172

Bictegravir System suitability mixture (Bictegravir sodium and GS-652240)

 - - - - -
173

Open Ring Bictegravir Free acid (GS-649086) OR 9-hydroxy-2-((1S,3R)-3-hydroxy cyclopentyl)-1,8-dioxo-N-(2,4,6-trifluorobenzyl)-2,8-dihydro-1H-pyrido[1,2-a]pyrazine-7-carboxamide

 - - - - -
NITRO FURANTOIN*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
174

1-Aminohydantoin Hydrochloride or 1-aminoimidazolidine-2,4-dione Hydrochloride

 2827-56-7 - - - -
175

5-Nitrofurfural Diacetate or (5-nitrofuran-2-yl) methylene Diacetate OR 5-Nitro-2-furaldehyde Diacetate

 92-55-7 - - - -
176

5-Nitrofurfural or (5-nitrofuran-2-carbaldehyde) or 5-Nitro-2-furaldehyde

 698-63-5 - - - -
177 Nitrofurazone or 2-[(5-Nitro-2-furyl) methylene] hydrazine carboxamide OR [(E)-(5-nitrofuran-2-yl) methylideneamino]urea 59-87-0 - - - -
ATORVASTATIN CALCIUM*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
178

Atorvastatin-tert-butyl ester ;(3R,5R)-tert-butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxy heptanoate.

 134395-00-9 - - - -
179

Atorvastatin Acetonide tert-Butyl Ester (L1) tert-Butyl (4R,6R)-2-[[[6-(2-4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl) pyrrol-1-yl]ethyl]-2,2-di methyl-1, 3-dioxan-4-yl]acetate or (4r,6r)-6-[2-[2-(4-fluoro phenyl) -5-(1-methyl ethyl) - 3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic acid 1,1-dimethyl ethyl ester or Atorvastatin intermediate L1 or Atorvastatin Acetonide tert-Butyl Ester or Atorvastatin Related Compound-I.

 125971-95-1 - - - -
180

Atorvastatin Impurity-M4 or (2-[2-(4-fluoro-phenyl)-2-oxo-1-phenyl-ethyl]-4-methyl-3-oxo-pentanoicacid phenyl amide (M4) 

 125971-96-2 - - - -
FAVIPIRAVIR*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
181

6-Bromo-3-hydroxypyrazine-2-carboxamide

 259793-88-9 - - - -
182

3,6-Dichloropyrazine-2-carbonitrile

 356783-16-9 - - - -
183

6-fluoro-3-hydroxypyrazine-2-carboxylic acid OR Favipiravir acid impurity

 1079990-21-8 - - - -
184

6-Fluoro-3-hydroxypyrazine-2-carbonitrile dicyclo hexylamine salt

 1137606-74-6 - - - -
ISONIAZID*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
185

Pyridine-4-carboxylic acid or Isonicotinic acid or Isoniacin

 55-22-1 A - - -
186

Pyridine-4-Carboxamide or Isonicotinamide

 1453-82-3 B - - -
187

4-Cynopyridine, Pyidine-4-carbonitrile or Isonicotnonitrile

 100-48-1 C - - -
188 Pyridine-3-carbohydrazine or Nicotinoyl hydrazine 553-53-7 D - - -
189 2-Cynopyridine, Pyidine-2-carbonitrile or Picolinonitrile or 2-Isoniazid 100-70-9 - - - -
190 3-Cynopyridine, Pyidine-3-carbonitrile or 3-Isoniazid 100-54-9 - - - -
191

Pyridine-2-carbohydrazine or Picolino hydrazine

 1452-63-7 - B - -
PARACETAMOL*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
192

Paracetamol Impurity-F or 4-Nitrophenol or p-nitro phenol

 100-02-7 - - - -
193

Paracetamol Impurity-J or 4-chloro acetanilide or  p-chloro acetanilide

 539-03-7 - - - -
194

Paracetamol Impurity-K or 4-aminophenol or  p-amino phenol

 123-30-8 - - - -
ETODOLAC*
Sr. No. Name CAS
No.		 BP
Code		 USP
Code		 EP
Code		 WHO
Code
195 Tryptophol

 526-55-6 - - - -
196 7-Ethyl tryptophol (7-ETP) OR 2-(7-ethyl-1H-indol-3-yl) ethanol

 41340-36-7 - - H -
197 (1RS)-8-ethyl-1-methyl-1,3,4,9-tetrahydropyrano[3,4-b] indol-1-yl] acetic acid (as per EP) OR (+/-)-8-Ethyl-1-methyl-1,3,4,9-tetrahydropyrano [3,4-b]-indole-1-acetic acid (as per USP) OR 1-Methyl etodolac

 109518-47-0 - Related Compd. A C -
198 Methyl [(1RS)-1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b] indol-1-yl] acetate (as per EP) OR Etodolac Methyl Ester

122188-02-7 - - K -
* Standard of API is also available
 

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