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ALBANDAZOLE Impurity D H
N
(albendazole-2-amino NH2
sulfone) O N
S
H3C
O
H2N OH
D D
P O Na
HO
O
AMIODARONE-B
CH3
O
I
O NH
I CH3
H2N
H2N
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List of API molecules and their Impurities
CH2
HO N O
H
OH
phenyl)acetoyloxy)acetic acid O
NH
Cl Cl
Cl Cl
Cl Cl
Cl Cl
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List of API molecules and their Impurities
O
(methyl ester of dichlorophenyl)amino]phenyl]acetyl]oxy]ac O
NH
aceclofenac) etate Cl Cl
O
(ethyl ester of dichlorophenyl)amino]phenyl]acetyl]oxy]ac
O
aceclofenac) etate Cl
NH
Cl
ALFUZOSIN 81403-68-1
O H O
HYDROCHLORIDE N N
H HCl
O O
and enantiomer
NH2
NH2
NH2
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List of API molecules and their Impurities
H
AMLODIPINE BESILATE 111470-99-6 N NH2
O
SO3H
O O
H
O O
Cl
H
AMLODIPINE Impurity E 140171-65-9 diethyl 2-((2-aminoethoxy)methyl)-4-(2- N NH2
O
chlorophenyl)-1,4-dihydro-6- O O
methylpyridine-3,5-dicarboxylate O O
Cl
H
AMLODIPINE Impurity F 140171-66-0 dimethyl 2-((2-aminoethoxy)methyl)-4-(2- N NH2
O
chlorophenyl)-1,4-dihydro-6- O O
methylpyridine-3,5-dicarboxylate O O
Cl
O O
Cl
yl]methoxy]ethyl]carbamoyl]benzoic acid Cl
H
AMOXICILLIN 61336-70-7 O COONa
N
TRIHYDRATE H2N HN S
H H H
O
HO
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List of API molecules and their Impurities
dioxopiperazin-2-yl]-5,5- H HN
N
S
dimethylthiazolidine-4-carboxylicacid
N
H
HO
H NH2 H N
N S
H H
O
N O
H
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List of API molecules and their Impurities
H2N
H2N
H2N
H2N
phenyene)]diacetamide H2N NH 2
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List of API molecules and their Impurities
Atorvastatin WS (3R,5R)-7-(3-(phenylcarbamoyl)-5-(4- F
fluorophenyl)-2-isopropyl-4-phenyl-1H-
OH OH O
pyrrol-1-yl)-3,5-dihydroxyheptanoic acid H
N
N (R) (R)
+2
O Ca
Ph
O
tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- O
yl)ethyl)-2-isopropyl-N,4-diphenyl-1H- N
O
(R)
(R)
pyrrole-3-carboxamide HN
OH
Ph O
(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-
OH OH O
pyrrol-1-yl)-3,5-dihydroxyheptanoate H N O
N
Ph
O
Atorvastatin Amide F
OH OH O OH OH O
H N N O)Ca +2
N H
Ph
O
fluorophenyl)-2-isopropyl-4-phenyl-1H-
pyrrol-1-yl)-3,5-dihydroxyheptanoic acid H N
OH OH O
+2
N (S) (S) O Ca
Ph
O
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List of API molecules and their Impurities
(R) (R)
+2
N N O Ca
Ph
O
(phenylcarbamoyl)-5-(4-fluorophenyl)-2- O O O
isopropyl-4-phenyl-1H-pyrrol-1-yl)ethyl)- N O
2,2-dimethyl-1,3-dioxan-4-yl)acetate HN
Ph O
fluorophenyl)-2-isopropyl-4-phenyl-1H-
O O O
pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- N OH
4-yl)acetic acid
HN
Ph O
5-(4-fluorophenyl)-2-isopropyl-4-phenyl-
OH OH O
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate N O
HN
Ph O
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List of API molecules and their Impurities
5-(4-fluorophenyl)-2-isopropyl-4-phenyl- OH OH O
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid N
OH
HN
O
OH
(3R,5R)-7-(3-(4-hydroxyphenylcarbamoyl)-
F
P-Hydroxy Atorvastatin
5-(4-fluorophenyl)-2-isopropyl-4-phenyl- OH OH O
N
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid HN
OH
HO
O
Lactone tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- O
yl)ethyl)-N-(2-hydroxyphenyl)-2-isopropyl- N (R)
(R)
OH
4-phenyl-1H-pyrrole-3-carboxamide HN
O
OH
O
Lactone tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- O
(R)
yl)ethyl)-N-(4-hydroxyphenyl)-2-isopropyl- N (R)
OH
4-phenyl-1H-pyrrole-3-carboxamide HN
O
phenylethylidene)-4-methyl-3-oxo-N-
phenylpentanamide O
(E) O
HN
Ph O
O
O
N OH
HN O
Ph O
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List of API molecules and their Impurities
diphenylfuran-3-carboxamide
O
HN
Ph O
O
BALSALAZIDE IMPURITY HN
B O OH HO
N
N
O N
NH
OH
BALSALAZIDE IMPURITY C
N N NH2 N
O
N H 2
O
BECLOMETASONE 5534-09-8
O O
DIPROPIONATE HO
H CH 3 O O
CH 3
H3C H CH 3
H
Cl
O
O
BECLOMETASONE 69224-79-9 9-chloro-11 beta,17-dihydroxy-16 beta- O O
Impurity A methyl-3,20-dioxopregna-1,4-dien-21-yl HO OH
Impurity H methyl-3,20-dioxopregna-1,4-dien-17-yl HO O
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List of API molecules and their Impurities
O O
yl)methyl)phenol
N
BUDESONIDE 51333-22-3 O OH
O
HO
O
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List of API molecules and their Impurities
beta,21-dihydroxypregna-1,4-diene-3,20- HO
O
O
dione
O
beta-hydroxy-3,20-dioxopregna-1,4-dien- HO
O
O
21-al
O
CLARITHROMYCIN
CH3
CH3 O
CH3 CH3
H3C
H3C N
O CH3
HO OH O HO
HO O O
CH3 CH3
CH3 H3C O
O
OH
CH3
Cl S
CLOPIDOGREL methyl (2-chlorophenyl)(4,7- O O
IMPURITY-B dihydrothieno[2,3-c]pyridin-6(5H)-
N S
yl)acetate
Cl
NH2
CPP LYSINE 6-amino-2-[(1-carboxy-3-
phenylpropyl)amino]hexanoic acid O OH
O
NH
OH
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HYDROCHLOROTHIAZI H2N
O OO
S S
DE IMP NH
O
A(CHLOROTHIAZIDE)
Cl N
CAPTOPRIL 62571-86-2 O
H COOH
N
HS
H
HO
CARVEDILOL 72596-09-3 1-(2-(2-methoxyphenoxy)ethylamino)-3- H
N
O O
(9H-carbazol-4-yloxy)propan-2-ol O
HN
yloxy)-1-(3-(9H-carbazol-4-yloxy)-2- OH
O
O N
hydroxypropyl)piperidin-3-ol O
O
HN
HN
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List of API molecules and their Impurities
N OH
DIHYDROCHLORIDE chlorophenyl)(phenyl)methyl)piperazin-1- N
yl)ethoxy)acetic acid .2HCl .2HCl
phenylethyl)piperazin-1-yl)ethoxy)acetic N OH
N
acid Cl
phenylethyl)piperazin-1- N O
yl)ethoxy)ethoxy)acetic acid
CETIRIZINE N-OXIDE Cl
O
O
O
N OH
N
H
CHLORPHENAMINE 113-92-8 Cl O
MALEATE N OH
OH
N
O
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List of API molecules and their Impurities
N N
Cl
Cl
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List of API molecules and their Impurities
carbonitrile hydrobromide
O N
F
CITALOPRAM IMPURITY A (R)-1-(3-(dimethylamino)propyl)-1-(4-
fluorophenyl)-1,3-dihydroisobenzofuran-5-
carboxamide
O N
H2N
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List of API molecules and their Impurities
fluorophenyl)-1,3-dihydro-3-
hydroxyisobenzofuran-5-carbonitrile
O N
NC
OH
fluorophenyl)-1,3-dihydro-3-
oxoisobenzofuran-5-carbonitrile
O N
NC O
(methylamino)propyl)isobenzofuran-5-
carbonitrile
O NH
NC
dihydroisobenzofuran-1-yl)-N,N-
dimethylpropan-1-amine
O N
Br
(dimethylamino)propyl)-1-(4-fluorophenyl)- N
1,3-dihydroisobenzofuran-5-yl)butan-1-one
O N
Cl
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List of API molecules and their Impurities
A chlorophenyl)methanone O
O2N
Cl
H
Clonazepam Impurity B 3-amino-4-(2-chlorophenyl)-6- N O
nitroquinolin-2(1H)-one
O2N NH2
Cl
Clozapine 5786-21-0 Cl
N
N N
HN
Cl
Clozapine Impurity B 263366-81-0 11,11-(Piperazine-1,4-diyl)bis(8-chloro-
5Hdibenzo b,e 1,4-diazepine N
HN N N NH
N
Cl
1,4 diazepine N
N
Cl
N
H
chlorophenylamino)phenyl)(4- NH O
methylpiperazin-1-yl)methanone N
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List of API molecules and their Impurities
Cyclobenzaprine n-oxide
N
O
Cyproheptadine 963-35-5
Hydrochloride
N
OH
HO OH
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OH
yl}-(2-hydroxy-ethyl)-amino]-ethanol NN
N
N
HO OH
benzo[e][1,4]diazepin-2(3H)-one
Cl N
(USP) chlorophenyl)(phenyl)methanone Cl O
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Diphenhydramine 147-24-0
Hydrochloride
N
O
HCl
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List of API molecules and their Impurities
oxobenzo[d]imidazol-3-yl)piperidin-1- N N N N
N
Cl
yl)propyl)-1H- Cl O
benzo[d]imidazol-2(3H)-one
Doxorubicin 25316-40-9 O OH
O
OH
Hydrochloride OH
HCl
OMe O OH H
O
O
OH
NH2
OMe O OH H OH
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Doxylamine Succinate O
OH
N
N O OH
OH
N
(R)-Alanine CH3
NH
HO
N-[1-(S)-Ethoxy carbonyl-3-cyclohexyl O O
CH3O
propyl]-(S)-Alanine NH
OH
H H
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O O
NH O
H H O HO
O OH
S)-1-[N-[1-Ethoxy carbonyl-3-cyclohexyl
O
HO
OH
propyl]-L-Alaninyl]-L-proline, (Z)-2-
Estrone Sulphate D4 CH3 O
D
H D
D
H H
HO
H
H H
H H
O
O S OOH
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List of API molecules and their Impurities
O
ETOFENAMATE 30544-47-9 2-(2-hydroxyethoxy)ethyl 2-(3- O
O OH
(trifluoromethyl)phenylamino)benzoate NH
F
F F
F
F F
Famciclovir A [4-(2-amino-9H-purin-9-yl)-2- N N
N
(hydroxymethyl)butyl acetate] H2N N
OH
O
H3C
O
Cl
Famciclovir B [4-(2-amino-6-chloro-9H-purin-9-yl)butyl N N
acetate] H 2N N N
O
O
CH3
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List of API molecules and their Impurities
Na+
Fosinopril cyclohexyl L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1- O-
O
analogue oxopropoxy) propoxy](4-cyclohexyl O
P
butyl)phosphonyl]acetyl]-sodium salt H3C O O
CH3
H3C O
O
O
Fosinoprilate O
OH O O-
O O
P
O
O
O OH
FAMOTIDINE Impurity B 109467-08-5 3,5-Bis[2-[[[2-[(diaminomethylene)amino]- N
S
N H2N
NH2 NH2
thiazol-4-yl]methyl]sulphanyl]-4H-1,2,4,6- H2N
N
N S N
H
S
N
O S
S
OH
2
OH
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List of API molecules and their Impurities
FENOFIBRATE 49562-28-9 O
Cl O
O
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List of API molecules and their Impurities
HCl
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FLUCLOXACILLIN [3-(2-chloro-6-fluorophenyl)-5- Cl
H COOH
Impurity A methylisoxazol-4-y F HN
CH3
N H
carbonyle]amino]methyl]-5,5- O
N
S CH 3
O
dimethyl;thioazolidine-4-carboxylic CH 3 HOOC
acid(penicilloic acids of flucloxacillin
FLUCLOXACILLIN sodium (2S,5R,6R)-6-amino-3,3-dimethyl-7- O
H COONa
Impurity C oxo-4-thia-1-aza-bicyclo[3.2.0]heptane-2- N CH3
carboxylate H2N S CH3
H H
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FLURBIPROFEN 5104-49-4
F OH
Glibenclamide 10238-21-8 O O
S
O N N
O H H
Cl
N
H
OMe
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List of API molecules and their Impurities
GLICLAZIDE 21187-98-4
O O
S N
N N
O H H
H H O
Glipizide 29094-61-9 N N
S
O
O O
N
N
H
N
H H O
Glipizide impurity C 13554-93-3 Ethyl [2-[4-[(cyclohexylcarbamoyl)- N N
S
sulphamoyl]phenyl]ethyl]carbamate O
O O
N O
H
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List of API molecules and their Impurities
GUAIFENESIN 93-14-1 OH
O OH
compound C CH 3
H3C
CH 3
OH
H3C
H 3C
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List of API molecules and their Impurities
yl)(phenyl)methanone
N
OH
Ketrolac Impurity B O
5-(phenylcarbonyl)-2,3-dihydro-1H-
pyrrolizin-1-one N
Ketoprofen 22071-15-4 H CH
3
OH
O
and enantiomer
O
O
and enantiomer
H
H OH
OH
H CH 3
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List of API molecules and their Impurities
Oxide N
O O
N
O
F
F
F
Lisinopril cyclohexyl NH 2
analogue O OH
O
NH
O
N
OH
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List of API molecules and their Impurities
O
OH
Lisinopril RS
NH2
O OH
O
NH
O
N
OH
N
benzo[5,6]cyclohepta[1,2-b]pyridin-11-
ylidene)piperidine-1-carbaldehyde N
Cl
Cl
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List of API molecules and their Impurities
Cl
Lacidipine 103890-78-4
O
O
O O
HN O
butoxycarbonyl)vinyl]phenyl}-2,6-
O O
dimethylpyridine-3,5- dicarboxylate
N O
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List of API molecules and their Impurities
(trifluoromethyl)phenyl]but-2-enamide H
N
(Teriflunomide) OH O
F
F
F
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List of API molecules and their Impurities
Cl
Loperamide 34552-83-5 OH
Hydrochloride N HCl
Cl
Loperamide Impurity H 61299-42-1 4-[4-(4-chlorophenyl)-3,6-dihydropyridin-
1(2H)-
yl]-N,N-dimethyl-2,2-diphenylbutanamide N
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List of API molecules and their Impurities
Loratadine 79794-75-5 Cl O
N O
benzo[5,6]cyclohepta[1,2-b ]pyridin-11- N O
ylidene)piperidine-1-carboxylate N
Cl
Mesalamine N-acetyl O
HO
O OH
Metoprolol impurity-E HO O
[2-(2-methoxyethyl)phenoxy][(1- O
NH
methylethyl)amino]methanol
H3C NH OH
CH3
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List of API molecules and their Impurities
methylethyl)amino]propan-2-ol OH
NH
O
HO
H O
N
N
N
O O H
1,3-bis[(1-methylethyl)amino]propan-2-ol OH
H3C NH NH CH3
CH3 CH3
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List of API molecules and their Impurities
O 2
OH O
HO
OH
O OH
HO
N
METRONIDAZOLE 5006-69-9 2-(4-nitro-1H-imidazol-1-yl)ethanol OH
Impurity C
N
O2 N N
METRONIDAZOLE 16156-94-8 2-(2-(2-methyl-5-nitro-1H-imidazol-1- OH
O
Impurity F yl)ethoxy)ethanol
O2N
N
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List of API molecules and their Impurities
dichlorophenyl)ethyl)-1H-
imidazole O
N
Cl H Cl Cl
and enantiomer.HNO3
N
dichlorophenyl)ethanamine
Cl
H
O
NH 2 and enantiomer
Cl Cl
MINOXIDIL 38304-91-5
N N NH2
N
O
NH2
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List of API molecules and their Impurities
MIRTAZAPINE 85650-52-8
N
N
c][2]benzazepine N N O
NH CH3
HO
Monteleukast Z-isomer 2-(1-(((R)-1-(3-((Z)-2-(7-chloroquinolin-2- O
yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2- (Z)
S H
yl)phenyl)propyl)sulfanyl)cyclopropyl)acetic (R)
N
acid HO
Cl
enoate CH 3
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List of API molecules and their Impurities
dihydroisobenzofuran-5-yl)- O
O O
4-methylhex-4-enoate N-oxide
O
Niacin metabolite N-methyl-2-pyridone-5-carboxamide
NH2
O N
CH3
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List of API molecules and their Impurities
Nordiphenhydramine 2-(diphenylmethoxy)-N-
methylethanamine
O
NH
CH3
Naproxen 22204-53-1 O
OH
NEVIRAPINE 129618-40-2
N N N
NH
O
NH
O
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List of API molecules and their Impurities
NH
Nimesulide O2N
O O NH
S
O
-O N+
O
phenoxyaniline
O
OO N S
S O
O
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List of API molecules and their Impurities
O N+
O-
Nortriptyline 894-71-3
HCl
Hydrochloride N
H
HO
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List of API molecules and their Impurities
OH OH
Nebivolol 99200-09-.6 H
O N O
F F
F F
methylpiperazin-1-yl)-2-
N
thioxobenzo[b][1,4]diazepin-3- N
ylidene)propan-2-one
N
H S O
Olanzapine-d3 2-methyl-4-[4-(2H3)methylpiperazin-1-yl]- H 3C
D
N
D
D
10H-thieno[2,3-b][1,5]benzodiazepine S N
HN N
Omeprazole N-oxide H
O
CH3
O H3C
N
S CH3
H3C
O N
N
Omeprazole sulfone N- O
CH3
H O H3C
oxide N
S
CH3
H3C
O N
O N
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List of API molecules and their Impurities
N
hydroxycyclohexyl)ethyl]phenol CH3
OH
OH
Omeprazole 73590-58-6 O
H
N
S
O N O
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List of API molecules and their Impurities
Ondansetron 103639-04-9
N N HCl
Hydrochloride Dihydrate
N 2 H2O
Orphenadrine 341-69-5
Hydrochloride
H
N
O
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List of API molecules and their Impurities
methylphenyl)phenylmethoxy]ethanamine
H
(meta-methyl O
N
Hbezyl isomer)
Pravastatin HO O
CH3
HO
OH
HO
O
H3C O
CH3
CH3
OH
dimethoxy-2-pyridinyl)methyl] sulfonyl]- O NH
O
1H-benzimidazole O
N
F
S F
N
O
Pantoprazole Sulfone N- H
N O
F
Oxide S O CH3
F O NO
N O
O
CH3
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List of API molecules and their Impurities
78246-49-8 F
Paroxetine Hydrochloride
(anhydrous)
O O NH.HCl
yloxy)methyl]-1- benzyl-4-(4-
O
fluorophenyl)piperidine hydrochloride (N- O N
benzyl paroxetine) O
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List of API molecules and their Impurities
Pindolol 13523-86-9 HO
H
HN O N
Piroxicam 36322-90-4 O O
S
N
H
N N
OH O
OH O
O N
N N
O HCl
O N
H2N
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List of API molecules and their Impurities
Prazosin Hydrochloride O
O N
N N
O HCl
O N
H2N
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List of API molecules and their Impurities
6,7-dimethoxy-2-(piperazin-1-yl)- O NH
N
Prazosin Impurity C quinazolin-4- N
amine O N
H2N
PROMETHAZINE N,N-dimethyl-1-(10H-phenothiazin-10-
yl)propan-2-amine hydrochloride N N
S HCl
Propranolol OH
H
Hydrochloride O N HCl
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List of API molecules and their Impurities
Quetiapine sulfoxide N
O OH
N
N
HO S
7-hydroxylated S
quetiapine
HO
N
N
N
O OH
OH
Ramipril hydrate O
CH3
O
NH
N
HO
H3C
Ramipril(RS) O O
H3C
O
NH
N
HO
O
H H
H HCl
HO N
O
H
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List of API molecules and their Impurities
compound 1,4dioxodecahydro-2H- O
N
H
cyclopenta[4,5]pyrrole[1,2-a] pyrazin-2-yl]- H H
N
4-phenyl butanoate O
N-(2-((5-((dimethylamino)methyl)furan-2- H3C
RANITIDINE N NO2
HYDROCHLORIDE yl)methylthio)ethyl)-N-methyl-2- H3C
O
CH3
nitroethene-1,1-diamine hydrochloride S
N
N
H H
HCl
Cl HN
CH3
sildenafil (N-desmethyl O
sildenafil) OO HN
N
N
S
N
N
HN CH3
O CH3
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List of API molecules and their Impurities
CH3 OH OH
H OH
H
O O
CH3
H3C
H3C
CH3
H3C
Simvastatin Acetate O O
Impurity B H3C
O
H3C CH3 O
CH3
H3C
O
Simvastatin anhydro
O
Impurity C H3C
H3C CH3 O
CH3
H3C
HO
Simvastatin impurity D O
O O
(Lovastatin) H3C
O
H 3 C CH 3
CH3
H3C
Sertraline Hydrochloride HN
HCl
C
Cl l
CH3
Sertraline Impurity A (+/-)-trans-4-(3,4-dichlorophenyl)-1,2,3,4- HN H
tetrahydro-N -methyl-1-naphthalenamine
H
Cl
Cl
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List of API molecules and their Impurities
tetrahydronaphthalen-1-amine
naphthalenone (tetralone)
H
Cl
Cl
- methyl-1-naphthalenamine
((1R,4R)enantiomer) H
Cl
Cl
Sertralone
H
Cl
Cl
Serteraline
H
Cl
Cl
H
Cl
Cl
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List of API molecules and their Impurities
H
Cl
Cl
Sulfaguanidine OO NH
S
N NH2
H
H2N
Sulfamethoxazole
O O O
S
N N
H
H2N
Sulfamethoxazole N-[4-[(5-methylisoxazol-3-yl)- H O
N
Impurity A sulphamoyl]phenyl]acetamide S
O
ON O
N
H
NH CH3
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List of API molecules and their Impurities
H3C
Trandolapril cyclohexyl O
OH
analogue O
O
CH
3
N
NH
HO
Trandolapril Diketo O
analougue
CH3
O O
N H
Trandolaprilate
HO
O
NH
H 3C
O
H
N O
OH
H
Tamoxifen Citrate
O OH OH
O O .N
O
HO OH
Terbinafine (E)-N,6,6-trimethyl-N-((naphthalen-1- H
Hydrochloride yl)methyl)hept-2-en-4-yn-1-amine Cl
N
hydrochloride
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List of API molecules and their Impurities
Ticlopidine S
Hydrochloride N HCL
HN
S
Trimipramine Maleate
N N COOH
COOH
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List of API molecules and their Impurities
N
hydroxycyclohexyl)ethyl]phenol CH3
OH
OH
Venlafaxine 1-(2-(dimethylamino)-1-(4-
OH
Hydrochloride methoxyphenyl)ethyl)cyclohexanol
N
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List of API molecules and their Impurities
Zidovudine 1-((2R,4R,5S)-4-azido-tetrahydro-5- O
HN
(hydroxymethyl)furan-2-yl)-5- HO O N
methylpyrimidine-2,4(1H,3H)-dione O
N3
Cl
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