IMPURETÉS

N° Sr. Nom N° CAS Code BP Code USP Code EP
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 6994-25-8 - 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 - - -
FUROSEMIDE*
21 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
22 2,4 dichloro-5-Sulphamoyl benzoic acid [Lasamide] 2736-23-4 - - B
23 2-amino-4-chloro-5-Sulphamoyl benzoic acid 3086-91-7 - - C
24 2,4-dichlorobenzoic acid 50-84-0 - - E
25 4-chloro-5-sulfamoylanthranilic acid 3086-91-7 - B -
HYDROXYCHLOROQUINE SULPHATE*
26 4,7-Dichloroquinoline 86-98-6 - - -
LUMEFANTRINE*
27 2,7-dichloro-4-fluorenyl ketone 7012-16-0 - - -
28 2-chloro-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanone - - - -
29 2-dibutylamino-1-(2,7-dichloro-9H-fluoren-4-yl)-ethanol 69759-61-1 - - -
30 4-Chloro benzaldehyde 104-88-1 - - -
NIMESULIDE*
31 N-(2,4-Dinitro-6-phenoxyphenyl)-methanesulphonamide - A - A
32 N-(2-phenoxyphenyl)-methanesulphonamide 51765- 51-6 B - B
33 2-phenoxyaniline 2688-84-8 C - C
34 4-nitro-2-phenoxyphenol 70995-08-3 D - D
35 N,N’-(bis methylsulfonyl)-2-phenoxy aniline - E - E
36 N,N’-(bis methylsulfonyl)-2-phenoxy-4-nitro aniline 51765-72-1 F - F
PIPERAQUINE PHOSPHATE*
37 4,7-Dichloroquinoline 86-98-6 - - -
38 7-chloro-4-piperazinyl quinoline 837-52-5 - - -
39 1,4-bis-(4,7-dichloroquinoline)piperazine - - - -
40 4-Piperazin-7-chloro-quinoline - - A -
41 7-Chloro-4-{4-[3-(piperazin-1-yl)propyl]piperazin-1-yl}quinoline 4039-00-3 - B -
42 5-Chloro-4-(4-{3-[4-(7-chloroquinolin-4-yl)piperazin-1-yl] propyl}piperazin-1-yl)quinoline 918879-09-1 - C -
43 7-Chloroquinolin-4-ol 86-99-7 - D -
44 4,4’-[Piperazine-1,4-diylbis(propane-3,1-diylpiperazine-4,1-diyl)]bis(7-chloroquinoline) 86486-21-7 - E -
45 7-Chloro-4-(4-{3[(7-chloroquinolin-4-yl)oxy]propyl} piperazin-1-yl)quinoline 1233345-93-1 - F -
46 N-(7-Chloroquinolin-4-yl)-N’-{3-[4-(7-chloroquinolin-4-yl) piperazin-1-yl]propyl}ethane-1,2-diamine - - G -
47 4,4’-Piperazine-1,4-diylbis(7-chloroquinoline) - - H -
48 7-Chloro-4-[4-(3-chloropropyl)piperazin-1-yl]quinoline 4038-99-7 - I -
TENOFOVIR DISOPROXIL FUMARATE*
49 [Tenofovir]
(R)-[1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methylphosphonic acid
147127-20-6 - - -
50 [Tenofovir isoproxil monoester]
({[(R) -1-(6-Amino-9H-purin-9-yl) propan-2-yloxy] methyl} (hydroxy) phosphoryloxy) methyl isopropyl carbonate
211364-69-1 - - -
51 [Tenofovir isopropyl isoproxil]
O-(Isopropoxycarbonyloxymethyl)-O-isopropyl-{(R)-[1-(6-amino-9H-purin-9-yl) propan-2-yloxy]}methylphosphonate
1246812-40-7 - - -
52 [Tenofovir disoproxil ethyl ester]
O-(Ethoxycarbonyloxymethyl)-O-(isopropoxycarbonyloxymethyl)-{(R)-[1-(6-amino-9H-purin-9-yl) propan-2-yloxy]}methylphosphonate
- - - -
53 [Tenofovir disoproxil carbamate]
O, O-Bis (isopropoxycarbonyloxymethyl){(R)-1-[(6-isopropoxycarbonyl amino)-9H-purin-9yl] propan-2-yloxy]}methylphosphonate
1244022-54-5 - - -
54 [Tenofovir Disoproxil Related compound-B]
((E)-9-(Prop-1-enyl)-9H-purin-6-amine)
4121-40-8 - - -
55 [Adenine] 9H-purin-6-amine 73-24-5 - - -
56 Desmethyl tenofovir disoproxil OR O,O-Bis (isopropylcarbonyloxymethyl) [(6-amino-9H-purin-9yl)ethyloxy]methyl phosphonate 365417-53-4 - D (As procedure-2) -
 
EMTRICITABINE*
N° Sr. Nom N° CAS Code
BP
Code
USP
Code
EP
Code
OMS
57 cis-5-[4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl]-1,3-oxathiolane-2-carboxylic acid (Emtricitabine acid) 1238210-10-0 - B - A
58 4-Amino-5-fluoropyrimidin-2(1H)-one (Fluoro cytosine) 2022-85-7 - A - E
59 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 - -
60 (2R,5R)-5-Hydroxy-1,3-oxathiolane-2-carboxylic acid (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester (HME) 147126-62-3 - - - -
61 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] uracil (Emtricitabine 5-fluoro uracil analog) 145986-11-4 - E - F
62 (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
63 Benzoic acid, 2-hydroxy-. (salicylic acid) 69-72-7 - f - -
64 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
N° Sr. Nom
CAS
Code
BP
Code
USP
Code
EP
Code
OMS
65 6-Methoxy-8-amino quinoline (Primaquine phosphate impurity-1: Specified unidentified impurity; RRT.-0.24) 90-52-8 - Imp. at RRT.-0.24 - -
66 2,3-Dihydrophthalazine-1,4-dione (Primaquine phosphate impurity-2: Specified unidentified impurity; RRT.-0.29) 1445-69-8 - Imp. at RRT.-0.29 - -
 
EFAVIRENZ*
N° Sr. Nom
CAS
Code
BP
Code
USP
Code
EP
Code
OMS
67 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 - -
68 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
69 NN-Benzyl efavirenz OR (S)-6-chloro-4-(cyclopropylethynyl)-1-(4-methoxybenzyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one 174819-21-7 - I - D
70 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
71 Quinoline analog OR 6-chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline 391860-73-4 - K - F
72 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 - -
73 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 - -
74 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
 
LAMIVUDINE*
N° Sr. Nom
CAS
Code
BP
Code
USP
Code
EP
Code
OMS
75 (2RS, 5RS) -5- (4-aminp-2-oxopyrimidine-1 (2H) -yl) -1,3-oxathiolane-2-carboxylicacid OU impureté acide Lamivudine 173829-09-9 - Spécifié imp.-1 A A
76 4-aminopyrimidin-2 (1H) -un OU cytosine 71-30-7 - - E E
77

Pyrimidine-2,4-(1H, 3H)-dione OU Uracil 1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolane-5-

66-22-8 - - F F
78 yl]pyrimidine-2,4-(1H,3H)-dione OU Lamivudine uridine analogue 145986-07-8 - - J J
79 (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 - - - -
 
* Les normes IPA sont également disponibles