Impurities

Sr. No. Name CAS No. BP Code USP Code EP 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 Ethyl-(E/Z)-3-(2-carbethoxy-2-cyanoethenyl)-amino-1H-pyrazole-4-carboxylate 321571-07-7 - F -
6 3-Amino-4-carboxamide pyrazole hemisulfate (ASP) 27511-79-1 - - -
7 3-Morphololino-2-cyanoacrylamide (MCA) 25229-97-4 - - -
AMODIAQUINE HYDROCHLORIDE*
8 7-chloro-4-(4-hydroxy phenyl amino)-Quinoline - - - -
9 N-{3-[(diethylamino)methyl]-4-hydroxyphenyl}-acetamide - - - -
10 N-(4-hydroxyphenyl)-acetamide [Paracetamol] 8055-08-1 - - -
11 4,7-Dichloroquinoline 86-98-6 - - -
ARTEMETHER*/ARTESUNATE*/DIHYDROARTEMISININ*
12 Artemisinin 63968-64-9 - - -
13 Dihydroartemisinin 81496-81-3 - - -
14 α - Artemether 71939-51-0 - - -
BISOPROLOL FUMARATE*
15 (RS)-1-(4-Hydroxymethylphenoxy)-3-isopropylaminopropan-2-ol 62572-93-4 - - A
16 (RS)-1-Isopropylamino-3-[4-(2-propoxyethoxymethyl)phenoxy] propan-2-ol - - - B
CLOPIDOGREL BISULPHATE*
17 (+) –(S)- a-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine -5(4H)-acetic acid  hydrochloride 144750-42-5 - A -
18 Methyl (+) a-(2-Chlorophenyl)-4,5-dihydrothieno[2,3-c]pyridine -6(7H)-acetate. hydrochloride 144750-52-7 - B -
19 Methyl (-) –(R)-a-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine -5(4H)-acetate. Hydrogen sulfate 120202-71-3 - C -
4,7-DICHLOROQUINOLINE
20 4,5-Dichloroquinoline 21617-18-5 - - -
21 7-Chloro-4-ethoxy quinoline 5448-52-2 - - -
22 5-Chloro-4-hydroxy quinoline - - - -
FUROSEMIDE*
23 2-chloro-4-[(furan-2-ylmethyl)amino]-5-sulphamoyl benzoic acid or
2-chloro-4-N-furfurylamino-5-sulfamoylbenzoic acid
4818-59-1 - A A
24 2,4 dichloro-5-Sulphamoyl benzoic acid [Lasamide] 2736-23-4 - - B
25 2-amino-4-chloro-5-Sulphamoyl benzoic acid 3086-91-7 - - C
26 2,4-dichlorobenzoic acid 50-84-0 - - E
27 4-chloro-5-sulfamoylanthranilic acid 3086-91-7 - B -
HYDROXYCHLOROQUINE SULPHATE*
28 4,7-Dichloroquinoline 86-98-6 - - -
LUMEFANTRINE*
29 2,7-dichloro-4-fluorenyl ketone 7012-16-0 - - -
30 2-chloro-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanone - - - -
31 2-dibutylamino-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanol 69759-61-1 - - -
32 4-Chloro benzaldehyde 104-88-1 - - -
NIMESULIDE*
33 N-(2,4-Dinitro-6-phenoxyphenyl)-methanesulphonamide - A - A
34 N-(2-phenoxyphenyl)-methanesulphonamide 51765- 51-6 B - B
35 2-phenoxyaniline 2688-84-8 C - C
36 4-nitro-2-phenoxyphenol 70995-08-3 D - D
37 N,N’-(bis methylsulfonyl)-2-phenoxy aniline - E - E
38 N,N’-(bis methylsulfonyl)-2-phenoxy-4-nitro aniline 51765-72-1 F - F
PIPERAQUINE PHOSPHATE*
39 4,7-Dichloroquinoline 86-98-6 - - -
40 7-chloro-4-piperazinyl quinoline 837-52-5 - - -
41 1,4-bis-(4,7-dichloroquinoline)piperazine - - - -
42 4-Piperazin-7-chloro-quinoline - - A -
43 7-Chloro-4-{4-[3-(piperazin-1-yl)propyl]piperazin-1-yl}quinoline 4039-00-3 - B -
44 5-Chloro-4-(4-{3-[4-(7-chloroquinolin-4-yl)piperazin-1-yl] propyl}piperazin-1-yl)quinoline 918879-09-1 - C -
45 7-Chloroquinolin-4-ol 86-99-7 - D -
46 4,4’-[Piperazine-1,4-diylbis(propane-3,1-diylpiperazine-4,1-diyl)]bis(7-chloroquinoline). 86486-21-7 - E -
47 7-Chloro-4-(4-{3[(7-chloroquinolin-4-yl)oxy]propyl} piperazin-1-yl)quinoline 1233345-93-1 - F -
48 N-(7-Chloroquinolin-4-yl)-N’-{3-[4-(7-chloroquinolin-4-yl) piperazin-1-yl]propyl}ethane-1,2-diamine - - G -
49 4,4’-Piperazine-1,4-diylbis(7-chloroquinoline) - - H -
50 7-Chloro-4-[4-(3-chloropropyl)piperazin-1-yl]quinoline 4038-99-7 - I -
TENOFOVIR DISOPROXIL FUMARATE*
51 [Tenofovir]
(R)-[1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methylphosphonic acid
147127-20-6 - - -
52 [Tenofovir isoproxil monoester]
({[(R) -1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methyl} (hydroxy) phosphoryloxy) methyl isopropyl carbonate
211364-69-1 - - -
53 [Tenofovir isopropyl isoproxil]
O-(Isopropoxycarbonyloxymethyl)-O-isopropyl-{(R)-[1-(6-amino-9H-purin-9-yl) propan-2-yloxy]}methylphosphonate
1246812-40-7 - - -
54 [Tenofovir disoproxil ethyl ester]
O-(Ethoxycarbonyloxymethyl)-O-(isopropoxycarbonyloxymethyl)-{(R)-[1-(6-amino-9H-purin-9-yl) propan-2-yloxy]}methylphosphonate
- - - -
55 [Tenofovir disoproxil carbamate]
O, O-Bis (isopropoxycarbonyloxymethyl){(R)-1-[(6-isopropoxycarbonyl amino)-9H-purin-9yl] propan-2-yloxy]}methylphosphonate
1244022-54-5 - - -
56 [Tenofovir Disoproxil Related compound-B]
((E)-9-(Prop-1-enyl)-9H-purin-6-amine)
4121-40-8 - - -
57 [Adenine]  9H-purin-6-amine 73-24-5 - - -
58 Desmethyl tenofovir disoproxil OR
O,O-Bis (isopropylcarbonyloxymethyl) [(6-amino-9H-purin-9yl)ethyloxy]methyl phosphonate
365417-53-4 - D (As procedure-2) -
59 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 disoproxil fumarate. - - A -
 
EMTRICITABINE*
Sr. No. Name CAS No. BP
Code
USP
Code
EP
Code
WHO
Code
60 cis-5-[4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl]-1,3-oxathiolane-2-carboxylic acid (Emtricitabine acid) 1238210-10-0 - B - A
61 4-Amino-5-fluoropyrimidin-2(1H)-one (Fluoro cytosine) 2022-85-7 - A - E
62 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 - -
63 (2R,5R)-5-Hydroxy-1,3-oxathiolane-2-carboxylic acid (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester (HME) 147126-62-3 - - - -
64 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] uracil (Emtricitabine 5-fluoro uracil analog) 145986-11-4 - E - F
65 (1) 2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-, (2R-cis)-; OR
(2) (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-cytosine. (Des Fluoro Emtricitabine)
134678-17-4 - D - C
66 Benzoic acid, 2-hydroxy-. (salicylic acid) 69-72-7 - f - -
67 Emtricitabine System Suitability Mixture A (As per USP) OR
Mixture of Emtricitabine (5-Fluoro-1-[(2S,5R)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine)  + Emtricitabine Enantiomer (5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine)+  Emtricitabine 5-epimers OR Emtricitabine Diastereomers [Entricitabine 1st Epimer (5-Fluoro-1-[(2S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine) +Emtricitabine 2nd Epimer (5-Fluoro-1-[(2R,5R)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine)].
Emtricitabine:
Cas no. 143491-57-0 +
Emtricitabine Enantiomer: Cas no. 137530-41-7 +
Emtricitabine 5-epimers (Cas No. n/a)
- A + B (Chiral method Procedure 1) - B + D
(B:
Enantiomer)
and
(D: Diastereomers)
 
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)
-
-
-
-
-
 
EFAVIRENZ*
Sr. No. Name CAS
No.
BP
Code
USP
Code
EP
Code
WHO
Code
75 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 - -
76 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
77 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
78 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
79 Quinoline analog OR  6-chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline 391860-73-4 - K - F
80 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 - -
81 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 - -
82 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
83 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
84 (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
85 4-aminopyrimidin-2(1H)-one OR cytosine 71-30-7 - - E E
86 Pyrimidine-2,4-(1H, 3H)-dione OR Uracil 66-22-8 - - F F
87 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
88 (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
89 tert-butyl ((S)-1-((R)-oxiran-2-yl)-2-phenylethyl)carbamate (Boc Epoxy) 98760-08-8 - - - -
90 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 - - - -
91 (S)-2-((methoxycarbonyl)amino)-3,3-dimethylbutanoic acid ORMethoxycarbonyl-L-tert-Leucine  OR MOC-L-tert-Leucine ORAtazanavir Related compound A 162537-11-3 - - - -
92 1H-benzo[d][1,2,3]triazol-1-ol hydrate (HOBT monohydrate) 123333-53-9 - - - -
93 4-(2-Pyridinyl)benzaldehyde OR Pyridinyl benzaldehyde 127406-56-8 - - - -
94 _tert_-butyl 2-(4-(pyridin-2-yl)benzyl) hydrazinecarboxylate (Boc Hydrazine) 198904-85-7 - - - -
95 (2_S_,3_S_)-1,2-epoxy-3-(Boc-amino)-4-phenyl butane OR (2S,3S)-Boc epoxy OR Boc-epoxy diastereomer impurity 98737-29-2
- - - -
96 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
- - - -
97 1-Ethyl-3-(3-dimethylaminopropyl)carbodiimide  (EDC) 1892-57-5
- - - -
98 1-Ethyl-3-(3-dimethylaminopropyl)carbodiimide Hydrochloride  (EDC.HCl) 25952-53-8 - - - -
99 Racemic mixture (DL) of  Methoxy carbonyl-L-tert-Leucine  OR  Methoxy carbonyl-DL-tert-Leucine - - - - -
100 4-(Pyridin-2-yl)benzoic acid OR 4-(2-Pyridyl)benzoic acidOR  Pyridinyl benzoic acid 4385-62-0 - - - -
101 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, SSR - - - - -
102 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 SSRS - - - - -
103 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 RSRR - - - - -
 
SOFOSBUVIR*
Sr. No. Name CAS
No.
BP
Code
USP
Code
EP
Code
WHO
Code
104 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 - - - -
105 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 - - - -
106 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 - - - -
107 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
108 Sulfanilamide OR 4-aminobenzenesulfonamide 63-74-1 - - - -
109 4, 6-Dichloro-5-methoxy pyrimidine 5018-38-2 - - - -
110 4-amino-N-(6-chloro-5-methoxypyrimide-4-yl) benzenesulfonamide OR 4-Amino-N-(6-chloro-5-methoxy-4-pyrimidinyl) benzenesulfonamide 5018-23-5 - - - -
 
PYRIMETHAMINE*
Sr. No. Name CAS
No.
BP
Code
USP
Code
EP
Code
WHO
Code
111 p-Toluene sulfonic acid monohydrate (PTSA) OR 4-Methylbenzene sulfonic acid 6192-52-5 - - - -
112 (4-Chlorophenyl)acetonitrile (4-CPA) 140-53-4
- - - -
113 2-(4-Chlorophenyl)-3-oxopentanenitrile 55474-40-3 - - - -
114 (4-Chlorophenyl)(2-ethyl-1,3-dioxolan-2-yl)acetonitrile 55474-41-4        
 
TENOFOVIR ALAFENAMIDE HEMIFUMARATE*
Sr. No. Name CAS
No.
BP
Code
USP
Code
EP
Code
WHO
Code
115 (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 - - - -
116 Phenyl hydrogen ((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphonate OR Monophenyl PMPA 379270-35-6
- - - -
117 TAF (PS): (S)-isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate : Diastereomer (PR): (S)-isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate OR Tenofovir Alafenamide Fumarate (R,PS:RSOR Tenofovir Alafenamide Fumarate (PS): Diastereomer (PROR GS-7339 - - - - -
118 (R)-diphenyl (((1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphonate
OR Bisphenyl PMPA
- - - - -
119 Phenol OR Benzenol 108-95-2 - - - -
120 Bis((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)diphosphonic acid
OR PMPA Anhydride
- - - - -
121 P-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)-N-((S)-1-isopropox
y-1-oxopropan-2-yl)phosphonamidic acid OR PMPA monoamidate
- - - - -
122 4-Dimethyl amino pyridine OR Dimethylamino pyiridine 1122-58-3 - - - -
123 (S)-isopropyl 2-(((S)-((((S)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phos
phoryl)amino)propanoate OR TAF Diastereomer 1
- - - - -
124 (S)-2-Aminopropionic acid OR L-α-Aminopropionic acid OR L-Alanine 56-41-7 - - - -
125 (S)-2-Amino-propionic acid isopropyl ester OR L-Alanine isopropyl ester HCl 62062-65-1 - - - -
126 (R)-2-Amino-propionic acid isopropyl ester OR D-Alanine isopropyl ester HCl
39613-92-8 - - - -
127 Tenofovir Alafenamide System Suitability Mixture OR Tenofovir Alafenamide
(Ps): Diastereomer (PR)
- - - - -
 
* Standard of API is also available