ALLENDRONATE d6 di disodium [4 -amino -1-hydroxy(2H6

64 Pages·2010·0.61 MB·English

List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

ALBENDAZOLE SULFONE methyl 5-(propylsulfonyl)-1H- H
N
benzo[d]imidazol-2-ylcarbamate
NH
O
S N O
H3C O O CH3
ALBANDAZOLE Impurity D H
N
(albendazole-2-amino –
NH
O 2
sulfone) S N
H C
3 O
ALLENDRONATE d6 di disodium [4-amino-1-hydroxy(2H6)butane- O
sodium salt 1,1-diyl]bis[hydrogen (phosphonate)] D D D DHO P ONa
H2N OH
D D
HO P ONa
O
AMIODARONE-B CH3
O
O
I
I O NH CH3
ATENOLOL IMPURITY A 2-(4-hydroxyphenyl)acetamide OH
O
H N
2
ATENOLOL IMPURITY B 2-[4-(oxiran-2-ylmethoxy)phenyl]acetamide
O O
O
H N
2
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

ATROPIC ACID 2-phenyl-2-propanoic acid O
OH
CH
2
ASPARTAME RELATED (5-benzyl-3,6-dioxo-2-piperazine acetic H
O N
COMPOUND acid) O
HO N O
H
ACECLOFENAC 89796-99-6 2-(2-(2-(2,6-dichlorophenylamino) O
phenyl)acetoyloxy)acetic acid O OH
O
NH
Cl Cl

ACECLOFENAC Impurity A 2-(2-(2,6-dichlorophenylamino) OH
(diclofenac) phenyl)acetic acid O
NH

Cl Cl

ACECLOFENAC Impurity B methyl 2-(2-(2,6- O
(diclofenac methyl ester) dichlorophenylamino)phenyl)acetate O
NH
Cl Cl

ACECLOFENAC Impurity C ethyl 2-(2-(2,6- O
(diclofenac ethyl ester) dichlorophenylamino)phenyl)acetate O
NH
Cl Cl
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

ACECLOFENAC Impurity D methyl[[[2-[(2,6- O
O
(methyl ester of dichlorophenyl)amino]phenyl]acetyl]oxy]ac O
O
aceclofenac) etate NH
Cl Cl

ACECLOFENAC Impurity E ethyl[[[2-[(2,6- O
O
(ethyl ester of dichlorophenyl)amino]phenyl]acetyl]oxy]ac O
O
aceclofenac) etate NH
Cl Cl

ALFUZOSIN 81403-68-1
HYDROCHLORIDE O N HN O HCl
H
O
O
and enantiomer
NH
2
ALFUZOSIN Impurity A 98902-29-5 N-[3-[4-amino-6,7-dimethoxy-quinazolin-2-
H
yl)methylamino]propyl]furan-2- O N N N O
carboxamide N O
O
NH2
ALFUZOSIN Impurity C 72104-34-8 N-(3-(4-amino-6,7-dimethoxyquinazolin-2-
H
ylamino)propyl)-tetrahydro-N-methylfuran- O N N N O
2-carboxamide N O
O
NH2
ALFUZOSIN Impurity E N-[3-[(4-amino-6,7-dimethoxyquinazolin-2- H
O N N N H
yl)methylamino]propyl]formamide
N O
O
NH2
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

AMLODIPINE BESILATE 111470-99-6 H
N O NH2 SO3H
O O
H
O O
Cl

AMLODIPINE Impurity E 140171-65-9 diethyl 2-((2-aminoethoxy)methyl)-4-(2- H
chlorophenyl)-1,4-dihydro-6- N O NH2
O O
methylpyridine-3,5-dicarboxylate
O O
Cl

AMLODIPINE Impurity F 140171-66-0 dimethyl 2-((2-aminoethoxy)methyl)-4-(2- H
chlorophenyl)-1,4-dihydro-6- N O NH2
O O
methylpyridine-3,5-dicarboxylate
O O
Cl

AMLODIPINE Impurity G 43067-01-2 dimethyl 4-(2-chlorophenyl)-1,4-dihydro- H
N
2,6-dimethylpyridine-3,5-dicarboxylate
O O
O O
Cl

AMLODIPINE Impurity H 318465-73-5 2-[[2-[[(4R)-4-(2-Chlorophenyl)-3-
H H
(ethoxycarbonyl)-5-(methoxycarbonyl)-6- N O N
O O O
methyl-1,4-dihydropyridin-2- O OH
O O
yl]methoxy]ethyl]carbamoyl]benzoic acid Cl

AMOXICILLIN 61336-70-7 H
O COONa
TRIHYDRATE N
H2N HN S
H HH
O

HO
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

AMOXICILLIN Impurity C 4S)-2-[5-(4-Hydroxyphenyl)-3,6- H
COOH
dioxopiperazin-2-yl]-5,5- H HN
N
dimethylthiazolidine-4-carboxylicacid S
N
H
HO
AMOXICILLIN Impurity D (2R)-2-amino-2-(4- H
COOH
hydroxyphenyl)acetyl]amino]carboxymethy H NH2H HN
N
l]-5,5-dimethylthiazolidine-4-carboxylicacid
S
O COOH
HO
AMPICILLIN TRIHYDRATE 7177-48-2 H COOH
O

H NH2H N
N
S
H H
O
AMPICILLIN Impurity C (4S)-2-(3,6-dioxo-5-phenylpiperazin-2-yl)- H
COOH
5,5-dimethylthiazolidine-4-carboxylic acid H HN
O N
S
N O
H

AMPICILLIN Impurity D (4S)-2-[[[(2R)-2-amino-2- H
COOH
phenylacetyl]amino]carboxymethyl]-5,5- H NH2H HN
N
dimethylthiazolidine-4-carboxylic acid
S
O COOH

ATENOLOL 29122-68-7 2-(4-((R)-2-hydroxy-3- H OHH
(isopropylamino)propoxy)phenyl)acetamid O N
O
e
H2N and enantiomer
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

Atenolol Impurity A 2-(4-hydroxyphenyl)acetamide OH
O
H2N
Atenolol Impurity B 2-(4-((oxiran-2-
O O
yl)methoxy)phenyl)acetamide O
H2N
Atenolol Impurity C 2-(4-(2,3- OH
dihydroxypropoxy)phenyl)acetamide O OH
O
H2N
Atenolol Impurity D 2-(4-(3-chloro-2- OH
hydroxypropoxy)phenyl)acetamide O Cl
O
HN
2
ATENOLOL Impurity F 87619-83-8 2,2-[(1-methylethyl)-iminobis(2- OH OH
hydroxypropan-3,1-diyloxy-4,1- O O N O O
phenyene)]diacetamide H2N NH2
ATENOLOL Impurity G 56392-14-4 2-(4-((R)-2-hydroxy-3- H OHH
(isopropylamino)propoxy)phenyl)acetic O N
O
acid
HO
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

Atorvastatin WS (3R,5R)-7-(3-(phenylcarbamoyl)-5-(4-
F
fluorophenyl)-2-isopropyl-4-phenyl-1H-
pyrrol-1-yl)-3,5-dihydroxyheptanoic acid OH OH O
HN N (R) (R) O Ca+2
Ph
O

Atorvastatin Lactone 5-(4-fluorophenyl)-1-(2-((2R,4R)- F
tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
O
yl)ethyl)-2-isopropyl-N,4-diphenyl-1H- O
N (R)
pyrrole-3-carboxamide (R)
OH
HN
Ph O
Atorvastatin Methyl ester (3R,5R)-methyl 7-(3-(phenylcarbamoyl)-5- F
(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-
pyrrol-1-yl)-3,5-dihydroxyheptanoate OH OH O
HN N O
Ph
O
Atorvastatin Amide F
OH OH O OH OH O
PhHN N NH O)Ca+2
O
Atorvastatin isomer (3S, 5S) (3S,5S)-7-(3-(phenylcarbamoyl)-5-(4-
F
fluorophenyl)-2-isopropyl-4-phenyl-1H-
pyrrol-1-yl)-3,5-dihydroxyheptanoic acid OH OH O
HN N (S) (S) O Ca+2
Ph
O

Atorvastatin Diastereomer (3S,5R)-7-(3-(phenylcarbamoyl)-5-(4-
F
(3S, 5R) fluorophenyl)-2-isopropyl-4-phenyl-1H-
pyrrol-1-yl)-3,5-dihydroxyheptanoic acid OH OH O
HN N (R) (S) O Ca+2
Ph
O
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

Desfluoro Atorvastatin (3R,5R)-7-(3-(phenylcarbamoyl)-2-
isopropyl-4,5-diphenyl-1H-pyrrol-1-yl)-3,5-
dihydroxyheptanoic acid OH OH O
HN N (R) (R) O Ca+2
Ph
O

3-O-methyl Atorvastatin (3R,5R)-7-(3-(phenylcarbamoyl)-2-
isopropyl-4,5-diphenyl-1H-pyrrol-1-yl)-5-
hydroxy-3-methoxyheptanoic acid OH O O
HN N (R) (R) O Ca+2
Ph
O

5-O-methyl Atorvastatin (3R,5R)-7-(3-(phenylcarbamoyl)-2-
isopropyl-4,5-diphenyl-1H-pyrrol-1-yl)-3-
hydroxy-5-methoxyheptanoic acid O OH O
HN N (R) (R) O Ca+2
Ph
O

Atorvastatin L1 tert-butyl 2-((4R,6R)-6-(2-(3- F
(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
Atorvastatin Acetonide 2-((4R,6R)-6-(2-(3-(phenylcarbamoyl)-5-(4- F
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
Atorvastatin t-Butyl ester (3R,5R)-tert-butyl 7-(3-(phenylcarbamoyl)- F
5-(4-fluorophenyl)-2-isopropyl-4-phenyl-
OH OH O
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate
N O
HN

Ph O
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

O-Hydroxy Atorvastatin (3R,5R)-7-(3-(2-hydroxyphenylcarbamoyl)- F
5-(4-fluorophenyl)-2-isopropyl-4-phenyl-
OH OH O
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid
N
OH
HN
O
OH
P-Hydroxy Atorvastatin (3R,5R)-7-(3-(4-hydroxyphenylcarbamoyl)- F
5-(4-fluorophenyl)-2-isopropyl-4-phenyl-
OH OH O
1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid N OH
HN
O

HO
O-Hydroxy Atorvastatin 5-(4-fluorophenyl)-1-(2-((2R,4R)- F
Lactone tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- O
O
yl)ethyl)-N-(2-hydroxyphenyl)-2-isopropyl- N (R) (R) OH
4-phenyl-1H-pyrrole-3-carboxamide
HN
O
OH
P-Hydroxy Atorvastatin 5-(4-fluorophenyl)-1-(2-((2R,4R)- F
Lactone tetrahydro-4-hydroxy-6-oxo-2H-pyran-2- O
O
yl)ethyl)-N-(4-hydroxyphenyl)-2-isopropyl- N (R) (R) OH
4-phenyl-1H-pyrrole-3-carboxamide HN
O

ATS diketoene (E)-2-(2-(4-fluorophenyl)-2-oxo-1- F
phenylethylidene)-4-methyl-3-oxo-N-
phenylpentanamide
O
(E) O
HN
Ph O
ATS diepoxide lactone F
O
O
O
N OH
PhHN OO
List of API molecules and their Impurities
Drug Name, EP Impurity CAS No Chemical Name Structure

ATS impurity 5-(4-fluorophenyl)-2-isopropyl-N,4- F
diphenylfuran-3-carboxamide
O
HN
Ph O
BALSALAZIDE IMPURITY O
HN
B NN
O OH HO N
O N
O
NH
O
OH
BALSALAZIDE IMPURITY C
N N NH
2
N
O
NH2
BECLOMETASONE 5534-09-8 O
DIPROPIONATE O O
HOH CH3 O O
H3C H CH3 CH3
H
Cl
O
BECLOMETASONE 69224-79-9 9-chloro-11 beta,17-dihydroxy-16 beta- O
Impurity A methyl-3,20-dioxopregna-1,4-dien-21-yl O O
HO OH
propanoate
(beclometasone 21-
propinate) Cl
O
BECLOMETASONE 5534-18-9 9-chloro-11 beta,21-dihydroxy-16 beta- O OH
O
Impurity H methyl-3,20-dioxopregna-1,4-dien-17-yl HO O
propanoate
(beclometasone 17-
Cl
propionate) O