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Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1. Acebutolol Hydrochloride
Acebutolol Related
Compound A
(N-(3-acetyl-4-hydroxyphenyl) butanamide) (AS) ON
H
HO
O
2. Acetazolamide EP Impurity B 2- (ACETYL.AMINO)-1,3,4-
THIADIAZOLE S
N N
NH
O
3. Acetazolamide EP Impurity C 2- (acetyl.amino)-1,3,4-
thiadiazole-5-thiol S
N N
SHNH
O
4. Acetazolamide EP Impurity D S
NN
S
O
OH2N NH2
5. Acetazolamide Acetazolamide 2-(acetyl amino)-1,3,4-
thiadiazole-5 sulfonamide S
NN
S
O
OH2N N
H
O
6. Acetazolamide EP Impurity 4-Amino -2-(trifluoromethyl)
benzonitrile
N
F
F
F
H2N
7. Acetazolamide EP Impurity 4-Amino -3-
(trifluoromethyl)benzonitrile N
F
FF
H2N
8. Acitretin Acitretin Related
Compound A
((2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-
dimethylnona-2,4,6,8-tetraenoic acid)
O
OH
O
9. Acitretin Acitretin Related
Compound B
(ethyl (all-E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-
dimethylnona-2,4,6,8-tetraenoate)
O
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
10. Acyclovir Acyclovir Related
Compound A
(2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-
yl)methoxy]ethyl acetate) O
O
O
N
NN
HN
O
H2N
11. Adefovir Dipivoxil Adefovir Dipivoxil
9-[[[2-hydroxyphosphonyl] methoxy] ethyl]adenine
NN
H2NN
N
O
HO
PO
OH
12. Adefovir Dipivoxil EP Impurity A (pivaloyloxy)methyl hydrogen
(2-(6-amino-9H-purin-9-yl)ethoxy)methylphosphonate
13. Albuterol Sulfate Albuterol Related
Compound A
(4-[2-[(1,1-dimethylethyl)amino]-1-
hydroxyethyl]-2-methylphenol sulfate) OH
NH
HO
S
O
O
HO
OH
14. Alfuzosin Hydrochloride
EP Impurity A
N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-
yl](methyl)amino]propyl]furan-2-carboxamide hydrochloride
15. Alfuzosin Hydrochloride
EP Impurity B 2-chloro-6,7-
dimethoxyquinazolin-4-amine
N
N
NH2
O
O
Cl
16. Alfuzosin Hydrochloride
EP Impurity D
N-(4-Amino-6,7-dimethoxyquinozolin-2yl)-N-methylpropane-1,3-diamine
hydrochloride
N
H2N
N
N
O
O
NH2
17. Alfuzosin Hydrochloride
EP Impurity E
N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-
yl](methyl)amino]propyl] formamide O
HN
N
N
N
O
O
NH2
18. Allantoin EP Impurity A glyoxylic acid O
O
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
19. Allantoin EP Impurity B Urea NH2
O
H2N
20. Allopurinol EP Impurity F hydrazine H2N NH2
21. Allopurinol Allopurinol
Related Compound A
3-Amino-4-carboxamidopyrazole
Hemisulfate
22. Allopurinol Allopurinol
Related Compound B
5-(formylamino)-1H-pyrazole-4-carboxamide NH
NO
H2N
HN
O
23. Allopurinol Allopurinol
Related Compound C
5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide
NH
NO
H2N
NN
N
24. Allopurinol Allopurinol
Related Compound D
ethyl 5-amino-1H-pyrazole-4-carboxylate NH
N
O
O
NH2
25. Allopurinol Allopurinol
Related Compound E
ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate
HNN
O
ONHO
26. Allopurinol Allopurinol
Related Compound F
(ethyl-(E/Z)-3-(2-carbethoxy-2-cyanoethenyl)amino-1H-pyrazole-4-carboxylate)
HN N
OO
NH
N
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
27. Almotriptan Malate Almotriptan
Related Compound A
({3-[2-(Dimethylamino)ethyl]-5-[(pyrrolidine-1-
yl)sulfonylmethyl]-1H-indol-1-yl}methanol) HO
N
S
O
O
N
N
28. Alprazolam Alprazolam
Related Compound A
(2-(2-acetylhydrazino)-7-chloro-5-phenyl-3H-1,4-
benzodiazepine)
N
N
Cl
NH
HN
O
29. Alvimopan ALVIMOPAN
R,R,R-ISOMER
[[2(R) -[[4-(R)-(3-Hydroxyphenyl)-3(R),4-
dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]acetic
acid(R,R,R-Isomer) O
OHNH
(R)
O
N
(R)(R)
HO
30. ALVIMOPAN ALVIMOPAN
Impurity 1-hydroxy benzo triazole N
NN
OH
31. ALVIMOPAN ALVIMOPAN
Impurity
(2S,3R,4R)-4-(3-Hydroxyphenyl)-3,4-dimethyl-
alpha-(phenylmethyl)-1-piperidine propanoic
acid(Alvimopan Metabolite)
NO
OH
HO
32. ALVIMOPAN ALVIMOPAN
Impurity
Isobutyl-2-((s)-2-bnezyl-3-((3R, 4R)-4-(3-hydroxyphenyl)-3,4-
dimethylpiperidin-1-yl)propanamido)acetate(Isobu
tyl ester impurity) O
OO N
H
N
HO
33. Amiloride Hydrochloride
Amiloride Related
Compound A
(Methyl 3,5-diamino-6-chloropyrazine-2-carboxylate)
(AS) N
NO
O
Cl
NH2
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
34. Amiodarone Hydrochloride
Amiodarone Related
Compound D
((2-butylbenzofuran-3-yl)(4-hydroxy-3,5-
diiodophenyl)methanone) O I
I
OHO
35. Amiodarone Hydrochloride
Amiodarone Related
Compound E
((2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone)
O
OHO
36. Amiodarone Hydrochloride
Amiodarone Related
Compound H
(2-chloro-N,N-diethylethanamine
hydrochloride) N
Cl
H Cl
37. Amitriptyline Hydrochloride
Amitriptyline Related
Compound A dibenzosuberone
O
38. Amitriptyline Hydrochloride
Amitriptyline Related
Compound B
(5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-
dibenzo[a,d]-cyclohepten-5-ol)
OH
N
39. Amlodipine EP Impurity G
3-Methyl 5-methyl 4-(2-chlorophenyl)-2,6-dimethyl-
1,4-dihydropyridine-3,5-dicarboxylate
NH
O
O O
O
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
40. Amlodipine EP Impurity B
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-
[[2-(methylcarbamoyl) benzoyl]amino]ethoxy]methyl
]-1,4-dihydropyridine-3,5-dicarboxylate
NH
O O
O
O
ONH
O
HNO
Cl
41. Amlodipine EP Impurity A
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-
dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-
1,4-dihydropyridine-3,5-dicarboxylate
NH
OO
O
O
O NO
O
Cl
42. Amlodipine EP Impurity D
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-
chlorophenyl)-6-methylpyridine-3,5-
dicarboxylate
N
O O
O
O
Cl
ONH2
43. Amlodipine EP Impurity F
dimethyl 2-((2-aminoethoxy)methyl)-4-(2-
chlorophenyl)-1,4-dihydro-6-methylpyridine-3,5-
dicarboxylate benzene sulfonate
HN
O
O
O
O
Cl
ONH2
44. Amlodipine EP Impurity E
diethyl 2-((2-aminoethoxy)methyl)-4-(2-
chlorophenyl)-1,4-dihydro-6-methylpyridine-3,5-
dicarboxylate benzenesulphonate
HN
O
O
O
O
Cl
O
NH2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
45. Amlodipine EP Impurity I
3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(4-
chlorophenyl)-1,4-dihydro-6-methylpyridine-3,5-
dicarboxylate
HN
O
O
O
O
Cl
O
NH2
46. Amlodipine EP Impurity H
3-Ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-[2-
[(2-carboxybenzoyl) amino ethoxy)]methyl]-1,4-dihydropyridine-3,5-
dicarboxylate
47. Amlodipine Besylate
Amlodipine Related
Compound A
(3-Ethyl, 5-methyl [2-(2-aminoethoxymethyl)-4-(2-
chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate]
fumarate)
N
O
O
O
O
Cl
ONH2
.Fumarate
48. Amoxicillin EP Impurity A 6-aminopenicillanic acid NH
S
O
O
OH
H2N
49. Amoxicillin Amoxicillin
50. Amoxicillin Amoxicillin
Related Compound A
((2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid)
N
S
O
HO
O NH2
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
51. Amoxicillin Amoxicillin
Related Compound C
((4S)-2-[5-(4-hydroxyphenyl)-3,6-dioxopiperazin-2-yl]-5,5-
dimethylthiazolidine-4-carboxylic acid)
S
HN O
HO
NH
HN
O
O
HO
52. Amoxicillin Amoxicillin
Related Compound I
((R)-2-Amino-2-(4-hydroxyphenyl)acetic acid)
O
OH
HO
NH2
53. Ampicillin EP Impurity A 6-aminopenicillanic acid NH
S
O
O
OH
H2N
54. Ampicillin EP Impurity L D-phenylglycine HNO
HO
55. Amrinone Amrinone
Related Compound A
(5-carboxamide[3,4'-bipyridin]-6(1H)-one)
56. Amrinone Amrinone
Related Compound B
57. Amrinone Amrinone
Related Compound C
(1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-carbonitrile)
HN
NN
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
58. AMTOLMETIN GUACIL
EP Impurity 1-Methyl-5-(4-
methylbenzoyl)-1H-pyrrole-2-acetic acid
N
O
HO
O
59. AMTOLMETIN GUACIL
EP Impurity N-[[1-Methyl-5-(4-
methylbenzoyl)-1H-pyrrol-2-yl]acetyl]glycine
HN
O
OHO
NO
60. Anastrozole Anastrozole 2,2'-[5-(4H-1,2,4-Triazol-4-
ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile) N
NNN
N
61. Anastrozole Anastrozole
Related Compound A
(2,2'-(5-methyl-1,3-phenylene)bis(2-
methylpropanenitrile)) N
N
62. Aripiprazole Aripiprazole
Related Compound B
7-(4-hydroxy-butoxy)-3,4-dihydroquinolin-2(1H)-one N
HO O
OH
63. Aripiprazole EP Impurity D Bis-(3,4 dihydrocarbostyril-7-
oxy) 1,4 butane NH
O OO
HN O
64. Aripiprazole EP Impurity E 7-(4-Chlorobutoxy)-3,4-dihydroquinolin-2-one N
HO O
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
65. Aripiprazole
USP
Aripiprazole
quinoline
impurity
7-Hydroxy-3,4-dihydroquinolin-2(1H)-one N
HO OH
66. Aripiprazole Aripiprazole
Related Compound C
(1- (2,3-Dichlorophenyl)
piperazine HCl) NHN
ClCl
67. Aripiprazole Aripiprazole
Dehydro impurity
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-2(1H)-
quinolinone
HN
O
O
N
N
Cl
Cl
68. Aripiprazole Aripiprazole
Related Compound F
(4-(2,3-dichlorophenyl)-1-[4-(2-oxo-1,2,3,4-
tetrahydroquinolin-7-yloxy)butyl]piperazin 1-oxide)
HN
O
O
N
N
Cl
Cl
O
69. Aripiprazole Aripiprazole
Related Compound G
(7-{4-[4-(2,3-
dichlorophenyl)piperazin-1-
yl]butoxy}quinolin-2(1H)-one)
HN
O
O
N
N
Cl
Cl
70. Aripiprazole EP Impurity A 7-(4-Bromobutoxy)-1,2,3,4-tetrahydroquinoline-2-one N
HO O
Br
71. Aripiprazole EP Impurity B
7-(4-(4-(3-
chlorophenyl)piperazin-1-
yl)butoxy)-3,4-
dihydroquinolin-2(1H)-one
HN
O
O
N
N
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
72. APREPITANT
APREPITANT Related
Compound B (S,R,S
Enantiomer)
5-[2(S)-[1(R)-[3,5-
Bis(trifluoromethyl)phenyl]
ethoxy]]-3(S)-(4-
flurophenyl)morpholin-4-yl-
methyl]-3, 4-dihydro-2H-1, 2,
4-triazole-3-one NH
NNH
O
O N
F
OF
F
F
F
FF
73. APREPITANT APREPITANT USP impurity
Methyl 2-[2-((2R,3S)-2- ((1R)-
1-(3,5-bis(trifluoromethyl)
phenyl)ethoxy)-3-(4-
fluorophenyl)-4-morpholinyl)-
1-iminoethyl]hydrazine
carboxylate HN
NH
HN
NO
F
O
F
F
F F
FF
O
O
74. Artemether Artemether
Related Compound A
((3R,5aS,6R,8aS,9R,12R,12aR)-Decahydro-10-hydroxy-3,6,9-
trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin)
O
O
OO
HO
75. Artemether Artemether
Related Compound B
((3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-
12H-pyrano[4,3-j]-1,2-benzodioxepin)
O
O
OO
O
76. Articaine Hydrochloride
Articaine Related
Compound A
(Methyl 4-methyl-3-[2-(propylamino)acetamido]thio
phene-2-carboxylate) S
O
OO
HN
NH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
77. Articaine Hydrochloride
Articaine Related
Compound E
(Methyl 3-[2-(isopropylamino)propanamido
]-4-methylthiophene-2-carboxylate)
S
OO
O
NH
HN
78. Aspartame EP Impurity B L-aspartyl-L-phenylalanine NH
O
HO
NH2
O
OH
O
79. Aspartame EP Impurity C phenylalanine
H2N
O
OH
80. Aspartame EP Impurity C phenylalanine
H2N
O
OH
81. Aspartame EP Impurity A 2-(5-benzyl-3,6-
dioxopiperazin-2-yl)acetic acid (diketopiperazine),
O
HO NH
HN
O
O
82. Aspartame Aspartame
83. Aspartame Aspartame
Related Compound A
(5-Benzyl-3,6-dioxo-2-piperazineacetic Acid)
NH
HN
O
HO O
O
84. Aspirin EP Impurity A 4-hydroxybenzoic acid O
HO
OH
85. Aspirin EP Impurity B 4-hydroxyisophthalic acid
O
OH
O
HO
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
86. Aspirin EP Impurity C salicylic acid
HO
O
HO
87. Aspirin EP Impurity D acetylsalicylsalicylic acid
88. Aspirin EP Impurity E salicylsalicylic acid
89. Aspirin EP Impurity F acetylsalicylic anhydride O
O
O O
O
O
O
90. Atenolol EP Impurity A 2-(4-
hydroxyphenyl)acetamide
O
H2N
OH
91. Atenolol EP Impurity B 2-(4-((oxiran-2-
yl)methoxy)phenyl)acetamide O
NH2
OO
92. Atenolol EP Impurity D 2-(4-(3-chloro-2-
hydroxypropoxy)phenyl)acetamide
O
H2N
OOH
Cl
93. Atorvastatin EP Impurity B
(3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-
fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-
dihydroxyheptanoic acid calcium salt
N
O
HN
Ph
(R) (S) O
OH OH O
Ca+2
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
94. Atorvastatin EP Impurity D 3-(4-Fluorobenzoyl)-2-
isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide
O
O
HN
OO
F
95. Atorvastatin Atorvastatin-2-
hydroxy impurity
(3R,5R)-7-(3-(2-hydroxyphenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)-3,5-
dihydroxyheptanoic acid
O
OHOH OH
N
F
NH
O
OH
96. Atorvastatin Atorvastatin-4-
hydroxy impurity
(3R,5R)-7-(3-(4-hydroxyphenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)-3,5-
dihydroxyheptanoic acid
O
OHOH OH
N
F
NH
O
HO
97. Atorvastatin EP Impurity F
(3R,5R)-7-{(3R,5R)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-
1H-pyrrol-1-yl]-3,5-dihydroxyheptanamido}-3,5-
dihydroxyheptanoic acid calcium salt
Ca++
O
O-
OH OH
O
HN
OH OH
N
HNO
F
98. Atorvastatin Ep Impurity G(Ats-3-O-
methyl)
(3R,5R)-7-(3-(phenylcarbamoyl)-5-(4-
fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)-5-
hydroxy-3-methoxyheptanoic acid calcium salt
N
O
HN
Ph
(R) (R) O
OH O O
Ca+2
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
99. Atorvastatin Atorvastatin Acetonide impurity
2-((4R,6R)-6-(2-(3-(phenylcarbamoyl)-5-(4-
fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-
yl)acetic acid
N
O
HN
Ph
OH
O O O
F
100. Atorvastatin Atorvastatin
Lactone impurity
5-(4-Fluorophenyl)-1-{2-[(2R, 4R)-4-hydroxy-6-
oxotetrahydro-2H-pyran-2-yl]ethyl}-2-isopropyl-N,4-
diphenyl-1H-pyrrole-3-carboxamide
N
O
HN
Ph
(R)
F
O
(R)
OH
O
101. Atorvastatin ATS-L-1 impurity
tert-butyl 2-((4R,6R)-6-(2-(3-(phenylcarbamoyl)-2-
isopropyl-4,5-diphenyl-1H-pyrrol-1-yl)ethyl)-2,2-
dimethyl-1,3-dioxan-4-yl)acetate
N
O
HN
Ph
O
O O O
F
102. Atorvastatin Methyl ester
impurity
(3R,5R)-methyl 7-(3-(phenylcarbamoyl)-5-(4-
fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)-3,5-
dihydroxyheptanoate
N
O
HN
Ph
O
OH OH O
F
103. Atorvastatin Atorvastatin
Related Compound A
(Desfluoro impurity, or (3R,5R)-7-[3-
(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-
pyrrol-1-yl]-3,5-dihydroxyheptanoic acid
calcium salt)
N
O
HN
Ph
(R) (R) O
OH OH O
Ca+2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
104. Atorvastatin Atorvastatin
Related Compound B
(3S,5R isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-
fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-
dihydroxyheptanoic acid calcium salt)
N
O
HN
Ph
(R) (S) O
OH OH O
Ca+2
F
105. Atorvastatin Atorvastatin
Related Compound C
(Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-
bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-
dihydroxyheptanoic acid calcium salt)
O
OHOH OH
N
FF
NH
O
106. Atorvastatin Atorvastatin
Related Compound D
(Epoxide impurity, or 3-(4-Fluorobenzoyl)-2-isobutyryl-3-
phenyl-oxirane-2-carboxylic acid phenylamide)
O
O
HN
OO
F
107. Atorvastatin Atorvastatin
Related Compound E
(3S, 5S enantiomer of Atorvastatin Calcium) N
O
HN
Ph
(S) (S) O
OH OH O
Ca+2
F
108. ATOMOXETINE HYDROCHLORIDE
Impurity Phenyl-N-methyl-N-[3-(O-
tolyloxy)-3-phenylpropyl]carbamate
NO
O
O
109. ATOMOXETINE HYDROCHLORIDE
Impurity (S-ISOMER)
S(+)-N-Methyl-3-(2-methylphenoxy)-3-
phenylpropylaminehydrochloride
NH O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
110. Atovaquone Atovaquone
Related Compound A
(cis-2-[4-(4-chlorophenyl)cyclohexyl]-3-
hydroxy-1,4-naphthoquinone)
O
O
HO
Cl
111. Atovaquone Atovaquone
Related Compound
4-(4-Chlorophenyl)-cyclohexane carboxylic acid
Cl
O
OH
112. Atovaquone Atovaquone
Related Compound
2-Chloro-3-[4-(4-chlorophenyl)cyclohexyl]-
[1,4]naphthaquinone
O
O
Cl
Cl
113. Atropine EP Impurity C (2RS)-3-hydroxy-2-
phenylpropanoic acid (tropic acid)
O
OH
OH
114. AZACITIDINE AZACITIDINE
Related Compound A
4-Amino-1,3,5-triazin-2(1H)-one
NH
N
N
OH2N
115. AZACITIDINE AZACITIDINE
Impurity
1-(2,3,5-Tri-o-acetyl-beta-D-ribofuranosyl)-4-amino-1,3,5-
triazin-2(1H)-one(Acetyl protected Azacitidine)
N
N
N
ONH2
OO
OOO
O
O
116. Azelastine EP Impurity A benzoyldiazane NHH2N
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
117. Azelastine EP Impurity C 2-[(4-
chlorophenyl)acetyl]benzoic acid
O
HO
O
Cl
118. Azelastine EP Impurity D 4-(4-chlorobenzyl)phthalazin-
1(2H)-one NH
NOCl
119. Azelastine EP Impurity A benzoyldiazane
(benzohydrazide), NHH2N
O
120. Azelastine EP Impurity D 4-(4-chlorobenzyl)phthalazin-
1(2H)-one NH
NOCl
121. Azelastine EP Impurity E 3-(4-chlorobenzylidene)
isobenzofuran-1(3H)-one
O O
Cl
122. Azelastine EP Impurity C 2-[(4-chlorophenyl)acetyl]
benzoic acid,
O
HO
O
Cl
123. Azithromycin EP Impurity A 6-demethylazithromycin
124. Azithromycin EP Impurity B 3-deoxyazithromycin
125. Azithromycin EP Impurity E -(N,N-
didemethyl)azithromycin (aminoazithromycin)
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
126. Azithromycin EP Impurity F -N-demethyl-
Nformylazithromycin
127. Azithromycin EP Impurity G -N-demethyl- -N-[(4-
methylphenyl)sulphonyl]azithromycin
128. Azithromycin EP Impurity H N[[4(acetylamino)phenyl]su
lphonyl]- -N-demethylazithromycin
129. Azithromycin EP Impurity I -N-demethylazithromycin
130. Azithromycin EP Impurity J 13-O-
decladinosylazithromycin
131. Azithromycin EP Impurity L - N-oxide
132. Azithromycin EP Impurity M -(N,N-didemethyl)- -N-
formylazithromycin
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
133. Azithromycin EP Impurity N -de(dimethylamino)- -
oxoazithromycin
134. Bambuterol EP Impurity A (1RS)-1-(3,5-dihydroxyphenyl)-
2-[(1,1-dimethylethyl) amino]ethanol (terbutaline) N
H
OH
HO
OH
135. Benzbromarone EP Impurity C (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone
(benzarone) O
OH
O
136. BENDAMUSTINE HYDROCHLORIDE
EP Impurity (Methyl ester)
1H-benzimidazole-1-methyl-5-N,N-di(2-chloro ethyl)-2-butanoicacid ethylester
(Bendamustine ethyl ester) O
O
N
N
NCl
Cl
137. Betahistine EP Impurity A 2-ethenylpyridine (2-
vinylpyridine) N
138. Betahistine EP Impurity B 2-(pyridin-2-yl)ethanol N
HO
139. Bezafibrate EP Impurity B 4-chlorobenzoic acid O
HO
Cl
140. Bezafibrate EP Impurity C methyl 2-[4-[2-[(4-
chlorobenzoyl)amino]ethyl]phenoxy]-2 methylpropanoate O
O
O
NH
O
Cl
141. Bezafibrate EP Impurity D ethyl 2-[4-[2-[(4-
chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoate O
OO
HN
O
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
142. Bezafibrate EP Impurity E butyl 2-[4-[2-[(4-
chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoate
O
OO
NH
O
Cl
143. Bicalutamide EP Impurity A Defluoro Bicalutamide
impurity
O
NH
OH
S
O
OF
FF
N
144. Bicalutamide Bicalutamide
Related Compound A
N-[4-Cyano-2-(trifluoromethyl)phenyl]-3-[(4-
fluorophenyl)sulfinyl]-2-hydroxy-2-methyl-
propanamide
O
HN
OH
S
O
F F
F
F N
145. Bicalutamide Bicalutamide
Related Compound B
N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(3-
fluorophenyl)sulfonyl]-2-hydroxy-2-
methylpropanamide
O
NHOH
S
O
O
F
F
FF
N
146. Bicalutamide EP Impurity A
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-
[(phenyl)sulfonyl]-2-hydroxy-2-methylpropanamide
O
HN
OH
S
O
O
F
FF
N
147. Bicalutamide EP Impurity J
N-[4-Cyano-3-(trifluoromehtyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-
2-methylpropanamide O
HN
OHS
F
F
F
F
N
148. Bicalutamide EP Impurity C
N-[4-Cyano-3-(trifuoromethyl)phenyl]-3-[(4-
fluorophenyl)sulfonyl]-2-methylpropanamide
O
NH S
O
OFF
FF
N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
149. Bicalutamide EP Impurity D 4-Amino -2-(trifluoromethyl) benzonitrile
N
F
F
F
H2N
150. Bicalutamide EP Impurity
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(2-
fluorophenyl)sulfinyl]-2-hydroxy-2-methyl-
propanamide
O
HN
OH
SO
FF
FF
N
151. Bicalutamide EP Impurity
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-
fluorophenyl)sulfinyl]-2-Acetyloxy-2-methyl-
propanamide
O
HN
O
O
SO
F
F
FF
N
152. Bicalutamide EP Impurity
2,3-Epoxy-2-mehyl-N-[4-Cyano-3-
(trifluoromethyl)phenyl]propanamide
O
HN
FF
F
N
O
153. Bicalutamide EP Impurity
N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(4-
fluorophenyl)sulfonyl]-2-hydroxy-2-
methylpropanamide
O
NH
OH
S
O
OFF
FF
N
154. Bicalutamide EP Impurity 4-Amino -3-(trifluoromethyl)benzonitrile
N
F
FF
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
155. Bisoctrizole Bisoctrizole
Related Compound A
(2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)
phenol)
OH
NN
N
156. Bisoprolol Fumarate EP Impurity S 4-hydroxybenzaldehyde O
OH
157. BORTEZOMIB BORTEZOMIB
Impurity
N-((S)-1-carbamoyl-2-phenylethyl)pyrazine-2-
carboxamide
N
NO
HN
NH2O
158. BORTEZOMIB BORTEZOMIB
Impurity N-(Pyrazine-2-ylcarbonyl)-L-
Phenylalanine
HN
OHOO
N
N
159. BORTEZOMIB BORTEZOMIB
Impurity
[(1(R)-3-methyl-1-[[(2R)-1-oxo-3-phenyl-2-
[(pyrazinylcarbonyl)amino]propyl]
amino]butyl] boronicacid N
NNH
OHN
O
BOH
OH
160. BORTEZOMIB BORTEZOMIB
Impurity
N(S)-(1-(1(R)-hydroxy-3-methyl butyl amino)-1-oxo-3-
phenyl propane-2- yl)pyrazine-2-carboxamide
N
N O
HN
O
NH
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
161. BORTEZOMIB BORTEZOMIB
Impurity
N(S)-(1-(1(S)-hydroxy-3-methyl butyl amino)-1-oxo-3-
phenyl propane-2- yl)pyrazine-2-carboxamide
N
N O
HN
O
NH
HO
162. BOSENTAN MONOHYDRATE
BOSENTAN
Related
Compound A
4-(1,1-Dimethylethyl)-N-[6-chloro-5-(2-methoxy-
phenoxy)-[2,2']bipyrimidinyl-4-yl]benzene sulfonamide
S
O
ONH
N
N
N
N
O
O Cl
163. BOSENTAN MONOHYDRATE
BOSENTAN
Related
Compound B
4-(1,1-Dimethylethyl)-N-[6-hydroxy-5-(2-methoxy-
phenoxy)-[2,2']bipyrimidinyl-4-yl]benzene sulfonamide
S
O
ONH
N
N
N
N
O
O OH
164. BOSENTAN MONOHYDRATE
BOSENTAN
Related
Compound C
(1,2-bis({6-[4-(tert-butyl)phenylsulfonamido]-5-(2-methoxyphenoxy)-[2,2'-
bipyrimidin]-4-yl}oxy)ethane)
O
NN
N N
O
O
SO O
HNO
N N
NN
O
O
S
O
O
HN
165. BOSENTAN MONOHYDRATE
BOSENTAN
Related
Compound E
4-(1,1-Dimethylethyl) benzenesulfonamide
S
O
O
NH2
166. Bretylium Tosilate EP Impurity A 2-bromobenzyldimethylamine N
Br
167. Bretylium Tosilate EP Impurity B 3-bromobenzyldimethylamine N
Br
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
168. Bretylium Tosilate EP Impurity C 4-bromobenzyldimethylamine N
Br
169. Bromhexine Hydrochloride
EP Impurity B 2-amino-3,5-
dibromobenzaldehyde
O
Br
Br
NH2
170. Bromhexine Hydrochloride
EP Impurity C N-(2-aminobenzyl)-N-
methylcyclohexanamine N
NH2
171. Brompheniramine Maleate
EP Impurity A chlorphenamine
N
N
Cl
172. Brompheniramine Maleate
EP Impurity B dexchlorpheniramine
N
N
Cl
173. Buclizine Hydrochloride
EP Impurity A 1,4-bis(4-
chlorobenzhydryl)piperazine N
N
Cl
Cl
174. Buclizine Hydrochloride
EP Impurity B 4-chlorobenzhydrol, 1-(4-
chlorobenzhydryl)piperazine N
NH
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
175. Buclizine Hydrochloride
EP Impurity C 4-chlorobenzophenone
O
Cl
176. Bufexamac EP Impurity A 2-(4-butoxyphenyl)acetic acid O
HO
O
177. Bufexamac EP Impurity B methyl 2-(4-
butoxyphenyl)acetate O
O
O
178. Bufexamac EP Impurity D 2-(4-butoxyphenyl)acetamide O
H2N
O
179. Bupivacaine EP Impurity F 2,6-dimethylaniline H2N
180. Butyl Hydroxybenzoate
EP Impurity A 4-hydroxybenzoic acid O
HO
OH
181. Butyl Hydroxybenzoate
EP Impurity B methyl 4-hydroxybenzoate
O
O
HO
182. Butyl Hydroxybenzoate
EP Impurity C ethyl 4-hydroxybenzoate
O
O
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
183. Butyl Hydroxybenzoate
EP Impurity D propyl 4-hydroxybenzoate
O
O
HO
184. Butylated Hydroxyanisole
EP Impurity A benzene-1,4-diol (hydroquinone).
HO OH
185. Caffeine EP Impurity A theophylline NH
NN
N
O
O
186. Caffeine EP Impurity D theobromine N
NN
HN
O
O
187. Caffeine EP Impurity F 1,7-dimethyl-3,7-dihydro-1H-
purine-2,6-dione
N
NNH
N
O
O
188. Calcium Dobesilate Monohydrate
EP Impurity A benzene-1,4-diol (hydroquinone).
HO OH
189. Calcium Levofolinate Pentahydrate
EP Impurity A (2S)-2-[(4-
aminobenzoyl)amino]pentanedioic acid
O
OH
O
HO
HN
O
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
190. Calcium Levofolinate Pentahydrate
EP Impurity C folic acid O
HO
O
HO
O
HN
HN
N
N
N
N
OH
H2N
191. Candesartan Cilexetil
EP Impurity A
ethyl 2-ethoxy-1-[[2′ -(1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-1H-benzimidazole-7-carboxylate
192. Candesartan Cilexetil
EP Impurity B
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]
ethyl 2-oxo-3-[[2′ -(1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-2,3-dihydro-1H-benzimidazole-4-carboxylate
193. Candesartan Cilexetil
EP Impurity C
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]
ethyl 3-[[2′ -(1-ethyl-1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-2-oxo-2,3-dihydro-1H-benzimidazole-4-
carboxylate
194. Candesartan Cilexetil
EP Impurity D
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]
ethyl 3-[[2′ -(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-2-oxo-2,3-dihydro-1H-benzimidazole-4-
carboxylate
195. Candesartan Cilexetil
EP Impurity E
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2′ -(1-ethyl-
1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-
7-carboxylate
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
196. Candesartan Cilexetil
EP Impurity F
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2′ -(2-ethyl-
2H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-
7-carboxylate
197. Candesartan Cilexetil
EP Impurity G
2-ethoxy-1-[[2′ -(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-
benzimidazole-7-carboxylic acid (candesartan)
198. Candesartan Cilexetil
EP Impurity H
(1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]
ethyl 2-ethoxy-1-[[2′ -[1-(triphenylmethyl)-1H-tetrazol-5-yl]biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate
(N-tritylcandesartan)
199. CAPECITABINE Capecitabine
Related Compound B
(5'-deoxy-5-fluorouridine)
200. CAPECITABINE Capecitabine
Related Compound A
5'-Deoxy-5-fluorocytidine
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
201. CAPECITABINE Capecitabine Impurity
2,3-di-o-acetyl-5'-deoxy-5-fluorocytidine
O
O O
OO
N NH2
F
O
202. CAPECITABINE Capecitabine
Impurity
5'-Deoxy-5-fluoro-N4-(2-methyl-1-
butyloxycarbonyl)cytidine
O
HOOH
NHN
F
O O
O
203. CAPECITABINE Capecitabine
Impurity
5'-Deoxy-5-fluoro-N4-(3-methyl-1-
butyloxycarbonyl)cytidine
O
HOOH
NHN
F
O O
O
204. Carbamazepine EP Impurity E 10,11-dihydro-5H-
dibenzo[b,f]azepine (iminodibenzyl), N
H
205. Carbamazepine Carbamazepine
Related Compound A
(10,11-dihydrocarbamazepine)
206. Carbamazepine Carbamazepine
Related Compound B
(Iminostilbene) NH
207. Carbaryl EP Impurity A 1-naphthol
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
208. Carbasalate Calcium EP Impurity B
2-[[2-(acetyloxy)benzoyl]oxy]benzoi
c acid (acetylsalicylsalicylic acid),
OHO
O
O O
O
209. Carbasalate Calcium EP Impurity C 2-hydroxybenzoic acid
(salicylic acid). O
HO
HO
210. Carbimazole EP Impurity A 1-methyl-1H-imidazole-2-thiol
(thiamazole). N
NSH
211. Carboplatin EP Impurity A cisplatin
212. Carboplatin EP Impurity B cyclobutane-1,1-dicarboxylic
acid
OHOO
OH
213. Carprofen Carprofen
214. Carprofen Carprofen
Related Compound A
9H-carbazole
HN
215. Carvedilol Carvedilol
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
216. Carvedilol Carvedilol
Related Compound D
(4-(Oxiran-2-ylmethoxy)-9H-carbazole)
NH
O
O
217. Carvedilol Carvedilol
Related Compound E
(2-(2-methoxyphenoxy)ethylamine) NH2
OO
218. Carvedilol Chloroquine
Related Compound A
(4,7-dichloroquinoline)
NCl
Cl
219. Cefaclor EP Impurity A (2R)-2-amino-2-phenylacetic
acid (phenylglycine), O
HO
NH2
220. Cefaclor EP Impurity F 3-phenylpyrazin-2-ol N
N
OH
221. Cefadroxil Monohydrate
EP Impurity A (2R)-2-amino-2-(4-
hydroxyphenyl)acetic acid,
O
OH
HO
NH2
222. Cefadroxil Monohydrate
EP Impurity G 3-hydroxy-4-methylthiophen-
2(5H)-one, S
O
HO
223. Cefalotin Sodium EP Impurity C
(6R,7R)-3-[(acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (7-ACA),
N
S
O OH
O
H2N
O
O
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
224. Cefazolin Sodium EP Impurity E 5-methyl-1,3,4-thiadiazol-2-
thiol (MMTD), S
N N
HS
225. Cefazolin Sodium EP Impurity H
(6R,7R)-3-[(acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (7-ACA),
N
S
O OH
O
H2N
O
O
H
226. CEFPROZIL CEFPROZIL Impurity
(6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3-
methyl-8-oxo-5-thia-1azabicyclo[4,2,0]oct-2-ene-2-
carboxylic acid
N
S
O
HO
O O
NH
OH
NH2
H
227. CEFPROZIL CEFPROZIL
Impurity
[R(Z)]-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-
1-enyl)amino]acetate; OHO
HN
OOHO
228. CEFPROZIL CEFPROZIL
Impurity 7-Amino-3-(Z-propen-1-yl)-3-
cephem-4-carboxylic acid
SH2N
O
OHO
CH3
HH
229. CEFPROZIL CEFPROZIL
Impurity 7-Amino-3-(E-propen-1-yl)-3-
cephem-4-carboxylic acid.
SH2N
O
OHO
230. CELECOXIB
CELECOXIB
Related
Compound A
4-[5-(3'Methylphenyl)-3-(tri fluoromethyl)-1H-Pyrazol-1-yl]
benzene sulfonamide EP-C S
O
O
NH2N
NF
FF
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
231. CELECOXIB
CELECOXIB
Related
Compound B
(4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-
1-yl]benzenesulfonamide) EP-A
S
O
O
NH2NN
FF
F
232. CELECOXIB EP Impurity D (4-[3-(2-methylphenyl)-5-
(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide)
S
O
O
NH2NN
FF
F
233. CELECOXIB CELECOXIB
ISOMER
4-[4-(4'-Methylpenyl)-3-(trifluoromethyl)-1H-
PYRAZOL-1-yl]-benzensulfonamide
S
O
O
H2N NN
F
F F
234. CELECOXIB
CELECOXIB
REGEIO
ISOMER CELECOXIB REGEIO ISOMER N
N
SNH2
O
O
H3C
CF3
235. CELECOXIB CELECOXIB
METABOLITE
4-[2-hydroxy-5-(4'Methylphenyl)-3-(tri
fluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide
S
O
ONH2
NN
F
F
FHO
236. CELECOXIB CELECOXIB
Impurity [5-(4-Methylphenyl)-3-tri
fluoromethyl-1H-pyrazole] NH
N
F
F
F
237. Cetirizine EP Impurity A (RS)-1-[(4-
chlorophenyl)phenylmethyl]piperazine
NHN
Cl
238. Cetirizine EP Impurity B (RS)-2-[4-[(4-
chlorophenyl)phenylmethyl]piperazin-1-yl]acetic acid O
OHN
N
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
239. Cetirizine EP Impurity C (RS)-2-[2-[4-[(2-
chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid
O
OHO
N
N
Cl
240. Chlorcyclizine Hydrochloride
EP Impurity A N-methylpiperazine. N NH
241. Chlordiazepoxide Hydrochloride
EP Impurity C
(2-amino-5-chlorophenyl)phenylmethano
ne (aminochlorobenzophenone). OCl
H2N
242. Chloroquine Phosphate
Chloroquine Related
Compound A 4,7-dichloroquinoline
NCl
Cl
243. Chlorphenamine Maleate
EP Impurity A
2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-
(dimethylamino)ethyl]butanenitrile
N
N
N
Cl
244. Chlorphenamine Maleate
EP Impurity B N-(pyridin-2-yl)pyridin-2-
amine (2,2¢-dipyridylamine)
N
NH
N
245. Chlorphenamine Maleate
EP Impurity C 3-(4-chlorophenyl)-N-methyl-
3-(pyridin-2-yl)propan-1-amine HN
N
Cl
246. Chlorphenamine Maleate
EP Impurity D 2-(4-chlorophenyl)-4-
(dimethylamino)-2-(pyridin-2-yl)butanenitrile
N
NN
Cl
247. Chlorzoxazone Chlorzoxazone
Related Compound A
2-Amino-4-chlorophenol Cl NH2
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
248. Cholesterol EP Impurity A 5a-cholest-7-en-3b-ol
(lathosterol), OH
H
H
H
249. Cholesterol EP Impurity B cholesta-5,24-dien-3b-ol
(desmosterol), OH
H
H
H
250. Cilostazol Cilostazol Related
Compound A
6-hydroxy-3,4-dihydro-1H-quinolin-2-one
HN O
HO
251. Cilostazol Cilostazol Related
Compound B
6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)-butoxy]-1H-
quinolin-2-one HN
O
ON
NN
N
252. Cinnarizine EP Impurity A 1-(diphenylmethyl)piperazine N
NH
253. Cinnarizine EP Impurity E 1,4-bis(diphenylmethyl)
piperazine. NN
254. Cinnarizine EP Impurity A 1-(diphenylmethyl)piperazine N
NH
255. Cinnarizine EP Impurity C (4-(diphenylmethyl)-1,1-bis[(E)-3-phenylprop-2-
enyl]piperazinium chloride
256. Cinnarizine EP Impurity E 1,4-
bis(diphenylmethyl)piperazine NN
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
257. CINACALCET HYDROCHLORIDE
CINACALCET HYDROCHLORI
DE
(R)-alpha-Methyl-N-[3-[3-(trifluoromethyl)phenyl]methy
l]-1- napthalenemethane amine
hydrochloride
HN
F
FF
(R)
258. CINACALCET
HYDROCHLO
CINACALCET
Impurity (R)-(+)-1-(1-
Naphthyl)ethylamine
H2N
259. CINACALCET
HYDROCHLORIDE
CINACALCET
Impurity
(S-ISOMER)
(S)-alpha-Methyl-N-[-[3-[3-(trifluoromethyl)phenyl]propyl]-1-napthalenemethanamine
hydrochloride
HN
F
FF
(S)
260. CINACALCET
HYDROCHLORIDE
CINACALCET
Impurity
3-(3-(Trifluoromethyl)phenyl)popa
nal
O F
F
F
261. Ciprofloxacin EP Impurity A
7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid
N
O
OH
O
F
Cl
262. Ciprofloxacin EP Impurity C
7-[(2-aminoethyl)amino]-1-cyclopropyl-6-fluoro-4-oxo-
1,4-dihydroquinoline-3-carboxylic acid
(ethylenediamine compound)
N
O
OH
O
F
HN
H2N
263. Ciprofloxacin Hydrochloride
EP Impurity A
7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid(fluoroquinolonic acid),
N
O
OH
O
F
Cl
264. Citalopram EP Impurity B
1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-
dihydro-3-hydroxyisobenzofuran-5-
carbonitrile
O
N
OHF
N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
265. Citalopram Citalopram
Related compound A
1-(3-(dimethylamino)propyl)-1-(4'-fluorophenyl)-1,3-
dihydroisobenzofuran-5-carboxamide
O
O
NH2
F
N
266. Citalopram Citalopram
Related compound D
1-(4'-fluorophenyl)-1-(3-(methylamino)propyl)-1,3-dihydroisobenzofuran-5-
carbonitrile
O
N
HN
F
267. Citalopram Citalopram
Related compound E
1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-
dihydroisobenzofuran-5-carbonitrile-N-oxide
hydrochloride
O
N
F
N
O
268. Citalopram
5-Dimethylamino
butyryl citalopram
1-(3-Dimethylaminopropyl)-1-(4'-fluorophenyl)-5-(4-
dimethylaminobutyryl)-1,3dihydro-isobenzofuran
O
O
N
F
N
269. Citalopram EP Impurity C
1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-
dihydro-3-oxoisobenzofuran-5-carbonitrile
O
N
O
F
N
270. Cladribine EP Impurity C 2-chloro-7H-purin-6-amine (2-
chloroadenine),
HN
NN
N
NH2
Cl
271. Cladribine EP Impurity E 2-deoxy-D-erythro-
pentofuranose (2-deoxy-D-ribose),
OH
HO
OHO
272. Cladribine EP Impurity G methyl 4-methylbenzoate
O
O
273. Clebopride Malate EP Impurity A 4-amino-5-chloro-2-methoxybenzoic acid O
OH
O
Cl
NH2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
274. Clebopride Malate EP Impurity B 1-benzylpiperidin-4-amine, N
H2N
275. Clenbuterol Hydrochloride
EP Impurity A 4-amino-3,5-
dichlorobenzaldehyde,
O
Cl
Cl
H2N
276. Clenbuterol Hydrochloride
EP Impurity D 1-(4-aminophenyl)ethanone NH2
O
277. Clioquinol EP Impurity A 5-chloroquinolin-8-ol,
N
OH
Cl
278. Clioquinol EP Impurity B 5,7-dichloroquinolin-8-ol,
N
OH
Cl
Cl
279. Clioquinol EP Impurity C 5,7-diiodoquinolin-8-ol.
N
OH
I
I
280. Clonidine Hydrochloride
EP Impurity A 1-acetylimidazolidin-2-one, NHN
O
O
281. Clonidine Hydrochloride
EP Impurity C 2,6-dichloroaniline H2N
Cl
Cl
282. Clopamide EP Impurity B 4-chlorobenzoic acid O
HO
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
283. Clopamide EP Impurity C 4-chloro-3-sulfamoylbenzoic
acid,
O
HOS
O
ONH2
Cl
284. Clopidogrel Clopidogrel
Related compound A
(S)-α-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-
5(4H)-acetic Acid N
SO
HO
Cl
H
Cl
285. Clopidogrel Clopidogrel
Related compound B
Methyl (+/-)-(o-Chlorophenyl)-4,5-dihydrothieno[3,2-
c]pyridine-6(7H)acetateHydrochloride
N S
O
HO
Cl
H
Cl
286. Clopidogrel Clopidogrel
Related compound C
(R)-(-)-Methyl 2-(2-Chlorophenyl)-2-(6,7-dihydro-
4H-thieno[3,2-c]pyridin-5-yl)acetate HydrogenSulfate
N
S
O
O
O
SO
O
OH
Cl
287. Clotrimazole EP Impurity A (2-
chlorophenyl)diphenylmethanol,
OH
Cl
288. Clotrimazole EP Impurity D imidazole N
HN
289. Clotrimazole EP Impurity E (2-chlorophenyl)
phenylmethanone (2-chlorobenzophenone),
OCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
290. Clotrimazole EP Impurity C 1-chloro-2-
(chlorodiphenylmethyl) benzene
Cl
Cl
291. Cyclizine Hydrochloride
EP Impurity A 1-methylpiperazine N NH
292. Cyclizine Hydrochloride
EP Impurity B diphenylmethanol
(benzhydrol). OH
293. Cyclophosphamide Cyclophospham
ide Related Compound A
bis(2-chloroethyl)amine hydrochloride
HN
Cl ClH
Cl
294. CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE Related
Compound A
5-(3-Dimehylaminopropyl)-5-hydroxydibenzo[a,e]cyclo
heptatriene OH
N
295. CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE Impurity
5H-Dibenzo[a,d]cyclohepten-5-ol
OH
296. Dacarbazine EP Impurity B 5-amino-1H-imidazole-4-
carboxamide, N
NHO
H2N
H2N
297. Dacarbazine Dacarbazine
Related Compound A
5-aminoimidazole-4-carboxamide hydrochloride
N
NHO
H2N
H2N
H
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
298. Dacarbazine Dantrolene
Related Compound C
5-(4-nitrophenyl)-2-furancarboxyaldehyde
OON+
O
O-
299. DARIFENACIN Darifenacin
Amide Impurity (S)-alpha,alpha-Diphenyl-3-
pyrrolidin acetamide tartarate
HN
O
NH2
HO
OH
O
OH
O
HO
300. DARIFENACIN (R)-Darifenacin Hydrobromide
(3R)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl)-
alpha,alpha-diphenyl-3-pyrrolidin acetamide
hydrobromide
O NH2
N(R)
O
301. DARUNAVIR DARUNAVIR
Impurity
4-Amino-N-(2R,3S)(3-amino-2-hydroxy-4-phenyl-butyl)-N-
isobutyl-benzenesulfonamide
S
O
ON
OH
H2N
NH2
302. DARUNAVIR DARUNAVIR
Impurity
[(1S,2S)-3[[(4-Amino-phenyl)sulfonyl](2-
methylpropyl)amino]-2-hydroxy-1-
(phenylmethyl)propyl]carbamic acid(3R,3aS,6aR)-
hexahydrofuro[2,3-b]-furan-3ylester
NH
OO
OHNS
O
OH2N
OO
H
H
303. Dequalinium Chloride
EP Impurity A 2-methylquinolin-4-amine
N
NH2
304. Desloratadine Desloratadine
Related Compound A
8-chloro-6,11-dihydro-11-(4-piperdinylidene)- 5H-
benzo[5,6]cyclohepta[1,2-b]pyridine
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
305. Desloratadine Desloratadine
Related Compound B
8-Chloro-6,11-dihydro-11-(N-methyl-4-piperidinylidene)-
5H-benzo[5,6]cyclohepta[1,2-b]pyridine
N
N
Cl
306. Desloratadine N-hydroxy impurity
N-hydroxy impurity N
N
OH
Cl
307. Desloratadine Deschloro
desloratadine Deschloro desloratadine
N
NH
308. Desloratadine N-oxide impurity
N-oxide impurity N
NH
Cl
O
309. Dexlansoprazole (S)
Lansoprazole
(S)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)-pyridin- 2-yl]methylsulfinyl)-1H-
benzo[d]imidazole
NH
N S
O N
O
F
FF
310. Dexlansoprazole Dexlansoprazol
e Impurity
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-
pyridinyl]methyl]sulfinyl-1H-benzimidazole1'-oxide(
Dexlansoprazole N-Oxide)
NH
N S(R)
O N
O
F
FF
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
311. Dexlansoprazole Dexlansoprazol
e Impurity
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-
pyridinyl]methyl]thio]-1H-benzimidazole( Sulfide
impurity)
N
NH
S
N
OF
FF
312. Dexlansoprazole Dexlansoprazol
e Impurity
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-
pyridyl]methyl]sulfonyl-1H-benzimidazole( Sulfone
impurity)
NH
N S
O N
O
F
FFO
313. Dexpramipexole Dexpramipexol
e Impurity A (6R)-4,5,6,7-tertrahydro-1,3-
benzothiazol-2,6-diamine S
N
H2NNH2
314. Dexpramipexole Dexpramipexol
e Impurity B
N-[(6R)-2-Amino-4,5,6,7-terthydro-1,3-benxothiazol-6-
yl]propanamide S
N
(R) NH2
NH
O
315. Dexpramipexole Dexpramipexol
e Impurity C
(S)-4,5,6,7-terahydro-N-6-propyl-2,6-
benzothiazolediamine S
N
(S) NH2
NH
316. Dexpramipexole Dexpramipexol
e Impurity
(6R)-6-N-ethyl-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-
2,6-diamine( Ethyl Dexpramipexole)
S
N
(R) NH2
NH
317. Dexpramipexole Dexpramipexol
e Impurity
(R)-4,5,6,7-tetrahydro-N2,N6-dipropylbenzo[d]thiazole-2,6-
diamine S
N
(R) NH
NH
318. Dextroamphetamine
Dextroamphetamine Related Compound A
1-Phenyl-2-propanol OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
319. Dextroamphetamine
Dextroamphetamine Related
Compound B CII Phenyl acetone
O
320. Diazepam EP Impurity A
7-chloro-5-phenyl-1,3-dihydro-2H-1,4-
benzodiazepin-2-one (nordazepam),
NHN
O
Cl
321. Diazepam EP Impurity D [5-chloro-2-
(methylamino)phenyl]phenylmethanone
ONH
Cl
322. Diclofenac EP Impurity A 1-(2,6-dichlorophenyl)-1,3-
dihydro-2H-indol-2-one N
O
Cl
Cl
323. Diclofenac EP Impurity E 1,3-dihydro-2H-indol-2-one NH
O
324. Diclofenac EP Impurity C [2-[(2,6-
dichlorophenyl)amino]phenyl]methanol
OHNH
Cl
Cl
325. Diclofenac EP Impurity B 2-[(2,6-
dichlorophenyl)amino]benzaldehyde
ONH
Cl
Cl
326. Dicloxacillin Sodium EP Impurity C 6-aminopenicillanic acid NH
S
O
O
OH
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
327. Didanosine EP Impurity A hypoxanthine HN
NN
N
OH
328. Didanosine EP Impurity B inosine
OH
OH
HO
O
NN
HO
N N
329. Didanosine EP Impurity C 2'-deoxyinosine HO
HO
O
NN
OH
NN
330. Didanosine EP Impurity F
9-(2,3-dideoxy-b-D-glycero-pent-2-enofuranosyl)-1,9-dihydro-6H-purin-6-one (2¢,3¢-dideoxy-2¢,3¢-
didehydroinosine
331. Didanosine Didanosine
Impurity 5'-O-Acetyl-2',3'-dideoxy
inosine N
N
N NH
O
OAcO
332. Didanosine Didanosine
Related Compound A
Hypoxanthine HN
NN
N
OH
333. Didanosine Didanosine
Related Compound B
2',3'-dideoxyadenosine HO
O
NN
NH2
NN
334. Diethylcarbamazine Citrate
EP Impurity A 1-methylpiperazine N NH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
335. Diethylcarbamazine Citrate
EP Impurity B 1,4-dimethylpiperazine N N
336. Diflunisal EP Impurity A biphenyl-4-ol HO
337. Dihydrocodeine Tartrate
EP Impurity A codeine
O
O
HO H
N
338. Dihydrocodeine Tartrate
EP Impurity B morphine
HO
O
HO H
N
339. Dimenhydrinate EP Impurity E 8-chloro caffeine
340. Dimenhydrinate EP Impurity F N-desmethyl impurity
341. Dimetindene Maleate
EP Impurity A 2-ethylpyridine N
342. Diosmin EP Impurity A 1-(3-hydroxy-4-
methoxyphenyl)ethanone (acetoisovanillone) O
OH
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
343. Diphenhydramine Hydrochloride
EP Impurity D diphenylmethanol
(benzhydrol) OH
344. Diphenhydramine Hydrochloride
EP Impurity E diphenylmethanone
(benzophenone). O
345. Diphenhydramine Hydrochloride
EP Impurity A 2-(diphenylmethoxy)-N-
methylethanamine NH
O
346. Diphenhydramine Hydrochloride
EP Impurity D diphenylmethanol
(benzhydrol), OH
347. Diphenhydramine Hydrochloride
EP Impurity E diphenylmethanone
(benzophenone). O
348. Dipivefrine Hydrochloride
EP Impurity A 4-[(1RS)-1-hydroxy-2-
(methylamino)ethyl]benzene-1,2-diol ((±)-adrenaline)
HO
HO
NH
OH
349. Dipivefrine Hydrochloride
EP Impurity B 1-(3,4-dihydroxyphenyl)-2-
(methylamino)ethanone (adrenalone)
HN
OH
OH
O
350. Dipyridamole EP Impurity B
2: 2,2’,2’’,2’’’,2’’’’,2’’’’[[8-(piperidin-1-yl)pyrimido[5,4-
d]pyrimidine-2,4,6-triyl]trinitrilo]hexaethanol,
N
NN
N
N
N
N
N
OHHOOH
HO
OH
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
351. Dipyridamole EP Impurity A 2,2¢-[[4,6,8-tri(piperidin-1-
yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol,
N
NN
N
N
N
N
N
OH
OH
352. Dipyridamole EP Impurity F
2,2¢,2¢¢,2¢¢¢-[[4-[(2-hydroxyethyl)amino]-8-
(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-
diyl]dinitrilo]tetraethanol
N
NN
N
N
HNOH
N
N
OH
OH
OH
OH
353. Dipyridamole Trichloro
impurity(Mono) 2,4,6-trichloro-8-(piperidin-1-yl)pyrimido[5,4-d]pyrimidine N
NN
N
N
Cl
Cl
Cl
354. Dipyridamole EP Impurity D
2,2¢-[[6-[(2-hydroxyethyl)amino]-4,8-
di(piperidin-1-yl)pyrimido[5,4-d]pyrimidin-2-
yl]nitrilo]diethanol,
N
NN
N
N
N
HN
N
OH
OH
OH
355. Dipyridamole EP Impurity C
2,2¢-[[6-chloro-4,8-di(piperidin-1-yl)pyrimido[5,4-
d]pyrimidin-2-yl]nitrilo]diethanol
N
NN
N
N
N
Cl
N
OH
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
356. Dipyridamole EP Impurity G 2,6-dichloro-4,8-di(piperidin-
1-yl)pyrimido[5,4-d]pyrimidine N
NN
N
N
Cl
Cl
N
357. Dipyridamole EP Impurity E
2,2¢,2¢¢,2¢¢¢-[[6,8-di(piperidin-1-yl)pyrimido[54-
d]pyrimidine-2,4-diyl]dinitrilo]tetraethanol,
N
NN
N
N
N
N
OHHO
OH
OH
358. Dipyridamole Tetrachloro
impurity
2,4,6,8-Tetrachloropyrimidopyrimidin
e
N
NN
N
Cl
Cl
Cl
Cl
359. Dipyridamole Dichloro impurity
Dipyridamole dichloro impurity
N
NN
N
N
Cl
Cl
N
OHHO
360. Dipyrone EP Impurity A 4-formylamino-1,5-dimethyl-
2-phenyl-1,2-dihydro-3H-pyrazol-3-one
N
N
O
NH
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
361. Dipyrone EP Impurity B 4-amino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-
pyrazol-3-one,
N
N
O
H2N
362. Dipyrone EP Impurity C 4-methylamino-1,5-dimethyl-
2-phenyl-1,2-dihydro-3H-pyrazol-3-one
N
N
O
NH
363. Dipyrone EP Impurity D 4-dimethylamino-1,5-
dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one
N
N
O
N
364. Disodium Edetate EP Impurity A nitrilotriacetic acid N
O
OH
O
OH
O
OH
365. Dithranol EP Impurity A anthracen-9(10H)-one
(anthrone)
O
366. Dithranol EP Impurity B 1,8-dihydroxyanthracene-
9,10-dione (dantron),
O
O
OHOH
367. Dobutamine Hydrochloride
EP Impurity A dopamine NH2HO
HO
368. Dobutamine Hydrochloride
EP Impurity B 4-(4-hydroxyphenyl)butan-2-
one O OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
369. DOCETAXEL TRIHYDRATE
EP Impurity D
(10-dehydroxy-10-oxo-7epi-
docetaxel)
1,7α-dihydroxy-9,10-dioxo-5s,20-epoxytax-11-ene-
2α,4,13α- tetrayl 4-acetate 2-benzoate
13-[(2R,3S)3-[[(1,1-dimethylethoxy)carbonyl]ami
no]-2-hydroxy-3-phenylpropanoate]
370. DOCETAXEL TRIHYDRATE
EP Impurity C (7-epi-
docetaxel)
1,7α-10s-trihydroxy-9-oxo-5s,20-epoxytax-11-ene-
2α,4,13α- triyl 4-acetate 2-benzoate 13-
[(2R,3S)3-[[(1,1- dimethylethoxy)carbonyl]ami
no]-2-hydroxy-3- phenylpropanoate]
371. DOCETAXEL TRIHYDRATE
EP Impurity B (10-dehydroxy-
10-oxodocetaxel)
1,7 β-dihydroxy-9,10-dioxo-5 β,20-epoxytax-11-ene-2 α,4,13 α-triyl4-acetate2-
benzoate13-[(2R,3S)3-[[(1,1- dimethylethoxy)carbonyl]ami
no]-2-hydroxy-3-phenylpropanoate]
372. DOCETAXEL TRIHYDRATE
DOCETAXEL impurity
Benzenerropanoic acid, β-
[[(1,1-dimethylethoxy)
carbonyl]amino]-α-
hedroxy(2Ar,4S,4as,6R,9S,11S,
12as,12bs,)-12b-(acetyloxy)-
12(benzoyloxy)-
2a,3,4,4a,5,6,9,11,12,12a,12b-
dpdecajudrp-6,11-dojudrpxy-
4a,8,13,13-tetramethyl-5-oxo-
4-[[2,2-dichloroethoxy)
carbonyl]oxy]-7,11-methano-
1H-cyclodeca
[3,4]benz[1,2b]oxet-9-yl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
373. Domperidone EP Impurity A 5-chloro-1-(piperidin-4-yl)-1,3-
dihydro-2H-benzimidazol-2-one N
H
N
O
HN
Cl
374. Domperidone EP Impurity C
cis-4-(5-chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-[3-(2-oxo-2,3-dihydro-
1Hbenzimidazol-1-yl)propyl]piperidine 1-oxide
N+
O-
NH
N
O
HNN
O
Cl
375. Domperidone EP Impurity B 4-(5-chloro-2-oxo-2,3-dihydro-
1H-benzimidazol-1-yl)-1-formylpiperidine
NO
HNN
O
Cl
376. Donepezil N-oxide impurity
Donepezil N-Oxide impurity
O
N+O
O
-O
377. Donepezil EP Impurity A 2,3-dihydro-5,6-dimethoxy-2-((pyridin-4-yl)methyl)inden-1-
one
O
NO
O
378. Donepezil Donepezil EP Impurity
1-Benzyl-4-[3-(benzyloxy)- 5,6-dimethoxy-1H-2-
indenyl]methyl piperidine. N O
OO
379. Donepezil Donepezil EP Impurity
1-Benzyl-4-[(5,6-dimethoxy-1H-inden-
2yl)methyl]piperidine
N O
O
380. Donepezil Donepezil EP Impurity
5,6-Dimethoxy-2-(4-pyridyl)methyl-indan-1-one
O
N
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
381. Donepezil Donepezil EP Impurity
2,3-Dihydro-5,6-dimethoxy-2-[(4-pyridinyl)methylene-1H-
inden-1-one O
O
O
382. Donepezil Donepezil EP Impurity
1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-indan-2yl)methyl]piperidine
N O
O
383. Donepezil Donepezil EP Impurity
1,1-dibenzyl-4-[(5,6-
dimethoxy-1-oxo-2,3- dihydro-1H-inden-
2yl)methyl]piperidinium bromide
N+
O
O
O
384. Dronedarone Hydrochloride
N-Oxide Impurity
N-Butyl-N-(3-(4-(2-butyl-5-(methylsulfonamido)benzofur
an-3-carbonyl)phenoxy)propyl)buta
n-1-amine Oxide
385. Dronedarone Hydrochloride
N-Desbutyl Impurity
N-[2-Butyl-3-[4-[3-(butylamino)propoxy]benzoyl]
-5-benzofuranyl]methanesulfona
mide hydrochloride
386. Dronedarone Hydrochloride
Amino Impurity (5-Amino-2-butylbenzofuran-
3-yl)(4-hydroxyphenyl) methanone
387. Dopamine Hydrochloride
EP Impurity C 2-(3,4-
dimethoxyphenyl)ethanamine H2N
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
388. DORIPENEM MONOHYDRATE
DORIPENEM Impurity
4-NITROBENZYL (4R,5S,6S)-6-[(1R)-1-HYDROXYETHYL]-4-METHYL-3-[[(3S,5S)-1-(4-
NITROBENZYLOXYCARBONYL)-5-
(SULFAMOYLAMINOMETHYL)PYRROLIDIN-3-YL]THIO]-7-OXO-1-AZABICYCLO[3.2.0]HEPT-2-
ENE-2-CARBOXYLATE
N
O
O
O
SN
NH
SO
O NH2
O
ON+
O
O-
OH
N+
O
-O
H
389. DORIPENEM MONOHYDRATE
DORIPENEM Impurity
4-Nitrobenzyl(2S,4S)-2-{[aminosulfonyl)amino]methyl
]-4-mercaptopyrrolidine-1-carboxylate
N
O
O
SH
HN
SO
OH2N N+O
O-
390. DORIPENEM MONOHYDRATE
DORIPENEM Impurity
4-Nitrobenzyl(4R,5R,6S)-3-[(diphenylphosphono)oxy]-6-
[(R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-
2-ene-2-carboxylate NO
-O
OOH
OP
O
OO
N+O
-O
H
391. DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE Related
Compound A
((4R,6R)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-
thieno[2,3-b]thiopyran-2-sulfonamide-7,7-dioxide (R-R
ISOMER)
(R)
(R)
S S
OO
S
O
O
NH2
HN
392. DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE Related
Compound B
((4R,6S)-4-(Ethylamino)-6-methyl-5,6-dihydro-4H-
thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide
hydrochloride)
(S)
(R)
S S
OO
S
O
O
NH2
HN
393. DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE Acetyl impurity
((4S,6S)-4-(acetylamino)-5,6-dihydro-6-methyl-4H-
thieno[2,3-b]thiopyran-2-sulfonamide-7,7-dioxide
(S)
(S)
S S
OO
S
O
O
NH2
HNO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
394. Dosulepin Hydrochloride
EP Impurity B dibenzo[b,e]thiepin-11(6H)-
one
S
O
395. Doxazosin EP Impurity A (2RS)-2,3-dihydro-1,4-
benzodioxine-2-carboxylic acid
O
OO
HO
396. Doxazosin EP Impurity E 2,4-dichloro-6,7-
dimethoxyquinazoline
N
N
O
O
Cl
Cl
397. Doxazosin EP Impurity B 1-[(2RS)-2,3-dihydro-1,4-
benzodioxin-2-ylcarbonyl]piperazine
N
NH
O
O
O
398. Doxazosin EP Impurity G 6,7-dimethoxy-2-(piperazin-1-
yl)quinazolin-4-amine N
N
NH2
NHN
O
O
399. Doxazosin EP Impurity H 2,2’-(piperazine-1,4-
diyl)bis(6,7-dimethoxyquinazolin-4-amine)
N N
N
N
H2N
O
O
N
N
NH2
O
O
400. Doxazosin EP Impurity F 4-amino-2-chloro-6,7-dimethoxy quinazoline
N
N
O
O
Cl
NH2
401. Doxazosin Mesilate EP Impurity A (2RS)-2,3-dihydro-1,4-
benzodioxine-2-carboxylic acid
O
OO
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
402. Doxazosin Mesilate EP Impurity D 6,7-dimethoxyquinazoline-
2,4(1H,3H)-dione
HN
NH
O
O
O
O
403. Doxazosin Mesilate EP Impurity E 2,4-dichloro-6,7-
dimethoxyquinazoline
N
N
O
O
Cl
Cl
404. Doxazosin Mesylate Doxazosin
Related Compound B
6,7-dimethoxyquinazoline-2,4-dione
HN
NH
O
O
O
O
405. Doxazosin Mesylate Doxazosin
Related Compound C
2-chloro-4-amino-6,7-dimethoxyquinazoline
N
N
O
O
NH2
Cl
406. Doxazosin Mesylate Doxazosin
Related Compound D
1,4-benzodioxane-2-carboxylic acid
O
OO
HO
407. Doxazosin Mesylate Doxazosin
Related Compound E
2,4-dichloro-6,7-dimethoxyquinazoline
N
N
O
O
Cl
Cl
408. Doxepin Hydrochloride
EP Impurity A dibenzo[b,e]oxepin-11(6H)-
one (doxepinone)
O
O
409. Doxylamine Succinate
EP Impurity A N,N-dimethyl-2-[1(RS)-1-
phenyl-1-(pyridin-4-yl)ethoxy]ethanamine
410. Doxylamine Succinate
EP Impurity B (1RS)-1-phenyl-1-(pyridin-2-
yl)ethanol N
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
411. Doxylamine Succinate
EP Impurity D phenyl(pyridin-2-yl)methanone (2-benzoylpyridine)
O
N
412. DULOXETINE HYDROCHLORIDE
EP Impurity A (S)-N-Methyl-N-phenyloxy
carbonyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine. N
S
O
O
O
413. DULOXETINE HYDROCHLORIDE
EP Impurity (R,S)-N-Methyl-3-(1-Naphthyloxy)-3-(3-
thienyl)propanamine HN
SO
414. DULOXETINE HYDROCHLORIDE
EP Impurity (R-ISOMER)
(R)-N-methyl-3-(1-naphthyloxy)-3-(2-
thienyl)propanamine( R-ISOMER)
(R) HN
SO
415. Ebastine EP Impurity A diphenylmethanol
(benzhydrol), OH
416. Ebastine EP Impurity B 1-[4-(1,1-
dimethylethyl)phenyl]ethanone
O
417. Ecamsule Ecamsule Related
Compound A 1,4-Phenylenedimethanol
HO
OH
418. Ecamsule Ecamsule Related
Compound B
4-(hydroxymethyl)benzoic acid
O
HO
OH
419. Ecamsule Ecamsule Related
Compound C terephthalic acid
O
HO O
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
420. Ecamsule Ecamsule Related
Compound D
((1SR,4RS)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-
yl)methanesulfonic acid
421. Edetic Acid EP Impurity A nitrilotriacetic acid N
O
OH
O
OH
O
OH
422. Edrophonium Chloride
EP Impurity A 3-(dimethylamino)phenol N
HO
423. EFAVERINZ EFAVERINZ
Related Compound A
(S)-5-Chloro-alpha-(cyclopropyl ethynyl)-2-amino-
alpha-(trifluromethyl)-benzene methanol
OH
F
FFCl
NH2
424. EFAVERINZ EFAVERINZ Racemic Usp
(4RS)-6-Chloro-4-(cyclopropyl ethynyl)-1,4-Dihydro-4-
(trifluoromethyl)-2H-3,1- benzoxazin-2-one(RACEMIC
USP) NH
O
O
F
FF
Cl
425. EFAVERINZ EFAVERINZ Impurity
(S)-6-Chloro-4-pent-1-inyl-4-trifluoro methyl-1,4-
dihydrobenzo[d]-1,3-oxazin-one
NH
O
O
F
FF
Cl
426. EFAVERINZ EFAVERINZ
Related Compound B
((S,E)-6-Chloro-4-(2-Cyclopropylvinyl)-4-
(trifluoromethyl)-2H-3,1-benzoxazin-2-one)
HN O
O
F F
F
Cl
427. EFAVERINZ EFAVERINZ
Related Compound C
6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline
N
FF
F
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
428. ELETRIPTAN
HYDROBROMIDE ELETRIPTAN S-
Isomer
3-[[(2S)-1-methyl-2-pyrrolidinyl]methyl]-5-[2-
(phenyl sulfonyl)ethyl]-1H-indole(ent-Eletriptan) N
H
S
O
O
N(S)
429. EMTRICITABINE EMTRICITABINE Impurity
a) 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-
pyrimidinone, S-oxide
N
N
O
O
S
HO
F
NH2
O
430. EMTRICITABINE EMTRICITABINE Impurity
(2R,5S)-5-(4-amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-
[1,3]oxathiolane-2- carboxylic acid (1R,2S,5R)-
methyl ester
O
SO
O
NN
O
F
NH2
431. EMTRICITABINE EMTRICITABINE Impurity
(5S)-5-(4-Amino-5-fluoro-2-oxo-pyrimidine-1(2H)-yl)-1,3-
oxathiolane-2-carboxylic acid (emtricitabine acid)
O
S
O
HO
N
N
O
F
H2N
432. EMTRICITABINE EMTRICITABINE Impurity
5-Fluoro-1-(2-(hydroxymethyl)-1,3-
oxathiolane-5-yl) pyrimidine-2,4(1H, 3H)-dione.
(or) 2,3'-dideoxy-5-fluoro-3'-thiouridine
NH
N
O
OO
S
HO
F
433. EMTRICITABINE EMTRICITABINE Impurity
4-Amino-5-fluoro-1-[2-(hydrocymethyl)-1,3-
oxathiolan-5-yl]-2(1H)-Pyrimidinone((+)(-) Cis isomer)
N
N
O
O
S
HO
F
NH2
434. Enalapril Enalaprilat
impurity
(2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-
phenylpropyl]amino]propanoyl)pyrrolidine-2-carboxylic acid
435. Enalapril Maleate EP Impurity I 1H-imidazole N
HN
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
436. Enrofloxacin Enrofloxacin
Related Compound A
(-) 4-[(4-dimethylamino)-1-(4-fluorophenyl)-1-
(hydroxybutyl)]-3-(hydroxymethyl) benzonitrile
437. ENTACAPONE ENTACAPONE
Related Compound A
(2E)-2-Cyano-3-(3-methoxy-4-hydroxy-5-nitro phenyl)-N,N-
Diethyl-2-propenamide
O
N
N+O
-O
HO O
N
438. ENTACAPONE ENTACAPONE
Related Compound B
2-Cyano-N,N-diethylacetamide
O
N
N
439. EPROSARTAN MESYLATE
EPROSARTAN Impurity
2-Carbethoxy-3-(2-thienyl)sodium propionate
O ONa
S
O
O
440. EPROSARTAN MESYLATE
EPROSARTAN Impurity
4-[(2-Butyl-5-formyl-1H-imidazol-1-yl)methyl]benzoic
Acid O
HO
N
N O
441.
EPROSARTAN MESYLATE EPROSARTAN MESYLATE
EPROSARTAN Impurity
4-((2-butyl-5-((E)-2-carboxyvinyl)-1H-Imidazol-1-
yl)methyl)benzoic acid mesylate(Des[2-(2-
thienylmethyl)] Eprosartan)
O
OH
N
N
O
OH
HO
SO
O
442. EPROSARTAN MESYLATE
EPROSARTAN Impurity
4-((2-butyl-5-(2,2-dicarboxyvinyl)-1H-imidazol -
1-yl)methyl)benzoic acid(Des[2-(2-thienylmethyl)] Eprosartan-2-carboxylic Acid)
O
OH
N
N
O
OHO
HO
443. ERLOTINIB HYDROCHLORIDE
ERLOTINIB Impurity
6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)quinazolin-4-
amine.
N
N
HN
O
O
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
444. ERLOTINIB HYDROCHLORIDE
ERLOTINIB Impurity
6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)-N-(2-
methoxyethyl)quinazolin-4-amine
NN
N
O
O
O
OO
445. ERLOTINIB HYDROCHLORIDE
ERLOTINIB Impurity
4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline(Er
lotinib Chloro Impurity)
N
N
O
O
O
O
Cl
446. Erythritol EP Impurity A maltitol
447. Erythritol EP Impurity B sorbitol,
448. Erythritol EP Impurity D glycerol.
449. Escitalopram Escitalopram
Related Compound F
4-((E)-4-(dimethylamino)-1-(4-fluorophenyl)but-1-enyl)-3-(hydroxymethyl)benzonitrile
NOH
F
N
450. Escitalopram Escitalopram
Related Compound A
((-) 4-[(4-dimethylamino)-1-(4-fluorophenyl)-1-
(hydroxybutyl)]-3-(hydroxymethyl) benzonitrile)
NHO
F
N
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
451. Estradiol Estradiol Related
Compound C
1,3,5(10)-estratrien-3,17beta-diol-6-one
HO
OH
O
H
H
H
452. Estropipate EP Impurity A Estrone
HO
O
H
H
H
453. Etamsylate EP Impurity A benzene-1,4-diol (hydroquinone).
HO OH
454. Ethambutol Hydrochloride
EP Impurity A 2-aminobutan-1-ol OH
NH2
455. Ethinylestradiol EP Impurity C estrone
HO
O
H
H
H
456. Ethinylestradiol EP Impurity D estradiol
HO
OH
H
H
H
457. Ethyl Hydroxybenzoate
Ethyl 4-hydroxybenzoate
O
O
HO
458. Ethyl Hydroxybenzoate
EP Impurity A 4-hydroxybenzoic acid O
HO
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
459. Ethyl Hydroxybenzoate
EP Impurity B methyl 4-hydroxybenzoate
O
O
HO
460. Ethyl Hydroxybenzoate
EP Impurity C propyl 4-hydroxybenzoate
O
O
HO
461. Ethyl Hydroxybenzoate
EP Impurity D butyl 4-hydroxybenzoate O
O
OH
462. Ethyl Hydroxybenzoate Sodium
EP Impurity A 4-hydroxybenzoic acid O
HO
OH
463. Ethyl Hydroxybenzoate Sodium
EP Impurity B methyl 4-hydroxybenzoate
O
O
HO
464. Ethyl Hydroxybenzoate Sodium
EP Impurity C propyl 4-hydroxybenzoate
O
O
HO
465. Ethyl Hydroxybenzoate Sodium
EP Impurity D butyl 4-hydroxybenzoate O
O
OH
466. Etilefrine Hydrochloride
EP Impurity B (1RS)-1-(3-hydroxyphenyl)-2-
(methylamino)ethanol (phenylephrine)
NH
HO
OH
467. Etilefrine Hydrochloride
EP Impurity E 1-(3-hydroxyphenyl)ethanone
(3-hydroxyacetophenone)
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
468. Etilefrine Hydrochloride
EP Impurity F N-benzylethanamine (benzylethylamine).
HN
469. Etofenamate EP Impurity A flufenamic acid
470. Etofenamate EP Impurity C N-phenyl-3-
(trifluoromethyl)aniline NHF
F
F
471. ETORICOXIB EP Impurity C 1-(6-Methyl-3-pyridinyl)-2-[4-(methylsulfonyl)phenyl]ethan
one S
O
O
N
O
472. ETRAVIRINE ETRAVIRINE
Impurity
4-(6-Amino-5-bromo-2-[4-(aminocarbonyl)anilino]pyrimi
din-4-yloxy)-3,5-dimethyl benzamide
O
NH2
O
N
N
NH
O
H2N
BrH2N
473. ETRAVIRINE ETRAVIRINE
Impurity
4-(6-Amino-5-bromo-2-[(4-cyanophenyl)amino]pyrimidin-
4-yloxy) 3,5-dimethyl benzamide
O
NH2
O
N
N
NHN
BrH2N
474. ETRAVIRINE ETRAVIRINE
Impurity
4-(6-Amino-5-bromo-2-[(4-cyanophenyl)amino]pyrimidin-
4-yloxy) 3,5-dimethyl benzonitrile
N
O
N
N
NHN
BrH2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
475. ETRAVIRINE 6-Desamino 6-
Chloro Etravirine
4-(6-chloro-5-bromo-2-[(4-cyanophenyl)amino]-4-
pyrimidinyl]oxy]-3,5-dimethylbenzonitrile
N
O
N
N
NHN
BrCl
476. ETRAVIRINE EP Impurity C 4-(6-chloro-2-(4-cyanophenyl amino) pyrimidin-4-yloxy)-3,5-
dimethylbenzonitrile
N
O
N
N
NHN
Cl
477. Ezetemibe Des fluoro ezetimibe impurity
(3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-
phenylpropyl)-4-(4-hydroxyphenyl)azetidin-2-one
NO
HOHO
F
478. Ezetemibe Keto impurity of ezetimibe
Keto impurity of ezetimibe
479. Ezetemibe Des Alcohol impurity of ezetimibe
Des Alcohol impurity of ezetimibe
480. Ezetemibe Bis Des Fluoro
impurity of ezetimibe
Bis Des Fluoro impurity of ezetimibe
481. Ezetemibe Amide impurity
of ezetimibe Amide impurity of ezetimibe
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
482. Ezetemibe Benzyl
protected Ezetimibe
(3R,4S)-4-(4-(benzyloxy)phenyl)-1-(4-fluorophenyl)-3-((S)-3-(4-
fluorophenyl)-3-hydroxypropyl)azetidin-2-one
NO
OH
F
F
O
483. Ezetimibe RRS isomer of
Ezetimibe RRS isomer of Ezetimibe
484. Ezetimibe SSS isomer of
Ezetimibe SSS isomer of Ezetimibe
485. Ezetimibe RRR Isomer of
Ezetimibe RRR Isomer of Ezetimibe
486. Ezetimibe SRR isomer of
Ezetimibe SRR isomer of Ezetimibe
487. Ezetimibe RRS isomer of
Ezetimibe
(3S,4R)-1-(4-fluorophenyl)-3-((R)-3-(4-fluorophenyl)-3-
hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one
488. Ezetimibe SSR Isomer of
Ezetimibe SSR Isomer of Ezetimibe
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
489. Ezetimibe RSR Isomer of
Ezetimibe RSR Isomer of Ezetimibe
490. Ezetimibe
Benzyl Ezetimibe
Ketone impurity
(3R,4S)-4-(4-(benzyloxy)phenyl)-1-(4-
fluorophenyl)-3-[3-(4-fluorophenyl)-3-
oxopropyl]azetidin-2-one
N
O
O
F
F
O
491. Ezetimibe 4’-O-Benzyloxy
Ezetimibe Impurity
(3R,4S)-1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-(S)-
hydroxypropyl]-4-(4-benzyloxyphenyl)azetidin-2-
one
N
O
O
HO
F
F
492. Ezetimibe Ezetimibe Impurity
(2R,5S)-2-(4-Hydroxybenzyl)-N,5-bis(4-fluorophenyl)-5-
hydroxypentanamide O
HN
OH
F
F
OH
493. Ezetimibe (3’R)-Ezetimibe impurity
(3R,4S)-1-(4-fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-
hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one
N(R)
(S)
O
HO
(R)
HO
F
F
494. Ezetimibe Ezetimibe Impurity
(2R,3R,6S)-N,6-bis(4-fluorophenyl)-tetrahydro-2-(4-
hydroxyphenyl)-2H-pyran-3-carboxamide
O
O
HN
OH
F
F
495. FAMCICLOVIR FAMCICLOVIR Impurity
2-Amino-9(4-hydroxy-3-(hydroxyl methyl)butyl)-3H-
purin-6-one
N
NNH
N
O
OH
OH
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
496. FAMCICLOVIR FAMCICLOVIR
Impurity
2-[2-(2-Amino-9H-purin-9-yl)ethyl]-propane-1,3-diol
hydrochloride OH
OH
N
NN
N
H2N
497. FAMCICLOVIR FAMCICLOVIR
Impurity
2-[2-(2-Amino-6-chloro-9H-purin-9-yl)ethyl]-1,3-propane
diol diacetate
N
NN
N
Cl
H2N
O
O
OO
498. FAMCICLOVIR FAMCICLOVIR
Impurity 4-(2-Amino-9H-Purin-9-yl)-2-
(hydroxyl methyl)butyl acetate
O
OOH
N
NN
N
H2N
499. FAMCICLOVIR FAMCICLOVIR
Impurity
2-(Acetoxymethyl)-4-(2-amino-9H-Purin-9-yl)butyl
propionate O
O
N
NN
N
H2N
O O
500. Famotidine EP Impurity-F
3-[[[2-[(diaminomethylene) amino] thiazol-4-
yl]methyl]sulphanyl] propanoicacid
O
HO
SS
N N
NH2
NH2
501. Famotidine Famotidine
Related Compound-A
(3-[[2-(diaminomethyleneamino)thia
zol-4-yl]methylsulfinyl]-N'-sulfamoylpropanimidamide)
N
NH2
S
O
O
NH2S
O
S
NN
H2N
H2N
502. Famotidine EP Impurity A
3-[[[2-[(diaminomethylene)amino]th
iazol-4-yl]methyl]sulphanyl]propanim
idamide
HN
H2N
SS
N N
NH2
NH2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
503. Famotidine EP Impurity E 2,2’-
[disulphanediylbis(methylenethiazole-4,2-diyl)]diguanidine
504. Famotidine EP Impurity D
3-[[[2-[(diaminomethylene)amino]
thiazol-4-yl]methyl]sulphanyl] propanamide
O
H2N
SS
N N
NH2
NH2
505. Famotidine EP Impurity C
3-[[[2-[(diaminomethylene)amino]
thiazol-4-yl]methyl]sulphanyl]-N-sulphamoylpropanamide
O
NHS
O
O
H2N SS
N N
NH2
NH2
506. Felbinac EP Impurity A 4-acetyl biphenyl O
507. FELBAMATE FELBAMATE
Impurity 2-phenyl-1,3-propanediol
HO
OH
508. FEBUXOSTAT FEBUXOSTAT
Amide Impurity
2-(3-Carbamoyl-4-isobutoxyphenyl)-4-
methylthiazole-5-carboxylicacid
S
N
O
HO O
H2NO
509. FEBUXOSTAT FEBUXOSTAT
Ethyl ester Impurity
Ethyl2-(3-cyano-4-isobutoxyphenyl)-4-
methylthiazole-5-carboxylic acid
S
N
O
O O
N
510. Felodipine EP Impurity A
ethyl methyl 4-(2,3-dichlorophenyl)-2,6-
dimethylpyridine-3,5-dicarboxylate
511. Felodipine EP Impurity B
dimethyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-
1,4-dihydropyridine-3,5-dicarboxylate
NH
O O
O
O
ClCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
512. Felodipine EP Impurity C
diethyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-
dihydropyridine-3,5-dicarboxylate
NH
O O
O
O
ClCl
513. Fenbendazole Fenbendazole
Related Compound A
Methyl (1H-benzimidazole-2-yl)carbamate
NH
O
O
N
NH
514. Fenbufen EP Impurity C biphenyl
515. Fenofibrate EP Impurity A (4-chlorophenyl)(4-
hydroxyphenyl)methanone
O
OHCl
516. Fenofibrate EP Impurity B
2-[4-(4-chlorobenzoyl)phenoxy]-2-
methylpropanoic acid (fenofibric acid)
O
HO
O
O
Cl
517. Fenofibrate EP Impurity C (3RS)-3-[4-(4-
chlorobenzoyl)phenoxy]butan-2-one
O
O
O
Cl
518. Fenofibrate EP Impurity E ethyl 2-[4-(4-
chlorobenzoyl)phenoxy]-2-methylpropanoate
O
O
O
O
Cl
519. Fenofibrate EP Impurity F (4-chlorophenyl)[4-(1-
methylethoxy)phenyl]methanone
O
OCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
520. Fenofibrate EP Impurity D methyl 2-[4-(4-
chlorobenzoyl)phenoxy]-2-methylpropanoate O
O
O
O
Cl
521. Fenofibrate Fenofibrate
Related Compound A
(4-chlorophenyl)(4-hydroxyphenyl)methanone
O
OHCl
522. Fentanyl EP Impurity B N-phenyl-N-(piperidin-4-
yl)propanamide
O
N
NH
523. Fentanyl EP Impurity E benzaldehyde O
524. Fentanyl EP Impurity F aniline (phenylamine), H2N
525. Fentanyl EP Impurity G N-phenylpropanamide
O
HN
526. Fentanyl Fentanyl Related
Compound A (2-bromoethyl)benzene
Br
527. Fentanyl Citrate EP Impurity B N-phenyl-N-(piperidin-4-
yl)propanamide
O
N
NH
528. Fentanyl Citrate EP Impurity E benzaldehyde O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
529. FESOTERODINE FESOTERODINE
Impurity A
2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-
(hydroxymethyl) phenol HO
OH
N
530. FESOTERODINE FESOTERODINE
Impurity (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-methylphenol
N
OH
531. FESOTERODINE FESOTERODINE
Impurity
2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-
(methylphenyl)isobutyrate
O
O
N
532. FESOTERODINE FESOTERODINE
Impurity
2-((R)-3-(Diisoprpylamino)-1-phenypropyl)phenyl
isobutyrate O
O
N
533. FESOTERODINE FESOTERODINE
Impurity
(R)-3-(3-Diisopropylamino)-1-phenylpropyl)-4-
(isobutyryloxy)benzylisobutyrate
O
O
O
N
O
534. FESOTERODINE FESOTERODINE
Impurity
Isobutyic acid2-((S)-3-diisopropylammonium-1-
phenylpropyl)-4-hydroxymethyl)phenyl
ester(S-ISOMER) O
O
OH
(S)
N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
535. FESOTERODINE FESOTERODINE
Impurity
(R)-2-(3-Diisopropylamino)-1-phenylpropyl)-4-formylphenyl
isobutyrate
O
O
N
O
536. Fexofenadine Hydrochloride
EP Impurity E diphenyl(piperidin-4-
yl)methanol OH
NH
537. Fexofenadine Hydrochloride
Fexofenadine Related
Compound A
(4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-
piperidinyl]butyl]-alpha,alpha-dimethyl benzeneacetic acid)
O
HO
N
OH
O
538. Fexofenadine Hydrochloride
Fexofenadine Related
Compound B
2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piper
idin-1-yl]butyl]phenyl]-2-methylpropanoic acid
O
OH
N
OH
OH
539. Fexofenadine Hydrochloride
Fexofenadine Related
Compound C
(1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)
phenyl]butan-1-ol OH
N
OH
540. FINASTERIDE EP Impurity A (5alpha,17beta)-N-(1,1-
dimethyl ethyl)-3-oxo-4-aza androstane-17-carboxamide HN
O
HNO
HH
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
541. FINASTERIDE Finasteride
Impurity
(5alpha,17beta)-N-(cyclohexyl)-3-oxo-4-aza-5-
androst-1-ene-17-carboxamide
HN O
HNO
HH
H
H
542. FINASTERIDE EP Impurity B (5alpha,17beta)-Methyl 3-oxo-
4-aza-5-androst-1-ene-17-carboxylate
HN O
OO
HH
H
H
543. FINASTERIDE Finasteride
Impurity 1,3-Dicyclohexyl urea
NH
O
NH
544. Flavoxate Hydrochloride
EP Impurity A 3-methyl-4-oxo-2-phenyl-4H-
1-benzopyran-8-carboxylic acid O
OHO
O
545. Fluconazole EP Impurity D 2-(4-fluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol HO
N
NN
N
N N
F
546. Fluconazole EP Impurity A (2RS)-2-(2,4-difluorophenyl)-1-
(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol
HO
NN
N
N
NN
F
F
547. Fluconazole EP Impurity C 1,1’-(1,3-phenylene)di-1H-
1,2,4-triazole NN
N
N
NN
548. Fluconazole EP Impurity B 2-[2-fluoro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-
triazol-1-yl)propan-2-ol HO
N
NN
N
NN
NN
N
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
549. Flumazenil Flumazenil
Related Compound C
N,N-Dimethylformamide diethyl acetal
N
OO
550. Flunarizine EP Impurity A 1-[bis(4-
fluorophenyl)methyl]piperazine
NHN
F
F
551. Flunarizine EP Impurity B
1-[(RS)-(4-fluorophenyl)phenylmethyl]-
4-[(2E)-3-phenylprop-2-enyl]piperazine
N
NF
552. Flunarizine EP Impurity C
1-[(RS)-(2-fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)-
3-phenylprop-2-enyl]piperazine
N
NF
F
553. Fluoxetine Hydrochloride
Fluoxetine Related
Compound A
N-methyl-3-phenyl-3-[(alpha,alpha,alpha-(trifluoro-
m-tolyl)oxy]propylamine hydrochloride
554. Fluoxetine Hydrochloride
Fluoxetine Related
Compound A
3,3-pentamethylene-5-butyrolactam
555. FLUVASTATIN SODIUM
FLUVASTATIN (3R,5R Isomer)
[R*,R*-(E)]-±-7-[3-(4-Fluorophenyl)-1-(1-
methylethyl)-1H-indol-2yl]-3,5-dihydroxy-6-heptenoic
acid((3R,5R)-Fluvastatin Sodium Salt)
(R)(R)
O
HOHOHO
N
F
(E)
556. FLUVASTATIN SODIUM
FLUVASTATIN Methyl ester
Methy(±)-erythro-E-3,5-dihydroxy-7-[3'-4"-
fluorophenyl)-1'-(1"-methylethy)-indol-2'-yl]hept-
6-enoate (R)
(S)
O
OHOHO
N
F
(E)
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
557. FROVATRIPTAN SUCCINATE
FROVATRIPTAN S-Isomer
(3S)-2,3,4,9-Tetrahydro-3-(methylamiano)-1H-carbazole-
6-carboxamide(ent-Frovatriptan)
NH
(S)
O
NH2
HN
558. Fluticasone EP Impurity F
6a,9-difluoro-17-[[(fluoromethyl)sulphanyl]carb
onyl]-16a-methyl-3,11-dioxoandrosta-1,4-dien-17a-yl
propanoate
O
OO
O
OS
F
F
F
559. FOSINOPRIL SODIUM
EP Impurity D [(2-Methyl-1-(1-oxopropoxy)
propoxy)(4-phenylbutyl)-phosphinyl]acetic acid
O
HO
P
O
O
O O
560. Fosaprepitant dimeglumine
Fosaprepitant Impurity
5-(((2R,3S)-2-((R)-1-(3,5-bis(trifluoromethyl)phenyl)eth
oxy)-3-(4-fluorophenyl)morpholino)methyl)-1,2-dihydro-1,2,4-triazol-
3-one
NHHN
NON
O
F
O
F
FF
F
F
F
561. Fosaprepitant dimeglumine
Fosaprepitant Impurity
Benzyl hydrogen3-(((2R,3S)-2((R)-1-(3,5-
bis(trifluoromethyl)phenyl)ethoxy)-3-(4-fluorophenyl)-4-
morpholino)methyl)-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-
ylphosphonate
NN
HN
PO
OH
O
OO
N
F
O
F
F
F
F
FF
562. FLUVASTATIN SODIUM
FLUVASTATIN Methyl ester
impurity
Methyl(±)-erthro-E-3,5-dihydroxy-7-[3'(4'-fluorophenyl)-1-
(1'methylethyl)-indol-2'-yl]hept-6-enoate
O
OHOHO
N
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
563. GABAPENTIN GABAPENTIN
Impurity Cyclohexane-1,1-diacetic acid
O
OH
O
OH
564. GABAPENTIN GABAPENTIN
Impurity 2-[1-(Carbamoyl
methyl)cyclohexyl]acetic acid.
O
OH
H2N
O
565. GANCICLOVIR GANCICLOVIR
Impurity 2-Amino -1H-purin-6(9H)-one.
N
NH
N
HN
O
H2N
566. GANCICLOVIR GANCICLOVIR
Impurity
2-Amino-7-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-1,7-dihydro-6H-Purin-6-one
N
N
N
HN
O
O
HO
OHH2N
567. GEFITINIB GEFITINIB Impurity
N-(3,5-dichloro-4-fluoro phenyl)-7-methoxy-6-(3-
morpholin-4-ylpropoxy)quinazolin-4-amine
N
N
HN
ON
O
O
F
Cl
Cl
568. GEFITINIB GEFITINIB Impurity
3-chloro-4-fluoro aniline NH2
F
Cl
569. GEFITINIB GEFITINIB Impurity
7-Methoxy-6-(3-morpholinopropoxy)-3,4-di
hydro-4-quinazolinone
N
NH
O
O
O
N
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
570. Gemcitabine 5-O-Acetyl
gemcitabin(IH) 5-O-Acetyl gemcitabin(IH)
impurity
571. Gemcitabine Gemcitabine
Impurity
2'-Deoxy-2';2'-difluorocytidine.(alpha-
Anomer)
572. Gemcitabine Gemcitabine
Impurity 4-Aminopyrimidin-2(1H)-one
N
NH
OH2N
573. Gemcitabine Hydrochloride
EP Impurity A 4-aminopyrimidin-2(1H)-one
(cytosine), N
NH
OH2N
574. Gemfibrozil Gemfibrozil
Related Compound A
(E,Z)-2,2-dimethyl-5-[2,5-dimethyl-4-(propene-1-yl)phenoxy]valeric acid
O
HO
O
575. Glibenclamide EP Impurity A 5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benza
mide
O
HNS
O
O
NH2
O
Cl
576. Glibenclamide EP Impurity B
(methyl-[[4-[2-[(5-chloro-2-methoxybenzoyl)-
amino]ethyl]phenyl]sulfonyl]carbamate)
NHO
O
S
O
O
HN
OO
Cl
577. Glibenclamide EP Impurity C Glibenclamide Impurity C
HN
O
HNS
O
O
NH
NH
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
578. Gliclazide EP Impurity A 4-
methylbenzenesulphonamide S
O
O
NH2
579. Glimepride Glimepride
Related Compound B
Glimepiride Sulfonamide N
O
NH
S
O
O
H2N
O
580. Glimepride Glimepride
Related Compound C
Glimepiride urethane N
O
HN
S
O
O
NH
O
O
O
581. Glimepride Glimepride Impurity
Methyl[[4-[2-[[3-ethyl-4-methyl-2-oxo-2,3-dihydro-1H-
pyrrole-1-yl)carbonyl]amino]ethyl]phen
yl]sulphonyl]carbamate
N
O
NH
OS
O
O HN
O
582. Glimepride Glimepride
Related Compound A
1-[[4-[2-[[(3-ethyl-4-methyl-2-oxo-2,3-dihydro-1H-Pyrrol-1-yl)carbonyl]amino]ethyl]phen
yl]sulphonyl]3-(cis-4-methylcyclohexyl)urea
HN
O
HNS
O
O
NH
O
N
O
583. Glipizide EP Impurity A
5-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyraz
ine-2-carboxamide
N
N
ONH
S
O
O
H2N
584. Glipizide EP Impurity B cyclohexanamine H2N
585. Glyburide Glyburide Related
Compound A
5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benza
mide
O
HNS
O
O
NH2
O
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
586. Glyburide Glyburide Related
Compound B
(methyl-[[4-[2-[(5-chloro-2-methoxybenzoyl)-
amino]ethyl]phenyl]sulfonyl]carbamate)
NHO
O
S
O
O
HN
OO
Cl
587. Glycerol
Propane-1,2,3-triol OH
OH
HO
588. Glycerol EP Impurity A 2,2'-oxydiethanol (diethylene
glycol), O
HO OH
589. Glycerol EP Impurity B ethane-1,2-diol (ethylene
glycol), HO
OH
590. Granisetron Granisetron
Related Compound D
1-methyl-1H-indazole-3-carboxylic acid
NN
OOH
591. Granisetron Hydrochloride
EP Impurity H 1H-indazole-3-carboxylic acid
HN
N
O
HO
592. Guaiacol
2-Methoxyphenol O
OH
593. Guaiacol EP Impurity A benzene-1,2-diol (pyrocatechol), HO
HO
594. Guaiacol EP Impurity B phenol HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
595. Guaiacol EP Impurity C 1,2-dimethoxybenzene
(veratrole), O O
596. Guaiacol EP Impurity D 2,5-dimethoxyphenol O O
OH
597. Guaiacol EP Impurity E methyl benzoate
O
O
598. Guaifenesin EP Impurity A 2-methoxyphenol (guaiacol), O
OH
599. Hexylresorcinol EP Impurity A phenol, HO
600. Hexylresorcinol EP Impurity B resorcinol OHHO
601. HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE Impurity
1-phthalazinone N
N
O
602. HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE Impurity
2-formylbenzoic acid O
HO
O
603. HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE Impurity
1-clorophthalazine N
N
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
604. Hydrochlorothiazide EP Impurity A chlorothiazide
605. Hydrochlorothiazide EP Impurity B 4-amino-6-chlorobenzene-1,3-
disulphonamide (salamide), S
O
ONH2
S
O
O
H2N
ClH2N
606. Hydroxyethyl Salicylate
EP Impurity A salicylic acid
HO
O
HO
607. Hydroxyethyl Salicylate
EP Impurity B ethane-1,2-diol (ethylene
glycol). HO
OH
608. Hydroxyzine Hydrochloride
EP Impurity A (RS)-1-[(4-
chlorophenyl)phenylmethyl]piperazine
NHN
Cl
609. Hydroxyzine Hydrochloride
EP Impurity B
2-[2-[4-(diphenylmethyl)piperazin-1-
yl]ethoxy]ethanol (decloxizine)
ON
N
OH
610. Hydroxyzine Hydrochloride
Hydroxyzine Related
Compound A p-Chlorobenzhydrylpiperazine
611. Hymecromone EP Impurity A resorcinol OHHO
612. Ibuprofen EP Impurity E 1-[4-(2-
methylpropyl)phenyl]ethanone
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
613. Ifosfamide EP Impurity C 2-chloroethanamine H2NCl
614. Ifosfamide EP Impurity D 2-aminoethanol NH2
HO
615. IMATINIB MESYLATE
IMATINIB Impurity
N-(2-methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine-
amine N
N
NH
N
H2N
616. IMATINIB MESYLATE
IMATINIB Impurity
N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]-
amino]phenyl]4-methylbenzamide methanusulfonate
O
NH
NH
N
N
N
SO
OHO
617. IMATINIB MESYLATE
IMATINIB Impurity
Benzoic acid,4-[(4-methyl -1-piperazinyl)methyl]dihydrochl
orde
O
OH
NN
618. Indapamide EP Impurity A (2RS)-2-methyl-1-nitroso-2,3-
dihydro-1H-indole NN
O
619. Indometacin EP Impurity A 4-chlorobenzoic acid O
HO
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
620. Indoramin Hydrochloride
EP Impurity A 3-(2-bromoethyl)indole
HN
Br
621. Indoramin Hydrochloride
EP Impurity B N-(1-benzyl-4-
piperidyl)benzamide ON
H
N
622. Indoramin Hydrochloride
EP Impurity C N-(4-piperidyl)benzamide
O
HN NH
623. Indapamide Indapamide
Impurity Chlorosulfonyl benzoic acid
O
HO
SO O
NH2
Cl
624. Indapamide Indapamide
Dehydro impurity
4-chloro-N-(2-methyl-indol-1-yl)- 3-sulfamoyl-benzamide
O
NH
SO O
NH2
N
Cl
625. Ipratropium Bromide
Ipratropium Bromide Related
Compound C
(2-RS)-3-hydroxy-2-phenylpropanoic acid
626. Irbesartan Irbesartan
Related Compound A
(1-pentanoylamino-cyclopentanecarboxylic acid
[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amide)
O
NH
HN
N N
NNH
O
627. Irbesartan Irbesartan Impurity
4-Bromomethyl-2'-cyanobipheny
CNBr
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
628. Irbesartan Irbesartan Impurity
triphenyl methane
629. Irbesartan Irbesartan Impurity
2-propyl-3-[[2'(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4,4]non-1-en-4-
one
NN
O
HN
N N
N
630. Irbesartan Irbesartan Impurity
triphenyl methanol OH
631. Irbesartan Irbesartan Impurity
1-[(2''- Cyanobiphenyl-4-yl)) methyl]-2-n-butyl-4-Spirocyclopentane-2-
Imidazolin-5-one
NN
O
CN
632. Irinotecan Irinotecan
Related Compound A
(S)-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2
-b]quinoline-3,14(4H,12H)-dione N
NO
O
O
OHHO
633. Irinotecan Irinotecan
Related Compound
(4S)-4,11-Diethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]
indolizino [1,2-b]quinoline-3,14(4H,12H)-dione
N
NO
O
O
OHHO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
634. ITRACONAZOLE EP Impurity A
4-[4-[4-(4-methoxyphenyl)piperazin-1-
yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-
1,2,4-triazol-3-one
N
NN
O
NNO
635. ITRACONAZOLE EP Impurity B
4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(4H-1,2,4-
triazol-4-ylmethyl)-1,3-dioxolan-4-yl]
methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-
methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one
N
NN
O
N N O O
O
NN
N
Cl
Cl
636. ITRACONAZOLE EP Impurity C
4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-
triazol-1-ylmethyl)-1,3-dioxolan-4-yl]
methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl-2,4-
dihydro-3H-1,2,4-triazol-3-one
N
N N
O NN
O
O
O
N
NN
ClCl
637. ITRACONAZOLE EP Impurity D
4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-
triazol-1-ylmethyl)-1,3-dioxolan-4-yl]
methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-methylethyl)-
2,4-dihydro-3H-1,2,4-triazol-3-one
N
N N
O NN
O
O
O
N
NN
ClCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
638. ITRACONAZOLE EP Impurity E
4-[4-[4-[4-[[trans-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-
triazol-1-ylmethyl)-1,3-dioxolan-4-yl]
methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-
methylpropyl]-2,4-dihydro-3H-1,2,4-
triazol- 3-one
N
N N
O NN
O
O
O
N
NN
ClCl
639. ITRACONAZOLE EP Impurity F
2-butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-
triazol-1-ylmethyl)-1,3-dioxolan-
4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-3H-
1,2,4-triazol-3-one
N
N N
O
NN
O O
O
N
NN
ClCl
640. ITRACONAZOLE EP Impurity G
4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-
triazol-1-ylmethyl)-1,3-dioxolan-4-yl]
methoxy]phenyl]piperazin-1-yl]phenyl]-2-[[cis-2-(2,4-
dichlorophenyl)-2-(1H-1,2,4-triazol-1-
ylmethyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro-3H-
1,2,4-triazol-3-one
N
NN
O
O
O
NN
N
ClCl
NNOO
O
N
N N
Cl
Cl
641. LACOSAMIDE LACOSAMIDE
Impurity
(R)-2-Amino-N-benzyl-3-methoxy propanamide (N-
Desacetyl Lacosamide) O
HN
O
NH2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
642. LACOSAMIDE LACOSAMIDE
Impurity
(2S)-2-(Acetylamino)-3-methoxy-N-
(phenylmethyl)prapanamide
O
HN
OHN
O
643. Lamotrigine Lamotrigine
Related Compound D
2-(10,11-Dihydro-10-oxodibenzo[b,f]thiepin-2-
yl)propionicacid O
HN
Cl Cl
NN
N
ClClNH2
644. Lamotrigine Lamotrigine
Related Compound B
2,3-dichlorobenzoic acid
O
HO
ClCl
645. LAMIVUDINE LAMIVUDINE
Impurity
4-Amino-1-[(2R,3S,5S)-2-(hydroxymethyl)-1,3-
oxathiolan-5-yl]pymidin-2(1H)-ONE S-Oxide
N
O
O
S
HONH2
O
646. Lansoprazole EP Impurity E 1H-benzimidazole-2-thiol
N
HN
HS
647. Lansoprazole EP Impurity B
2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-
yl]methyl]sulphonyl]-1Hbenzimidazole
N
NH
S
O
O N
O
F
FF
648. Lansoprazole EP Impurity D 1H-benzimidazol-2-ol
N
HN
HO
649. Lansoprazole EP Impurity E 1H-benzimidazole-2-thiol
N
HN
HS
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
650. Lansoprazole EP Impurity C
2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-
yl]methyl]sulphanyl]-1Hbenzimidazole
N
NH
S
N
OF
FF
651. Lansoprazole EP Impurity F
2-[(RS)-[(4-chloro-3-methylpyridin-2-
yl)methyl]sulphinyl]-1H-benzimidazole
N
NH
S
O
N
Cl
652. Lansoprazole EP Impurity A
2-[(RS)-[[3-methyl-1-oxido-4-(2,2,2-trifluoroethoxy)pyridin-
2-yl]methyl]sulphinyl]-1H-benzimidazole
N
NH
S
O N
OF
F
F
-O
653. Lansoprazole Dexlansoprazol
e Isomer of lansoprazole
654. Lansoprazole Leflunomide
Related Compound A
4-(trifluoromethyl)aniline H2N
F
F
F
655. LAPATINIB LAPATINIB Impurity
N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]
-6-[5-[[[-2-(methylsulphenyl)ethyl]imino]
methyl]-2-furanyl]-4-quinazoliamine
N
N
NH
O
N S
O
F
Cl
656. LAPATINIB LAPATINIB Impurity
5-[4-[3-chloro-4-[(3-fluorobenzyloxy)aniline]-6-
quinazolinyl]furan-2-carbaldehyde
N
N
NH
O
O
O
F
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
657. LAPATINIB LAPATINIB
Dimer Impurity
N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-
((((5-(4-(3-chloro-4-(3-fluorobenzyloxy)phenylamino)
quinazolin-6-yl)furan-2-yl)mehtyl)(2-
(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine( DIMER IMPURITY)
N
N
NH
O
NS
O
OO
N
N
HN
OF
Cl
O
F
Cl
658. Latanoprost Latanoprost acid Impurity
Latanoprost acid
659. Leflunamide Leflunomide
Related Compound A
4-(trifluoromethyl)aniline H2N
F
F
F
660. Leflunamide Leflunomide
Related Compound B
2-Cyano-3-hydroxy-N-(4'-trifluoromethylphenyl)-
crotone amide
661. Leflunamide Leflunomide
Related Compound C
N-(3'-Trifluoromethylphenyl)-5-methylisoxazole-4-
carboxamide
O
N
O
HN
FF
F
662. Leflunomide EP Impurity A 4-(trifluoromethyl)aniline H2N
F
F
F
663. Leflunomide EP Impurity D 5-methylisoxazole-4-
carboxylic acid O
N
O
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
664. Lenalidomide Lenalidomide
Impurity
N-(2-(2,6-Dioxopiperdin-3-yl)-1-oxoisoindolin-4-
yl)formamide(Formyl Lenalidomide)
O
HN
N
O
HN
O
O
665. LERCANIDIPINE HYDROCHLORIDE
LERCANIDIPINE Impuritry
2,6-Dimethyl-5-methyoxy carbonyl-4-(3-nitrophenyl)-
1,4-dihydropyridine-3-carboxylic acid HN
OOH
N+OO-
O
O
666. LERCANIDIPINE HYDROCHLORIDE
LERCANIDIPINE Impuritry
1-[(3,3-Diphenylpropyl)methylamino]
-2-methyl-2-propanol OH
N
667. LETROZOLE LETROZOLE
Related Compound B
4,4',4''-Methylidenetrisbenzonitrile
NN
N
668. Levetiracetam EP Impurity D (2R)-2-(2-oxopyrrolidin-1-
yl)butanamide
O
H2N
N
O
669. Levetiracetam USP Related Compound A
(S)-N-(1-amino-1-oxobutan-2-yl)-4-chlorobutanamide
O
NH
Cl
O
NH2
670. Levetiracetam EP Impurity A 2-(2-oxopyrrolidin-1-
yl)butanoic acid
O
HO
N
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
671. Levetiracetam Levetiracetam
Related Compound B
(S)-2-aminobutanamide hydrochloride
O
H2N
H2N
H Cl
672. Levetiracetam Levetiracetam
R-ISOMER
(alpha R)- alpha-Ethyl-2-oxo-1-pyrrolidine acetamide( R-
ISOMER) N(R)
O
H2N
O
673. Levetiracetam Levetiracetam
Impurity (R)-(+)-alpha-Methyl-benzyl
amine H2N
(R)
674. Levetiracetam Levetiracetam
Metabolite (S)-2-(2-Oxopyrrolidin-1-
yl)butanoic acid O
HO N
O
675. Levetiracetam EP Impurity C 2-Hydroxy pyridine N
HO
676. Levodopa EP Impurity A (2S)-2-amino-3-(2,4,5-
trihydroxyphenyl)propanoic acid
O
OHHO
HO OHNH2
677. Levodopa EP Impurity B (2S)-2-amino-3-(4-
hydroxyphenyl)propanoic acid (tyrosine)
O
HO
OH
NH2
678. Levodopa Levodopa Related
Compound B 3-methoxytyrosine
NH2
HO O OH
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
679. Levodropropizine EP Impurity B 1-phenylpiperazine NHN
680. Levodropropizine EP Impurity C [(2RS)-oxiran-2-yl]methanol
(glycidol). HO O
681. Levofloxacin EP Impurity A
(S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-
Pyrido[1,2,3-de][1,4]benzoxazine-6-
carboxylic acid (Levofloxacin Difluoro Impurity
O
N
O
OH
O
F
F
682. Levofloxacin EP Impurity B
9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-
benzoxazine(Decarboxylated Levofloxacin)
O
N
O
N
N
F
683. Levofloxacin EP Impurity C
(3S)-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-
de]-1,4- benzoxazine-6-carboxylic
acid(9-Desfluoro Levofloxacin) O
N
O
OH
O
N
N
684. Levofloxacin EP Impurity D
(S)-10-Fluoro-2,3-dihydro-3-methyl-9-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-
benzoxazine-6-carboxylic Acid(9-Piperazino Levofloxacin
Impurity)
O
N
O
HO
O
N
N
F
685. Levofloxacin EP Impurity E
(S)-9-fluoro-3-mehyl-10(piperazine-1-yl)-7-oxo-2,3-
dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-
carboxylic acid
N
O
O
OH
N
HN
O
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
686. Levofloxacin EP Impurity F
4-[(3S)-6-carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-
pyrido[1,2,3-de]-1,4- benzoxazin-10-yl]-1-
methylpiperazine 1-oxide N+
N
O
N
O
F
O
OH
-O
687. Levofloxacin
(+)-Ofloxacin; (R)-(+)-
Ofloxacin; D-Ofloxacin; d-Levofloxacin , R-levofloxacin
(3R)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-
benzoxazine-6-carboxylic Acid O
(R)
N
O
OH
O
N
N
F
(E)
688. Levofloxacin Levofloxacin
Related Compound B
(S)-9,10,difluro-3-methyl-7-oxo-2,3-dihydro-7H-
pyrido[1,2,3-de][1,4]benzoxazine-6-
carboxylic acid
O
N
O
HO
O
F
F
689. Levomepromazine Maleate
EP Impurity A 2-methoxyphenothiazine
S
NH
O
690. Levomethadone Hydrochloride
EP Impurity E diphenylacetonitrile
N
691. Lidocaine EP Impurity A 2,6-dimethylaniline H2N
692. Lidocaine EP Impurity B 2-(diethylazinoyl)-N-(2,6-
dimethylphenyl)acetamide (lidocaine N-oxide)
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
693. Lidocaine EP Impurity G N-(2,6-dimethylphenyl)-2-((1-
methylethyl)amino) acetamide
O
NH
HN
694. Lidocaine EP Impurity H 2-chloro-N-(2,6-
dimethylphenyl)acetamide
O
NH Cl
695. Lidocaine EP Impurity C N-(2,6-
dimethylphenyl)acetamide O
NH
696. Liothyronine Sodium
EP Impurity A levothyroxine
697. Lisinopril Dihydrate EP Impurity A (2RS)-2-amino-4-
phenylbutanoic acid O
OH
H2N
698. Lisinopril Dihydrate EP Impurity B 4-methylbenzenesulphonic
acid S
O
O
OH
699. Lisinopril Dihydrate EP Impurity E R,S,S ISOMER
(2S)-1-[(2S)-6-amino-2-[[(1R)-1-carboxy-3-
phenylpropyl]amino]hexanoyl]pyrrolidine-2-
carboxylic acid (lisinopril R,S,S-isomer)
N (S)
O
OH
(S) ONH
(R)
O OH
H2N
700. Lisinopril Dihydrate Lisinopril Impurity
Trifluoro acetyl L-lysine N
H2N
O OH
O
F
F
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
701. Lisinopril Dihydrate Lisinopril Impurity
(S)-1-Carboxy-3-phenylpropyl-L-lysine
HN NH2
O OH
O
OH
702. Lobeline Hydrochloride
EP Impurity D acetophenone O
703. Lofepramine Hydrochloride
EP Impurity B 4-chlorobenzoic acid O
HO
Cl
704. Lofepramine Hydrochloride
EP Impurity D iminodibenzyl
705. Lofepramine Hydrochloride
EP Impurity G imipramine
706. Lomustine EP Impurity C 1,3-dicyclohexylurea NH
O
NH
707. Loperamide Hydrochloride
EP Impurity C 4-(4-chlorophenyl)piperidin-4-
ol HN
OH
Cl
708. Loprazolam Mesilate
EP Impurity B N-methylpiperazine N NH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
709. LOPINAVIR LOPINAVIR
Impurity
(2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino
-3-hydroxy-5-triflurormethyl carbonylamino-1,6-
diphenylhexane.
710. LOPINAVIR LOPINAVIR
Impurity
(2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino
-3-hydroxy-5- amino 1,6-diphenyl hexane
NH2
OH
NH
O
O
711. LORNOXICAM LORNOXICAM
Impurity 2-Amino pyridine
N
H2N
712. LORNOXICAM LORNOXICAM
Impurity
6-Chloro-4-hydroxy-2-methoxycarbonyl-2H-
Thieno[2,3-e]-1,1-dioxide
SN
S
O
O O
O
Cl O
713. Loratadine EP Impurity B 8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-
b]pyridin-11-one
N
O
Cl
714. Loratadine EP Impurity D
8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-
b]pyridine
N
HN
Cl
715. Loratadine EP Impurity G
8-chloro-11-(1-methylpiperidin-4-ylidene)-
6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-
b]pyridine
N
N
Cl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
716. Loratadine EP Impurity H ethyl 4-oxopiperidine-1-
carboxylate N
O
O
O
717. Loratadine Loratadine N-
formyl impurity Loratadine N-formyl impurity
N
N
Cl
O
718. Loratadine Loratadine N-
Acetyl impurity Loratadine N-Acetyl impurity
N
N
Cl
O
719. Loratadine Bromodesloratadine impurity
Bromodesloratadine impurity
NH
N
Br
720. Loratadine Loratadine
Related Compound A
8-Chloro-6,11-dihydro-11(4-piperidinylidene)-5H-
benzo[5,6]cyclohepta[1,2-b] pyridine
N
HN
Cl
721. Loratadine Lorazepam
Related Compound B
2-Amino-2',5-dichlorobenzophenone
O
Cl
Cl
NH2
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
722. Lorazepam EP Impurity A (2-amino-5-chlorophenyl)(2-
chlorophenyl)methanone
O
Cl
Cl
NH2
723. Lormetazepam EP Impurity A 2-methylamino-2¢,5-
dichlorobenzophenone
724. LOSARTAN POTASSIUM
LOSARTAN Related
Compound A
4'-[(2-butyl-4-chloro-5-formyl-1H-imidazol-1-yl)methyl]-[1,1'-
biphenyl]-2-carbonitrile N
N
N
O
Cl
725. LOSARTAN POTASSIUM
LOSARTAN Related
Compound B
4'-[(2-Butyl-4-chloro-5-(hydroxymethyl)-1H-Imidazol-1-yl)methyl]-[1,1'biphenyl]-2-
carbonitrile N
N
N
OH
Cl
726. LOSARTAN POTASSIUM
LOSARTAN Related
Compound
2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-
yl]-methyl-1H-imidazole-5-carboxylic acid
OH
N
NNH
NN
NCl
O
727. Lovastatin EP Impurity A
(1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-
pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-
hexahydronaphthalen-1-yl (2S)-2-methylbutanoate
(mevastatin),
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
728. Lovastatin EP Impurity B
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-
2methylbutanoyl]oxy]-1,2,6,7,8,8ahexahydronaphtha
len-1-yl]-3,5-dihydroxyheptanoic acid (hydroxyacid lovastatin)
729. Lovastatin EP Impurity C
(1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-
1,2,3,7,8,8a-hexahydronaphthalen-1-yl
(2S)-2-methylbutanoate (dehydrolovastatin)
730. Maraviroc Maraviroc R-
Isomer
4,4-Difluoro-N-[(1R)-3-[(3-exo)-3-[3-methyl-5-(1-
methylethyl)-4H-1,2,4-triazol-4-yl]-8-azabicyclo[3.2.1]oct-8-
yl]-1-phenylpropyl}cyclohexanecarb
oxamide(R-Isomer)
O
NH
(R)
NN
NN
FF
H
731. Maraviroc Maraviroc Impurity
Tert-butyl(1S)-3-[3-(Isopropyl-5-methyl-4H-1,2,4-triazol-4-
yl]-exo-8-azabicyclo[3.2.1]oct-8-yl)-1-
phenylpropylacarbamate
O
O
NH
(S)
NN
NN
H
732. Maraviroc Maraviroc Impurity
4,4-Difluoro-N-[(1S)-3-[(3-endo)-3-[3-methyl-5-(1-
methylethyl)-4H-1,2,4-triazol-4-yl]-8-azabicyclo[3.2.1]oct-8-
yl]-1-phenylpropyl]-cyclohexanecarboxamide(End
o MARAVIROC)
O
NH
(S)
NN
NN
FF
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
733. Maraviroc Maraviroc Impurity
N-((S)-3-((1R, 3R, 5S)-3-(3, 5-diisopropyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1.]octan-
8-yl)-1-phenylpropyl)-4,4-difluorocyclohexanecarboxami
de
O
NH
FF
NN
NN
H
H
734. Meloxicam Meloxicam
Related Compound A
4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylic acid ethyl ester 1,1-dioxide
735. Meloxicam Meloxicam
Related Compound B
2-Amino-5-methyl-thiazole S
N
H2N
736. Memantine 1-methyl
adamantine 1-methyl adamantine
737. Memantine EP Impurity D 1-Methyl Adamanatane
738. Memantine 3,5-dimethyl-1-adamantanol
3,5-dimethyl-1-adamantanol
739. Memantine 1-Chloro-3,5-
dimethyl adamantanal
1-Chloro-3,5-dimethyl adamantanal
740. Memantine Adamantane
impurity Adamantane impurity
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
741. Mesalazine EP Impurity A 4-aminophenol NH2HO
742. Mesalazine EP Impurity B 3-aminophenol H2N OH
743. Mesalazine EP Impurity C 2-aminophenol
H2N
HO
744. Mesalazine EP Impurity D 3-aminobenzoic acid O
HO
NH2
745. Mesalazine EP Impurity E 4-amino-2-hydroxybenzoic acid (4-aminosalicylic acid)
O
HO
NH2
OHO
O
NH2
746. Mesalazine EP Impurity F 3-amino-2-hydroxybenzoic acid (3-aminosalicylic acid)
O OH
NH2
OHO
ONH2
747. Mesalazine EP Impurity G 2,5-dihydroxybenzoic acid O
HO
OH
HO
748. Mesalazine EP Impurity H 2-hydroxybenzoic acid
(salicylic acid) O
HO
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
749. Mesalazine EP Impurity L 2-chlorobenzoic acid O
HO
Cl
750. Mesalazine EP Impurity J 3,5-diamino-2-hydroxybenzoic
acid (diaminosalicylicacid)
O
HO
HO
NH2
NH2
751. Mesalazine N-acetyl impurity
N-acetyl impurity
752. Mesalazine EP Impurity K aniline H2N
753. Metamizole EP Impurity A N-(2,5-dihydro-2,3-dimethyl-5-oxo-1-phenyl-1H-pyrazol-4-
yl)formamide
O HN
NN
O
754. Metamizole EP Impurity B 4-amino-1,2-dihydro-2,3-
dimethyl-1-phenylpyrazol-5-one
NN
OH2N
755. Metamizole EP Impurity C 1,2-dihydro-2,3-dimethyl-4-
(methylamino)-1-phenylpyrazol-5-one
NN
OHN
756. Metamizole EP Impurity D 4-(dimethylamino)-1,2-dihydro-2,3-dimethyl-1-
phenylpyrazol-5-one N
N
O
N
757. Metformin EP Impurity A Cyanoguanidine NH
NH2
NHN
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
758. Metformin EP Impurity C N,N-dimethyl-1,3,5-triazine-
2,4,6-triamine N
N
NN
NH2
NH2
759. Metformin EP Impurity D 1,3,5-triazine-2,4,6-triamine N
N
NH2N
NH2
NH2
760. Metformin EP Impurity E 1-methylbiguanide
NH
NH
HN
NH
H2N
761. Metformin EP Impurity F N-methylmethanamine HN
762. Metformin Hydrochloride
Metformin Related
Compound A 1-Cyanoguanidine
NH
NH2
NHN
763. Methotrexate Methotrexate
Related Compound B
(S)-2-{4-[2,4-diaminopteridin-6yl)methylamino]benzoamido
}pentanedioic acid
764. Metoprolol EP Impurity C 4-[(2RS)-2-hydroxy-3-[(1-
methylethyl)amino]propoxy]benzaldehyde
O
O NH
OH
765. Metoprolol EP Impurity A (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propa
n-2-ol
HO
O
O
HN
766. Metoprolol EP Impurity O
1,1’-[(1-methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]propa
n-2-ol] N
OH
O
O
OH
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
767. Metoprolol EP Impurity B 4-(2-methoxyethyl)phenol
O
OH
768. Metoprolol EP Impurity G 2-(4-hydroxyphenyl)ethanol OH
HO
769. Metoprolol EP Impurity D (2RS)-3-[4-(2-
methoxyethyl)phenoxy]propane-1,2-diol
HO
OHO
O
770. Milnacipran Milnacipran
Impurity
2-[(1,3-Dioxo-2,3-dihydro-1H-isoindol-2-yl)methyl]N,N-
diethyl-1-phenylcycloprapane-1-carboxamide
O
N
N
O
O
771. Molsidomine EP Impurity B 4-nitrosomorpholine N ON
O
772. Molsidomine EP Impurity D morpholine-4-carbaldehyde N O
O
773. Molsidomine EP Impurity E morpholine HN
O
774. Montelukast Ep Impurity F
2-(1-((((S)-3-(2-acetylphenyl)-1-(3-((E)-2-(7-chloroquinolin-
2-yl)vinyl)phenyl)propyl)sulfanyl
)methyl)cyclopropyl)acetic acid
O
HO
S (S)
O
N
Cl
(E)
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
775. Montelukast EP Impurity C
2-(1-(((S)-1-(3-((E)-2-(7-chloroquinolin-2-
yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-
yl)phenyl)propylsulfinyl)methyl)cyclopropyl) acetic
acid(Montelukast Sulfoxide impurity)
O
HO
S
O OH
N
Cl
776. Montelukast EP Impurity B
2-(1-(((S)-1-(3-((E)-2-(7-chloroquinolin-2-
yl)vinyl)phenyl)-3-(2-(prop-1-en-2-
yl)phenyl)propylthio)methyl)cyclopropyl)acetic
acid(Montelukast Styrene impurity)
O
HO
S N
Cl
777. Montelukast EP Impurity
1-[[[(IR)-1-[3-[(IE)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-
3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thi
o]methyl]cyclopropane acetamide (Montelukast
amide impurity)
O
H2N
S (R)
OH
N
Cl
(E)
778. Montelukast EP Impurity
2-(1-((((R) -1-(3-(2-(7-Chloroquinolin-2-
yl)ethyl)phenyl)-3-(2-(2-hydroxypropan-2-
yl)phenyl)propyl)Sulfonyl)methyl)cyclopropyl)acetic acid
OHO
S
O
O
HO
N
Cl
779. Montelukast EP Impurity
2-[2-[3(S)-[3-[2-(7-Chloro-2-quinolinyl)-ethynyl][phenyl]-3-
hydroxypropyl]phenyl]-2-propanol
HO (S)
OH
N
Cl
(E)
780. Moxifloxacin Methylester impurity(IH)
methyl 1-cyclopropyl-6-fluoro-1,4-dihydro-7-((4aS,7aS)-
octahydropyrrolo[3,4-b]pyridin-6-yl)-8-methoxy-4-oxoquinoline-3-carboxylate
N
O
O
O
O
HN
N
F
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
781. Moxifloxacin Ethylester
impurity(IH)
ethyl 1-cyclopropyl-6-fluoro-1,4-dihydro-7-((4aS,7aS)-
octahydropyrrolo[3,4-b]pyridin-6-yl)-8-methoxy-4-oxoquinoline-3-carboxylate
N
O
O
O
O
HN
N
F
H
H
782. Moxifloxacin EP Impurity A
1-cyclopropyl-6,8-difluoro-7-[(4aS,7aS)-octahydro-6H-
pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-
carboxylic acid
N
O
HO
O
HN
N
F
F
H
H
783. Moxifloxacin EP Impurity C
1-cyclopropyl-8-ethoxy-6-fluoro-7-[(4aS,7aS)-octahydro-
6H-pyrrolo[3, 4-b]pyridin-6-yl]-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid
N O
OH
O
HN
N
F
O
H
H
784. Moxifloxacin EP Impurity B
1-cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-
pyrrolo[3,4-b] pyridin-6-yl]-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid
N
O
HO
O
HN
N
O
O
H
H
785. Moxifloxacin Methoxy Quinoline Impurity
1-cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-
oxoquinoline-3-carboxylic acid
N
O
OH
O
O
F
F
786. Moxifloxacin Methoxy
Quinoline Ester Impurity
ethyl 1-cyclopropyl-6,7-difluoro-1,4-dihydro-8-
methoxy-4-oxoquinoline-3-carboxylate
N
O
O
O
O
F
F
787. Moxifloxacin EP Impurity E
1-cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,7aS)-
octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-
dihydroquinoline-3-carboxylic acid
N
O
HO
O
HN
N
OH
F
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
788. Moxifloxacin N-methyl
impurity(IH)
1-cyclopropyl-6-fluoro-1,4-dihydro-7-((4aS,7aS)-
octahydro-1-methylpyrrolo[3,4-b]pyridin-6-yl)-8-methoxy-4-oxoquinoline-
3-carboxylic acid
N O
OH
O
ON
N
FH
H
789. Mycophenolate EP Impurity E
methyl (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-
methylhex-4-enoate
O
O
O
O
O
OH
790. Mycophenolate EP Impurity G
2-(morpholin-4-yl)ethyl (4E)-6-(4-hydroxy-6-methoxy-7-
methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate N-oxide
CH•
O
OO
O
O
OH
N+OO-
791. Mycophenolate EP Impurity F
(4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo1,3-
dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid
(mycophenolic acid),
O
HO
O
O
O
OH
792. Nabumetone EP Impurity C 4-(2-methoxynaphthalen-6-
yl)butan-2-ol HO
O
793. Naproxen EP Impurity K (1RS)-1-(6-
methoxynaphthalen-2-yl)ethanol O
HO
794. Naproxen EP Impurity N 2-bromo-6-
methoxynaphthalene O
Br
795. Naproxen EP Impurity L 1-(6-methoxynaphthalen-2-
yl)ethanone O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
796. Naratriptan Hydrochloride
NARATRIPTAN Related
Compound A
3-(1-Methylpiperidin-4-yl)-1H-Indole
HNN
797. NARATRIPTAN HYDROCHLORIDE
NARATRIPTAN Related
Compound B
2-[3-(1-Methyl-1,2,3,6-tetrahydroppyridine-4-yl)1H-indole-5yl]-ethane sulfonic
acid methylamide NH
N
S
O
ONH
798. Nateglinide Nateglinide
Related Compound A
(trans-4-isopropylcyclohexanecarboxyli
c acid) O
OH
799. Nateglinide Nateglinide
Related Compound B
N-(trans-4-isopropylcyclohexanecarbonyl
)-L-phenylalanine
HN
O
OH
O
800. Nateglinide Nateglinide
Related Compound C
N-(cis-4-isopropylcyclohexylcarbonyl)-
D-Phenylalanene
HN
O
OH
O
801. Nateglinide Nateglinide
Ethyl analogue
N-(trans-4-Ethylcyclohexylcarbonyl)-D-
phenylalanine
HN
O
HOO
802. Nateglinide Nateglinide Ethyl ester impurity
N-(trans-4-isopropylcyclohexylcarbonyl)-D-phenylalanine-ethyl ester
HN
O
O
O
803. Nateglinide Nateglinide IPP
impurity
N-(trans-4-Isopropylcyclohexylcarbonyl)-
D-phenylalanine-D-phenylalanine
HN
O
OH
NH2
O
HO
O
804. Nebivolol Hydrochloride
NEBIVOLOL Related
Compound A
[2S*[IR*,5R*(S*)]]-alfa,alfa’-[Iminobis(methylene)]bis[6-
fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol]
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
805. NEBIVOLOL HYDROCHLORIDE
NEBIVOLOL Related
Compound B
[2S*[IR*,5S*(S*)]]-alfa,alfa’-[Iminobis(methylene)]bis[6-
fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol
806. Nevirapine Nevirapine
Impurity
N-(2-Chloro-4-methyl-3-pyridyl)-2-(cyclopropylamino)-
3-pyridinecarboxamide
N
OHN
HN
N
Cl
807. Nevirapine Nevirapine
Related Compound A
[5,11-Dihydro-6H-11-ethyl-4-methyl-dipyrido[3,2-b;2',3'-
e][1,4]diazepin-6-one]
NH
NN
N
O
808. Nevirapine Nevirapine
Impurity
2-((2'-Cyclopropylamino)-3'-pyridyl)-7-methyloxazolo[5,4-
B]-pyridine NO
NN
NH
809. Nevirapine Nevirapine
Related Compound B
5,11-Dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-
e][1,4]diazepin-6-one
NH
NH N
N
O
810. Nevirapine Nevirapine
Impurity
11-Propyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b;2'3'-
e][1,4]diazepin-6-one(N-propyl Nevirapine)
NH
N NN
O
811. Nelfinavir Mesylate NELFINAVIR
Impurity 3-Hydroxy-2-methyl benzoic
acid O
HO
OH
812. NELFINAVIR MESYLATE
NELFINAVIR Impurity
3-Acetyloxy-2-methyl benzoic acid
O
OHO
O
813. NELFINAVIR MESYLATE
NELFINAVIR Impurity
(3S,4AS,8AS)-N-(1,1-Dimethylethyl)decahydro-2-
[(2R,3R)-2-hydroxy-3-amino-4-(phenylthio)butyl]-3-
isoquinolinecarboxamide
N
O
NH
SH2N
OH
H H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
814. Nifedipine EP Impurity A
dimethyl 2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-
dicarboxylate (nitrophenylpyridine
analogue)
N
O O
O
O
N+
O
O-
815. Nilotinib NILOTINIB Impurity
3-(4-methyl-1H-Imidazole-1-yl)-5-
(trifluoromethyl)benzenamine NH2
F
F
F
N
N
816. NILOTINIB NILOTINIB Impurity
4-methyl-3-(4-(pyridine-3-yl)pyrimidin-2-yl
amino)benzoic acid
O
HO
HN N
N
N
817. Nimesulide EP Impurity C 2-phenoxyaniline,
NH2
O
818. Nimesulide EP Impurity D 4-nitro-2-phenoxyaniline
NH2
O
N+
O
-O
819. Nimesulide EP Impurity A N-(2,4-dinitro-6-
phenoxyphenyl)methanesulphonamide
SO
O
NH
O
N+O
-O
N+ O-O
820. Nimesulide EP Impurity B N-(2-
phenoxyphenyl)methanesulphonamide,
S
O
O
HNO
821. Nimesulide EP Impurity E N,N-bis(methylsulphonyl)-2-
phenoxyaniline, NO S
O
O
SO
O
822. Nimesulide EP Impurity F N,N-bis(methylsulphonyl)-4-
nitro-2-phenoxyaniline N
O
N+
O
O-
S
O
O
SO O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
823. Nitazoxanide Nitazoxanide
Related Compound A
2-Amino-5-nitrothiazole S
NN+
O
-O
NH2
824. Ondansetron Ondansetron
Related Compound C
1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one
N
O
825. Olanzapine Olanzapine
Amine impurity
4-Amino-2-methyl-10H-thieno-[2,3-
b][1,5]benzodiazapine NH
N
S
NH2
826. OLANZAPINE Olanzapine N-
Desmethyl Impurity
2-Methyl-4-(1-piperazinyl)-10H-thieno-[2,3-
b][1,5]benzodiazepine NH
N
S
N
NH
827. OLANZAPINE Olanzapine
Related Compound B
2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-on HN
HN S
O
828. OLANZAPINE Olanzapine N-ethyl impurity
2-Methyl-4-[4-ethyl-1-piperazinyl)-10H-thieno[2,3-
b][1,5]benzodiazepine NH
N
S
N
N
829. OLANZAPINE EP Impurity A 2-(2-Nitroaniline)-5-methyl-
thiophene-3-carbonitrile
S
N
HN
N+O
-O
830. OLANZAPINE Olanzapine
Impurity 2-Amino-5-methyl-thiophene-
3-carbonitrile.
S
N
NH2
831. Olmesartan EP Impurity A
4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H-1,2,3,4-
tetrazol-5-yl)phenyl]phenyl}methyl)-1H-
imidazole-5-carboxylic acid N
N
O
HO
N
HNN
N
OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
832. Olmesartan EP Impurity C
(5-methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-
propen-2-yl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-
yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate
N
N
O
O
N
HNN
N
O
OO
833. Olmesartan Olmesartan
Trityl Impurity
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl4-(2-hydroxypropan-
2-yl)-2-propyl-1-[[2'-(1-triphenylmethyl-1H-tetrazole-5-yl)biphenyl-4-yl]methyl]-1H-
imidazole-5-carboxylate
N
N
O
O-N
N N
N
HO
O
O
O
834. Olmesartan Olmesartan
Impurity
4-[1-Hydroxy-1-methylethyl]-2-propyl-1-[[2'-1H-tetrazole-5-yl]1,1'-biphenyl-4-yl-methyl]-
1H-Imidazole-5-carboxlylic acid
N
N
OHO
NH
NN
N HO
835. Omeprazole EP Impurity A 5-methoxy-1H-benzimidazole-
2-thiol N
HN
HS
O
836. Omeprazole EP Impurity C
5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-
yl)methyl]sulphanyl]-1H-benzimidazole (ufiprazole)
N
HN
S
N
O O
837. Omeprazole EP Impurity D
5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-
yl)methyl]sulphonyl]-1H-benzimidazole (omeprazole
sulphone),
N
NH
S
O
O N
O
O
838. Omeprazole EP Impurity E
5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]sulfinyl]-1H-benzimidazole 1'-oxide
N
NH
S
O
N+
O
O
-O
839. Omeprazole EP Impurity I
4-methoxy-2-[[(5-methoxy-1H-benzimidazol-2-
yl)sulphonyl]methyl]-3,5- dimethylpyridine 1-oxide
N+
S
O
O
N
HN
O
O-O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
840. Ondansetron EP Impurity C 9-methyl-1,2,3,9-tetrahydro-
4H-carbazol-4-one
N
O
841. Ondansetron EP Impurity D 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-
carbazol-4-one
N
O
842. Ondansetron EP Impurity F 2-methyl-1H-imidazole
N
NH
843. Orlistat Orlistat Related
Compound C Triphenylphosphine oxide P O
844. Oseltamivir OSELTAMIVIR
Related Compound A
(3R,4R,5S) Methyl4-Acetamido-5-amino-3-
(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate O
OO
NH2
O
HN
845. OSELTAMIVIR OSELTAMIVIR
Related Compound B
4-acetylamino-3-hydroxy benzoic acid ethyl ester
O
O
OH
NH
O
846. OSELTAMIVIR OSELTAMIVIR
Impurity Triphenyl phosphine oxide P O
847. OSELTAMIVIR Oseltamivir
Carboxylic Acid
(3R,4R,5S)-4-(Acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylicacid O
OHO
NH2HN
O
848. OSELTAMIVIR OSELTAMIVIR
Impurity
Ethyl(3R,4R,5S)-4-(Acetylamino)-5-azido-3-
(ethylpropoxy)-1-cyclohexene-1-carboxylate O
OO
NN+N-
HNO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
849. Oxaliplatin Oxaliplatin
Related Compound A
oxalic acid dihydrate O
OH
O
HO
H
OH
H O
H
850. Oxybuprocaine Hydrochloride
EP Impurity A 4-aminobenzoic acid O
HO
NH2
851. Oxybutynin Chloride
Oxybutynin Chloride
852. Oxybutynin Chloride
Oxybutynin Related
Compound A Phenylcyclohexylglycolic Acid
HO
OHO
853. Paclitaxel Paclitaxel Related
Compound A Cephalomannine
854. Paclitaxel Paclitaxel Impurity
(2ar,4s,4as,6R,9S,11S,12S,12ar,12bs)-12b-(Acetyloxy)-12-
(benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12,12a,1
2b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-
tetramethyl-7,11-methano-5H-cyclodeca(3,4)benz(1,2-
b)oxet-5-one
855. Paclitaxel Paclitaxel Impurity
6,12b-Bis(acetyloxy)12(benzoyloxy)-1,2a3,4,4a,6,9,10,11,12,12a,1
2b-dodecahydro-4,9,11-trihydroxy-4a,8,13,13-
tetramehtyl(2ar,4S,4as,6R,9S,11S,12S,12ar,12bs)-rel-7,11-
methano-5H-cyclodeca[3,4]benz[1,2-
b]oxet-5-one
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
856. Paclitaxel Paclitaxel Impurity
(2α,4 α,5β,7β,10 β,13 α)-4-(Acetyloxy)-13{[(2R,3S)-3-
(benzoylamino)-2-hydroxy-3-phenylpropanoyl]oxy}-
1,7,10trihydroxy-9-oxo-5,20-epoxytax-11-en-2-ylbenzoate
857. Paclitaxel Paclitaxel Impurity
(2α,4β,5β,7α,10β,13α)-4,10-Bis(acetyloxy)-13-{[(2R,3S)-3-(benzoylamino)-2-hydroxy-3-
phenylpropanoyl]oxy}-1,7-dihydroxy-9-oxo-5,20-
epoxytax-11-en-2-ylbenzoate
858. Paclitaxel Paclitaxel Impurity
(2as,4s,4as,6R,9S,11S,12S,12ar,12bs)-6-12b-Bis(acetyloxy)-
12-(benzyloxy) 2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-11-hydroxy-4a,8,13,13-tetramethyl-5-oxo-
4-[[(2,2-dichloroethoxy)carbonyl]oxy]-
7,11-methano-1H-cyclodeca[3,4]benz[1,2b]oxet-
9-ylester,(ar,βs)-β-(benzoylamino)-α-hydroxy-
benzenepropanoic acid
859. Pantoprazole EP Impurity A
5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulphonyl]-
1Hbenzimidazole
N
NH
S
O
ON
O
O
O
F
F
860. Pantoprazole EP Impurity B
5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulphanyl]-
1Hbenzimidazole N
HN
S
N
O O O
F
F
861. Pantoprazole EP Impurity C 5-(difluoromethoxy)-1H-
benzimidazole-2-thiol N
HN
HS
O
F
F
862. Pantoprazole EP Impurity
D&F Mixture EP Impurity D&F Mixture
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
863. Pantoprazole EP Impurity N-Oxide Impurity
EP Impurity N-Oxide Impurity N
NH
S
ON
O
O
O
F
FO
864. Pantoprazole EP Impurity Sulfone N-
Oxide impurity
EP Impurity Sulfone N-Oxide impurity
N
NH
S
ON
O
O
O
F
FO
O
865. Pantoprazole Pantoprazole
Related Compound C
5-(difluoromethoxy)-1H-benzimidazole-2-thiol
N
HN
HS
O
F
F
866. Paracetamol EP Impurity D N-phenylacetamide O
NH
867. Paracetamol EP Impurity F 4-nitrophenol N+O
-O
OH
868. Paracetamol EP Impurity K 4-aminophenol NH2HO
869. Paracetamol EP Impurity F 4-nitrophenol N+O
-O
OH
870. Paracetamol EP Impurity J N-(4-chlorophenyl)acetamide O
NH
Cl
871. Prasugrel PRASUGREL
Impurity
5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-
5,6.7a-tetrahydrothieno[3,2-c]pyridine-2(4H)-one
N
S
O
H
O
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
872. PRASUGREL PRASUGREL
Impurity
5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-3-
vinyl-4,5,6.7a-tetrahydrothieno[3,2-c]pyridine-2-yl acetate
O
ON
S
O
F
873. Pazopanib Pazopanib Impurity
5-amino-2-methyl benzene sulphonamide S
O
O
NH2
H2N
874. Pazopanib Pazopanib Impurity
N-(2-Chloropyrimidin-4-yl)N-2,3-trimethyl-2H-indazol-6-
amine
NN
NN
N
Cl
875. Pemetrexed PEMETREXED
Disodium
N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-
d]pyrimidin-5-yl)ethyl]benzoyl]-D-
glutamiaciddisodium O
NaO
OONa
NH
ONH
N
NH
O NH2
876. PEMETREXED Pemetrexed Impurity A
N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-
d]pyrimidin-5-yl)ethyl]benzoicacid
HO
ONH
N
NH
O NH2
877. PEMETREXED Pemetrexed
Impurity
N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-
d]pyrimidin-5-yl)ethyl)benzoyl]-L-glutamic acid dimetyl ester 4-toluene
sulphonic acid salt
NH
OO
O
O
O
NH
N
NH
O
O NH2
878. Perindopril EP Impurity A (2S,3aS,7aS)-octahydro-1H-
indole-2-carboxylic acid
HN O
OHH
H
879. Perindopril EP Impurity B
(2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-carboxybutyl]amino]propanoy
l]octahydro-1Hindole-2-carboxylic acid
N
O
HO
O
HN
O
OH
H
H
880. Perindopril EP Impurity E
(2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-[(1methylethoxy)carbonyl]but
yl]amino] propanoyl]octahydro-1H-indole-2-carboxylic acid
N
O
HO
O
HN O
O
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
881. Perindopril EP Impurity B
(2S,3aS,7aS)-1-[(2S)-2[[(1S)1carboxybutyl]amino]propanoyl]octahydro-1Hindole-
2-carboxylic acid
N
O
HO
O
HN
OOH
H
H
882. Phenylephrine EP Impurity A (1R)-2-amino-1-(3-
hydroxyphenyl)ethanol (norphenylephrine)
OH
NH2
HO
883. Phenylephrine EP Impurity C 1-(3-hydroxyphenyl)-2-
(methylamino)ethanone (phenylephrone)
NH
HO
O
884. Phenylephrine EP Impurity D (1R)-2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanol
(benzylphenylephrine) HO N
OH
885. Phenylephrine EP Impurity E 2-(benzylmethylamino)-1-(3-
hydroxyphenyl)ethanone (benzylphenylephrone)
HO N
O
886. Phenytoin EP Impurity A diphenylmethanone
(benzophenone), O
887. Phenytoin EP Impurity B diphenylethanedione (benzil).
O
O
888. Phenytoin Phenytoin
Related Compound A
2,2-Diphenylglycine H2N
OHO
889. Pioglitazone EP Impurity C
5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)-3-(2-(5-
ethylpyridin-2-yl)ethyl)thiazolidine-2,4-dione
SN
O
O
N
O N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
890. Pioglitazone EP Impurity B 5-{4-[2-(5-Ethyl-2-pyridinyl)
ethoxy]benzylidene}-2,4-thiazolidinedione
S
HN
O
O O N
891. Pioglitazone Pioglitazone
Imino Impurity
5-(4-(2-(5-ethylpyridin-2-yl)ethoxy)benzyl)-4-
iminothiazolidin-2-one
SNH
O
NH
ON
892. Pioglitazone Pioglitazone
Impurity
5-{4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl}-4-[4-[2-
(5-ethyl-2-pyridyl)ethoxy]phenoxy]-2,5-
dihydro-1,3-thiazole-2-one
S
NO
O
O
NO
N
893. Piracetam EP Impurity A pyrrolidin-2-one (2-
pyrrolidone) NH
O
894. Pirenzepine Hydrochloride
EP Impurity D 1-methylpiperazine N NH
895. Piroxicam EP Impurity A pyridin-2-amine N
H2N
896. Piroxicam EP Impurity B 4-hydroxy-N-(pyridin-2-yl)-2H-
1,2-benzothiazine-3-carboxamide 1,1-dioxide
SHNO
NH
N
HO
OO
897. Piroxicam EP Impurity C 4-hydroxy-2-methyl-2H-1,2-
benzothiazine-3-carboxamide 1,1-dioxide
SN
O
NH2
OH
O
O
898. Piroxicam EP Impurity D methyl (1,1-dioxido-3-oxo-1,2-
benzisothiazol-2(3H)-yl)acetate
O
O
SN
O
O--O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
899. Piroxicam EP Impurity E ethyl (1,1-dioxido-3-oxo-1,2-
benzisothiazol-2(3H)-yl)acetate
O
O SN
O
O--O
900. Piroxicam EP Impurity F 1-methylethyl (1,1-dioxido-3-oxo-1,2-benzisothiazol-2(3H)-
yl)acetate
O
O SN
O
O--O
901. Piroxicam EP Impurity G methyl 4-hydroxy-2H-1,2-
benzothiazine-3-carboxylate 1,1-dioxide
S
HN
O
O
HO
O
O
902. Piroxicam EP Impurity H ethyl 4-hydroxy-2H-1,2-
benzothiazine-3-carboxylate 1,1-dioxide
SHNO
O
HO
OO
903. Piroxicam EPImpurity I
1-methylethyl 4-hydroxy-2H-1,2-benzothiazine-3-
carboxylate 1,1- dioxide
SHNO
O
HO
OO
904. Piroxicam EPImpurity J
methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-
carboxylate 1,1- dioxide
SN
O
O
OH
O
O
905. Piroxicam EPImpurity K
ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-
carboxylate 1,1- dioxide
SNO
O
HO
OO
906. Piroxicam EPImpurity L
1-methylethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-
3- carboxylate 1,1-dioxide
SNO
O
HO
OO
907. Pitavastatin PITAVASTATIN
(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-
3,5-dihydroxyhept-6-enoic acid
O
HO
OHOH
N
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
908. PITAVASTATIN PITAVASTATIN
Lactone
(4R,6S)-6-((E)-2-(2-cyclopropyl-4-(4-
fluorophenyl)quinolin-3-yl)vinyl)-4-hydroxytetrahydro-
2H-pyran-2-one
OO
OH
N
F
909. PITAVASTATIN PITAVASTATIN Tert-butyl ester
(E,3R,5S)-tert-butyl 7-(2-cyclopropyl-4-(4-
fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
O
O
OHOH
N
F
910. Povidone EP Impurity B pyrrolidin-2-one (2-
pyrrolidone). NH
O
911. Pramipexole
Pramipexole Related
Compound A (EP-A)
(S)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole
S
N
NH2
H2N
912. Pramipexole EP Impurity B (S)-2-Amino-6-propionamido
tetrahydro benzothiazole S
N O
HN
H2N
913. Pramipexole Pramipexole impurity C
(R)-4,5,6,7-tetrahydro-N6-propyl-2,6-
benzothiazolediamine((R)-Pramipexole)
S
N
NH
H2N
914. Pregabalin Pregabalin 4-
eliminate impurity
4-Eliminate impurity
915. Prilocaine EP Impurity B 2-methylbenzenamine (o-
toluidine), H2N
916. Prilocaine Hydrochloride
Prilocaine Hydrochloride
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
917. Prilocaine Hydrochloride
Prilocaine Related
Compound A o-toluidine hydrochloride H2N
HCl
918. Primidone Primidone
919. Primidone Primidone
Related Compound C
2-phenyl butyramide
O
NH2
920. Probucol Probucol
921. Probucol Probucol Related
Compound A
2,2',6,6'-tetra-tert-butyldiphenoquinone
922. Proguanil Hydrochloride
EP Impurity A 1-Cyano-3-(1-
methylethyl)guanidine NH
NH
NHN
923. Proguanil Hydrochloride
EP Impurity B 4-chloroaniline H2N Cl
924. Propacetamol Hydrochloride
EP Impurity A paracetamol O
NH
OH
925. Propacetamol Hydrochloride
EP Impurity B 4-aminophenol NH2HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
926. Propafenone EP Impurity E 1-[2-[(2RS)-3-chloro-2-
hydroxypropoxy]phenyl]-3-phenylpropan-1-one
OO
HOCl
927. Propafenone EP Impurity C 1-[2-[[(2RS)-
oxiranyl]methoxy]phenyl]-3-phenylpropan-1-one O
O
O
928. Propafenone EP Impurity A 1-(2-hydroxyphenyl)-3-
phenylpropan-1-one
O OH
929. Propafenone EP Impurity D 1-[2-[(2RS)-2,3-
dihydroxypropoxy]phenyl]-3-phenylpropan-1-one O
O
OHHO
930. Propanolamine Propanolamine 3-aminopropan-1-ol HO NH2
931. Propanolol EP Impurity A (2RS)-3-(naphthalen-1-yloxy)propane-1,2-diol
OH
HOO
932. Propanolol EP Impurity C 1,3-bis(naphthalen-1-
yloxy)propan-2-ol OH
O
O
933. Propyl Hydroxybenzoate
EP Impurity A 4-hydroxybenzoic acid O
HO
OH
934. Prulifloxacin PRULIFLOXACIN
Impurity
6-Fluoro-1-methyl-4-oxo-7-(1-piperazinyl)-4H-
[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid(Ulifloxacin)
N
S
O
HO
N NH
OF
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
935. Pyridoxine Hydrochloride
EP Impurity A 6-methyl-1,3-dihydrofuro[3,4-
c]pyridin-7-ol N
OOH
936. Pyridoxine Hydrochloride
EP Impurity B 5-(hydroxymethyl)-2,4-
dimethylpyridin-3-ol N
HO
OH
937. Pyrrolidone
Pyrrolidin-2-one NH
O
938. Pyrrolidone EP Impurity A butane-1,4-diol HOOH
939. Pyrrolidone EP Impurity C 1-methylpyrrolidin-2-one (N-
methylpyrrolidone) N
O
940. Quetiapine Quetiapine Impurity A
11-(1-piperazinyl)dibenzo-(1,4)-thiazepine
HN
N
S
N
941. Quetiapine Quetiapine Metabolite
Dibenzo-(1,4)-thiazepine-11(10H)-one
NH
S
O
942. Quetiapine Quetiapine
Hydroxy Impurity
2-(4-Dibenzo[b,f]-[1,4]-thiazepine-11-yl-1-piperzinyl)ethanol
hemifumarate
OH
N
N
S
N
943. Rabeprazole Rabeprazole
Related Compound C
1H-benzimidazole-2-thiol N
HN
HS
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
944. Rabeprazole Rabeprazole
Related Compound E
2-[[[4-(3-Methoxypropoxy)-3-methyl-2-
pyridinyl]mehtyl]thio]-1H-benzimidazole (Rabeprazole
Sulfide impurity)
NH
NS
N
O
O
945. Rabeprazole EP Impurity B Rabeprazole Sulfone n-oxide
impurity
NH
NS
ON
O
O
O
O
946. Rabeprazole EP Impurity A Rabeprazole N-Oxide impurity NH
NS
ON
O
O
O
947. Rabeprazole EP Impurity D
2-((4-(3-methoxypropoxy)-3-methylpyridin-2-
yl)methylsulfonyl)-1H-benzo[d]imidazole
NH
NS
ON
O
O
O
948. Racecadotril EP Impurity E 2-benzylprop-2-enoic acid (2-
benzylacrylic acid) O
OH
949. Raltegravir RALTEGRAVIR
Impurity
N-(4-Fluorobenzyl)-2-(2-aminopropan-2-yl)-1,6-
dihydro-5-hydroxy-1-methyl-6-oxopyrimidine-4-
carboxamide
NN
O
HN
O
OH
H2N
F
950. RALTEGRAVIR RALTEGRAVIR
Des-Fuoro Impurity
5-Hydroxy-1-methyl-2-(1-methyl-1-[(5-
methyl[1,3,4]oxadiazol-2-carbonyl)-amino]-ethyl)-6-
oxo-1,6-dihydro pyrimidine-4-carbxylicacid benzylamide
N
N
O
NH
O
HN
O
O
N N
HO
951. RALTEGRAVIR RALTEGRAVIR
Impurity
N1-[1-(4-[(4-Fluorobenzyl)amino]carbonyl-5-hydroxy-1mehyl-6-oxo-1.6-
dihydro-2-pyrimidinyl)-1-methylethyl]ethanediamide
O
HN
O
H2N
N
N
OHO
O
NH
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
952. Ramipril EP Impurity A
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-(methoxycarbonyl)-3-
phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrro
le-2-carboxylic acid (ramipril methyl ester)
NO
HO
O HN
OO
H
H
953. Ramipril EP Impurity B
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-[(1-methylethoxy)carbonyl]-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrro
le-2-carboxylic acid (ramiprilisopropyl ester)
N
O
HOO
HN
OO
H
H
954. Ramipril EP Impurity C
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)-propyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-
carboxylic acid (hexahydroramipril)
N
O
OH
O
NH
OO
H
H
955. Ramipril EP Impurity D
ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro-
2H-cyclopenta[4,5]pyrrolo[1,2-
a]pyrazin-2-yl]-4-phenylbutanoate (ramipril
diketopiperazine)
O
O
NN
O
O
H
HH
956. Ramipril EP Impurity E
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-carboxy-
3phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril
diacid)
N
O
OH
O
NH
OOH
H
H
957. Ramipril EP Impurity G methylbenzene
958. Ramipril Ramipril Impurity
Benzyl(cis,endo)-octahydrocyclopenta[b]pyrrol
e-2(S)-carboxylate hydrochloride
N
O
O-
H
Cl
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
959. Ramipril Ramipril Impurity
N-[1(S)-Carboethoxy-3-phenylpropyl]-(S)-alanine N
HO
OH
OO
960. Ranitidine Hydrochloride
EP Impurity H N-methyl-2-nitroacetamide O
NH
N+ O-O
961. Ranitidine Hydrochloride
EP Impurity K N-methyl-1-methylthio-2-
nitroethenamine HN
N+ O
-O
S
962. Ranitidine Hydrochloride
EP Impurity B
2-[[[5-[(dimethylamino)methyl]furan
-2-yl]methyl]sulphanyl]ethanami
ne
NH2S
O
N
963. Ranitidine Hydrochloride
EP Impurity C
N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphinyl]ethyl]-
N¢-methyl-2- nitroethene-1,1-diamine
964. Ranitidine Hydrochloride
Ranitidine Related
Compound B
N,N'-bis[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-2-
nitro-1,1-ethenediamine NH
NH
N+
O
-OS
O
N
S
O
N
965. Rasagiline HYDRCHLORIDE
Rasagiline Impurity
(R)-2,3-Dihydro-1H-inden-1-amine hydrochloride((R)-1-
Aminoindane) H2NH
Cl
966. Rasagiline HYDRCHLORIDE
Rasagiline Impurity
(1S)-2,3-Dihydro-N-2-propyn-1-yl-1H-inden-1-amine((S)-
Rasagiline) (S)N
H
967. Repaglinide REPAGLINIDE
Related Compound A
(S)-3-Methyl-1-[2-(1-piperidinyl)phenyl]butylamine,N-acetyl-L-glutamate salt (EP-
C)
NH2 N
NH
O
HO
O-OO
.
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
968. REPAGLINIDE REPAGLINIDE
Related Compound B
(3-ethoxy-4-ethoxycarbonyl-phenyl acetic acid) (EP-B) O
O
O
O
O
969. REPAGLINIDE EP Impurity A 4-(carboxymethyl)-2-ethyxybenzoic acid
O
HO
O
O
HO
970. REPAGLINIDE EP Impurity D
Ethyl2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amono-2-
oxoethyl]benzoate
971. Rilpivirine Hydrochloride
RILPIVIRINE Impurity
4-(4-Hydroxypyrimidin-2-ylamino)benzonitrile
N NH
N
N OH
972. RILPIVIRINE HYDROCHLORIDE
RILPIVIRINE Impurity
(2E)-3-(4-Amino-3,5-dimethylphenyl) acrylonitrile
N
H2N
973. RILPIVIRINE HYDROCHLORIDE
RILPIVIRINE Impurity
4-[(4-Chloro-2-pyrimidinyl)amino]benzonitril
e
N
NH
N
N
Cl
974. RILPIVIRINE HYDROCHLORIDE
RILPIVIRINE Z-ISOMER
4-{[4-({4-[(Z)-2-cyanovinyl]-2,6-
dimethylphenyl}amino)pyrimidin-2-
yl]amino}benzonitrile(RILPIVIRINE- Z-ISOMER)
NHN
N
NHN
N
975. Riluzole Riluzole Related
Compound A 4-trifluoromethoxyaniline
H2N
OF
FF
976. Riluzole Riluzole Impurity
Thiourea[4-Triflouromethoxyphenyl]
S
N
HN
OF
FFH2N
S
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
977. Riluzole Riluzole Impurity
4-Bromo-6-(trifluoromethoxy)-2-
benzothiazolamine S
NNH2
O
F
F
F
Br
978. Rimonabant RIMONABANT
Impurity
5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-pyrazole-3-carboxylic acid N
NO
HO
ClCl
Cl
979. RIMONABANT RIMONABANT
Impurity
5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-pyrazole-3-carboxamide N
NO
H2N
ClCl
Cl
980. RIMONABANT RIMONABANT
Des Chloro Impurity
N-Piperidino-1-(2,4-dichlorophenyl)-5-phenyl-4-
methyl-pyrazole-3-carboxamide(Des chloro
impurity)
NN
O
NH
ClCl
N
981. RIMONABANT RIMONABANT
Impurity
N-Piperidino-5-(3-chlorophenyl)-1-(2,4-
dichlorophenyl)-4-mehtyl-pyrazole-3-carboxamide (3-
Chloro Rimonabant impurity)
NN
O
NH
ClCl
Cl
N
982. RIMONABANT RIMONABANT
Impurity
5-(4-Chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-
pyrazole-3-carbronylpiperidine
N
O
NN
ClCl
Cl
983. Ritonavir RITONAVIR
Impurity
gama-(S)-Amino alpha- (1S)-(thiazoly methyloxycarbonyl)-
amino-(2-phenylethyl)- (S)-benzene butanol
984. RITONAVIR EP Impurity A
N-[[(methyl[[2-(1-methylethyl)-4-
thiazoyl]methyl]amino]carbonyl]-L-valine
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
985. RITONAVIR EP Impurity T
(2S)-N-[(1S,2S,4S)-1-benzyl-2-hydroxy-4-[[(2S)-3-methyl-2-
[[methyl[[2-(1-methylethyl)thiazol-4-
yl]mehtyl]carbamoyl]amino]butanoyl]amino]-5-
phenylpentyl]-3-methyl-2-[[methyl[[2-(1-
methylethyl)thiazol-4-yl]mehtyl]carbamoyl]amino]b
utanamide
O
HNHN
N
O
S N
HNO
HN
NOS
N
HO
986. Ritodrine Hydrochloride
EP Impurity A tyramine
987. Rivastigmine Rivastigmine
Related Compound A
(+)-Di-p-toluoyl-D-(+)-tartaric acid
O
O
O
HO
O
OH
O
O
988. Rivastigmine Rivastigmine
Related Compound C
((S)-3-[1-(Dimethylamino)ethyl]phenol)
N
HO
989. Rivastigmine Rivastigmine
Related Compound D
(3-Acetylphenyl ethyl(methyl)carbamate)
N
O
O
O
990. Rizatriptan RIZATRIPTAN
Impurity
N,N-Dimethyl-5-(1H-1,2,4-trizol-1-yl-methyl)-1H-indole-
3-ehanamine N-oxide (N-Oxide Impurity)
N
NH
NN
N
O
991. RIZATRIPTAN RIZATRIPTAN
Impurity
2-[5-(1H-1,2,4-triazol-1-yl-methyl)-1H-Inidole-3-
yl]ethanol NH
NN
N
HO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
992. Roflumilast ROFLUMILAST
Impurity
3,4-Bis(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-
yl)benzamide O
NHN
Cl
Cl
O
O
993. ROFLUMILAST ROFLUMILAST
Impurity 3,5-Dichloropyrdin-4amine NH2N
Cl
Cl
994. ROFLUMILAST ROFLUMILAST
Impurity 3-(Cyclopropylmethoxy)-4-
(difluoromethoxy)benzoicacid
O
OH
O
FF
O
995. ROFLUMILAST ROFLUMILAST
Impurity
N-(3,5-Dichloropropyridin-4-yl)-3,4-
bis(difluoromethoxy)benzamide
O
NH
O
F
F
N
Cl
Cl
O
F
F
996. ROFLUMILAST ROFLUMILAST
Impurity
3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl-
oxide)-4-difluoromethoxy)benzamide
(N-OXIDE)
O
NH
O
F
F
N
Cl
Cl
O
O
997. Ropinirole Impurity E 4-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-3-
(difluoromethoxy)benzamide O
NH
O
F
F
N
Cl
Cl
O
998. Ropinirole EP Impurity
D(3-oxo Ropinirole)
4-(2-(dipropylamino)ethyl)indoline-
2,3-dione ( Usp impurity B) HN
O O
N
999. Ropinirole EP Impurity A (Des propyl impurity)
4-(2-(propylamino)ethyl)indolin-2-
one
NH
O
NH
1000. Ropinirole N-oxide impurity
N-oxide impurity
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1001. Ropinirole Ropinirole Impurity
2-(2-Oxo-1,3-dihydro-4-indolyl)ethyl-p-
toulenesulphonate
NH
O
1002. Ropivacaine Hydrochloride Monohydrate
EP Impurity A (S)-bupivacaine
1003. Ropivacaine Hydrochloride Monohydrate
EP Impurity C
(-)-(2S)-N-(2,6-dimethylphenyl)-1-methylpiperidine-2-
carboxamide ((S)-mepivacaine),
N
O
HN
1004. Ropivacaine Hydrochloride Monohydrate
EP Impurity G
(+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-
ropivacaine),
N O
HN
1005. Ropivacaine Hydrochloride Monohydrate
EP Impurity H 2,6-dimethylaniline H2N
1006. Rosuvastatin N N-desmethyl
impurity N-desmethyl impurity
O
OH
OH OH
N
N
S
O
O
HN
1007. ROSUVASTATIN ROSUVASTATIN 5-Keto Impurity
(R)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl methyl
sulfonamide)pyrimidin-5-yl)hydorxy-5-oxoheptanoic acid(Rosuvastatin 5-OXO) O
OH
O OH
N
N
S
O
O
N
F
1008. ROSUVASTATIN ROSUVASTATIN
Lactone
N-(4-(4-fluorophenyl)-5-((E)-2-((2S,4R)-4-hydroxy-6-oxo-
tetrahydro-2H-pyran-2-yl)vinyl)-6-isoprppylpyrimidin-
2-yl)-N-methyl metanesulfonamide(Rosuvast
atin Lactone)
SO
ONN
N
O
O
HO
F
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1009. ROSUVASTATIN ROSUVASTATIN
Methyl ester
(3R,5S,E)-methyl7-(4-(4-fluorophenyl)-6-isopropyl-2-
(N-methyl methyl sulfonamide)pyrimidin-5-yl)-
3,5-dihydroxyhept-6-enoate(Rosuvastatin Methyl
Ester) O
O
OH OH
N
N
S
O
O
N
F
1010. Rufinamide RUFINAMIDE Ester Impurity
Ethyl-1-[(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-
carboxylate NNN
O
OF
F
1011. Salicylic Acid Salicylic Acid
Related Compound A
4-hydroxybenzoic acid O
HO
OH
1012. Sesame Oil Sesame Oil
Related Compound A
1,2-dilinoleoyl-3-oleoyl-rac-glycerol
1013. Sevoflurane Sevoflurane
Related Compound C
1,1,1,3,3,3-hexafluoro-2-propanol
HOF
FF
FF
F
1014. Sertraline Hydrochloride
EP Impurity A
(1RS,4SR)-4-(3,4-dichlorophenyl)-N-methyl-
1,2,3,4- tetrahydronaphthalen-1-
amine
NH
Cl
Cl
1015. SERTRALINE HYDROCHLORIDE
EP Impurity B
(1RS,4RS)-N-methyl-4-phenyl-1,2,3,4-
tetrahydronaphthalen-1-amine
NH
1016. SERTRALINE HYDROCHLORIDE
EP Impurity C
(1RS,4RS)-4-(4-chlorophenyl)-N-methyl-1,2,3,4-
tetrahydronaphthalen-1-amine
NHCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1017. SERTRALINE HYDROCHLORIDE
EP Impurity E (2R)-hydroxyphenylacetic acid
((R)-mandelic acid)
1018. SERTRALINE HYDROCHLORIDE
EP Impurity F (4R)-4-(3,4-dichlorophenyl)-
3,4-dihydronaphthalen-1(2H)-one
1019. SERTRALINE HYDROCHLORIDE
SERTRALINE Oxime Impurity
(+/-)-4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-
napthalenone.oxime
NHO
Cl
Cl
1020. SERTRALINE HYDROCHLORIDE
EP Impurity G
(1R,4R)-4-(3,4-dichlorophenyl)-N-methyl-
1,2,3,4-tetrahydronaphthalen-1-amine(sertraline enantiome)
1021. Sibutramine Sibutramine
Related Compound A
1-(1-(2-chlorophenyl)cyclobutyl)-N,N,3-trimethylbutan-1-
amine.Hcl
N
Cl
H
Cl
1022. Sibutramine Sibutramine
Related Compound B
1-(1-(3-chlorophenyl)cyclobutyl)-N,N,3-trimethylbutan-1-
amine.Hcl
N
Cl
H
Cl
1023. Sibutramine Sibutramine
Related Compound C
1-(1-(4-chlorophenyl)cyclobutyl)-N,N-dimethylpentan-1-amine.Hcl
N
Cl
HCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1024. Sibutramine Sibutramine
Related Compound D
1-(1-(4-chlorophenyl)cyclobutyl)-N,3-
dimethylbutan-1-amine.Hcl HNClH Cl
1025. Sildenafil Citrate EP Impurity B
4-{[4-Ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-1H-Pyrazolo[4,3-d]pyrimidin-5-
yl)phenyl]sulfonyl}-1-methylhexahydropyrozin-1-
ium-1-olate
N+
N
O-
S OO
N
HNN
N
O
O
1026. SILDENAFIL CITRATE EP Impurity D
4-Ethoxy -3-(6,7-dIhydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-
yl)benzenesulfonic acid(Demethylpiperazinyl Sildenafil Sulfonic Acid)
S OO
OH
N
HNN
N
O
O
1027. SILDENAFIL CITRATE SILDENAFIL
Dimer Impurity
5-{2-Ethoxy-5-[(4-{[4-ethoxy-3-(1-methyl-7-oxo-3-propyl-
6,7-dihydro-1Hpyrazolo[ 4,3-d]pyrimidin-5-
yl)phenyl]sulfonyl}piperazino)sulfonyl]phenyl}-1-methyl- 3-propyl-6,7-dihydro-1H-
pyrazolo[4,3-d]pyrimidin-7-one
N
HN
NN
O
S
O
O
N N S
O
O
N
NH
NN
O
OO
1028. SILDENAFIL CITRATE SILDENAFIL
Impurity
4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-
carboxamide
N
N
O NH2
O
HN
O
1029. SILDENAFIL CITRATE SILDENAFIL
Impurity 2-Ethoxy benzoic acid
O
HO
O
1030. SILDENAFIL CITRATE SILDENAFIL
Impurity 3-Ethoxy benzoic acid
O
OHO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1031. SILDENAFIL CITRATE SILDENAFIL
Impurity 4-Ethoxy benzoic acid
O
OH
O
1032. SILDENAFIL CITRATE SILDENAFIL
Impurity
4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-
carboxamide
N
N
O NH2
O
HN
O
1033. SILDENAFIL CITRATE SILDENAFIL
Impurity
5-(2 Ethoxy phenyl)-1-methyl-3-n-propyl-1,6-dihydro-7H-
pyrazolo[4,3- d]pyrimidine-7-one(Sildenafil
Lactam Impurity)
N
HNN
N
O
O
1034. SILDENAFIL CITRATE SILDENAFIL
Impurity
1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-Pyrazolo[4,3-
d]pyrimidine-5-yl)-4-ethoxyphenyl]sulfonyl]piperaz
ine(Sildenafil N-desmethyl Metabolite)
N
HN
S OO
O
HN
NN
N
O
1035. SILDENAFIL CITRATE SILDENAFIL
Impurity
1-Methyl-4-nitro-3-propyl-1H-pyrazole-5-
carboxamide(Sildenafil amide) NN
O
NH2
N+O-O
1036. SILDENAFIL CITRATE SILDENAFIL
Impurity
5-{2-Ethoxy-5-[(4-methypiperzino)sulfonyl]phen
yl}-3-ethyl-1-methyl-6,7-dihydro-1H-pyrazolo[4,3-
d]pyrimidin-7-one
N
N
S OO
N
HNN
N
O
O
1037. Silodosin Silodosin Impurity
(R)-1-(3-Hydroxypropyl)-5-[(2R)-({2-[2-[2-
(2,2,2trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-
dihydro-1H-indole-7-carbonitrile
N
HO
HN
O
OF F
F
N
1038. Silodosin Silodosin Impurity
(R)-3-(5-(2-Aminopropyl)-7-cyanoindolin-1-yl)propyl
benzoate tartate O
O
OH
HOO
OH
O
HO
N
N
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1039. Silodosin Silodosin Impurity
(R) -3-{7-Cyano-5-[2-({2-[2-(2,2,2-
Trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-
1H-indol-1-yl}propyl benzoate
O
ON
HN
O
O
F
F
F
N
1040. Simvastatin EP Impurity A
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-
dimethylbutanoyl)oxy]-2,6-dimethyl-
1,2,6,7,8,8ahexahydronaphthalen-1-yl]-3,5-
dihydroxyheptanoic acid (hydroxy acid)
O
OH
OH
OH
O
O
H
1041. Simvastatin EP Impurity B
(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(acetyloxy)-6-
oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-
1,2,3,7,8,8a-hexahydronaphthalen-1-yl
2,2-dimethylbutanoate (acetate ester)
O
OO
O
O
OH
1042. Simvastatin EP Impurity C
(1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-
1,2,3,7,8,8a-hexahydronaphthalen-1-yl
2,2-dimethylbutanoate (anhydrosimvastatin)
O O
O
O
H
1043. Simvastatin EP Impurity E
(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-
oxotetrahydro-2Hpyran- 2-yl]ethyl]-3,7-dimethyl-
1,2,3,7,8,8a-hexahydronaphthalen-1-yl
(2S)-2- methylbutanoate (lovastatin),
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1044. Simvastatin EP Impurity G
(1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-3-
methylene-1,2,3,7,8,8a-hexahydronaphthalen-1-yl
2,2-dimethylbutanoate
1045. Simvastatin Simvastatin
Anhydro sodium salt
Simvastatin Anhydro sodium salt(IH)
O O
HO
O
H
OH
1046. Sodium Fusidate 9,11-
anhydrofusidic acid
9,11-anhydrofusidic acid Impurity
1047. SODIUM FUSIDATE 11-deoxyfusidic
acid 11-deoxyfusidic acid Impurity
1048. Solifenacin Succinate
SOLIFENACIN Impurity
1-phenyl-3,4-dihydro isoquinoline N
1049. SOLIFENACIN SUCCINATE
SOLIFENACIN Impurity
(1S)-1-phenyl-1,2,3,4-tetrahydro-2-isoquinoline (S) NH
1050. Stavudine EP Impurity A 5-methylpyrimidine-
2,4(1H,3H)-dione
1051. STAVUDINE EP Impurity B
1-(2-deoxy-b-D-threo-pentofuranosyl)-5-
methylpyrimidine-2,4(1H, 3H)-dione(3-epithymidine)
HN
N
O
O
OH
O OH
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1052. STAVUDINE EP Impurity F
1-(3,5-anhydro-2-deoxy-b-D-threo-pentofuranosyl)-5-
methylpyrimidine-2,4(1H,3H)-dione
1053. STAVUDINE STAVUDINE
Impurity 3',5'-Di-(O-mesyl)-thymidine
O
O
ON
O
HN
O
SO
O
S
O
O
1054. STAVUDINE STAVUDINE
Impurity 5'Benzoyl-2',3'-didhydro-3'-
deoxythymidine ON
O
HN
O
O
1055. Strontium Renalate EP Impurity B
methyl 3-((methoxycarbonyl)methyl)-5-(bis((ethoxycarbonyl)methyl)a
mino)-4-cyanothiophene-2-carboxylate
S
O
O
N
N
O
OO
O
O
O
1056. Sulfacetamide Sodium
EP Impurity A sulfanilamide NH2S
O
O
H2N
1057. Sulfacetamide Sodium
EP Impurity B N-(4-
sulphamoylphenyl)acetamide
O
NHS
O
O
H2N
1058. Sulfacetamide Sodium
EP Impurity C N-[[4-
(acetylamino)phenyl]sulphonyl]acetamide
O
NH
S
O
O
HN
O
1059. Sulfacetamide Sodium
EP Impurity D dapsone.
1060. Sulfaguanidine EP Impurity A 4-
aminobenzenesulphonamide (sulphanilamide)
S
O
O
NH2H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1061. Sulfaguanidine EP Impurity B N-[(4-
aminophenyl)sulphonyl]urea (sulphacarbamide). N
HO
NH2
S
O
O
H2N
1062. Sulfamethoxazole EP Impurity D 4-aminobenzenesulphonic
acid (sulphanilic acid) S
O
O
OHH2N
1063. Sulfamethoxazole EP Impurity E 4-
aminobenzenesulphonamide (sulphanilamide)
S
O
O
NH2H2N
1064. Sulfasalazine EP Impurity H salicylic acid
HO
O
HO
1065. Sulfinpyrazone EP Impurity A 1,2-diphenyl-4-[2-
(phenylsulphonyl)ethyl]pyrazolidine-3,5-dione N N
OO
S OO
1066. Sulpiride EP Impurity A [(2RS)-1-ethylpyrrolidin-2-
yl]methanamine H2NN
1067. Sulpiride EP Impurity B methyl 2-methoxy-5-sulphamoylbenzoate
O
O
S
O
O
H2N O
1068. Sulpiride EP Impurity C ethyl 2-methoxy-5-
sulphamoylbenzoate
O
O
SO
O
NH2
O
1069. Sulpiride EP Impurity D 2-methoxy-5-
sulphamoylbenzoic acid
O
HO
S
O
O
H2N O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1070. Sulpiride EP Impurity E 2-methoxy-5-
sulphamoylbenzamide
O
H2N
S
O
O
H2N O
1071. Sulpiride EP Impurity F 1-ethyl-2-[[(2-methoxy-5-
sulphamoylbenzoyl)amino]methyl]pyrrolidine 1-oxide
N+
NH
O
S
O
O
H2N O -O
1072. Saquinavir Mesilate EP Impurity A
(2S)-4-Amino-4-oxo-2-[(quinolin-2-
ylcarbonyl)amino]butanoic acid
O
HO
HN
O
N O
NH2
1073. SAQUINAVIR MESILATE
EP Impurity B Ethyl(2S)-4-Amino-4-oxo-2-
[(quinolin-2-ylcarbonyl)amino]butanoate
O
O
HN
O
N O
NH2
1074. SAQUINAVIR MESILATE
EP Impurity C
(3S,4aS,8aS)-2-[(2R,3S)-3-Amino-2-hydroxy-4-phenylbutyl]-N-(1,1-
dimethylethyl)decahydroisoquinoline-3-carboxamide
N
O
HN
OH
H2N
H
H
1075. Tadalafil TADALAFIL
Impurity(Chloropretadalafil)
(IR,3R)-Methyl1,2,3,4-tetrahydro-2-chloroacetyl-
(3,4-methylenedioxyphenyl)-9H-Pyrido[3,4-6]indole-3-
carboxylate(Chloropretadalafil)
NH
N
O
O
Cl
O
CO2CH3
1076. Tadalafil TADALAFIL
Impurity( cis-Tadalafil)
(6R-12aS)-2,3,6,7,12,12a-Hexahydro-2-mehtyl-6-(3,4-
methylenedioxyphenyl)pyrazino[2,1:6]pyrido[3,4-6]indole-
1,4-dione(cis-Tadalafil)
NH
(R)
(S)
N
N
O
O
OO
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1077. Tadalafil Tadalafil
impurity(ent-tadalafil)
(6S-12aS)-2,3,6,7,12,12a-Hexahydro-2-mehtyl-6-(3,4-
methylenedioxyphenyl)pyrazilo[2,1:6]pyrido[3,4-6]indole-1,4-dione(ent-Tadalafil, L-
Tadalafil; L-Tildenafil)
NH
(S)
(S)
N
N
O
O
OO
1078. Tadalafil Tadalafil
Impurity(cis-ent-Tadalafil)
(6S-12aR) -2,3,6,7,12,12a-Hexahydro-2-mehtyl-6-(3,4-
methylenedioxyphenyl)pyrazilo[2,1:6] pyrid0 [3,4-6] indole -
1,4-dione(cis-ent-Tadalafil)
NH
(S)
(R)
N
N
O
O
OO
H
1079. Tamsulosin Hydrochloride
EP Impurity I 1-(2-bromoethoxy)-2-
ethoxybenzene O
OBr
1080. Telmisartan EP Impurity A 4-methyl-6-(1-methyl-1H-
benzimidazol-2-yl)-2-propyl-1H-benzimidazole
N
NH
N
N
1081. Telmisartan EP Impurity C
1,1-dimethylethyl 4¢-[[4-methyl-6-(1-methyl-1H-
benzimidazol-2-yl)-2-propyl-1Hbenzimidazol-1-
yl]methyl]biphenyl-2-carboxylate
1082. Telmisartan EP Impurity E
1-[(2¢-carboxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazol-6-carboxylic
acid
1083. Telmisartan EP Impurity F
4¢-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-
1H-benzimidazol-1-yl]methyl]biphenyl-2-
carboxamide
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1084. Telmisartan EP Impurity G
4¢-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-
1H-benzimidazol-1-yl]methyl]biphenyl-2-
carbonitrile
1085. Telmisartan EP Impurity H 1,1-dimethylethyl 4¢-
(bromomethyl)biphenyl-2-carboxylate
1086. Temazepam EP Impurity A 5-chloro-2-
(methylamino)phenyl]phenylmethanone,
ONH
Cl
1087. Temazepam EP Impurity B oxazepam
1088. Temozolomide Temozolomide
Impurity 5-Amino-1H-imidazole-4-
carboxamide hydrochlororide N
NH
O NH2
NH2
1089. Temozolomide Temozolomide
Impurity
5-Amino-1-(N-Methyl carbamoyl)imidazole-4-
carboxamide
N
N
O
NH2
HN
O
NH2
1090. Temozolomide Temozolomide
Related Compound C
diphenylcarbamic chloride N
O Cl
1091. Tenofovir Disoproxil Fumarate
TENOFOVIR Related
Compound A
[[(1S)-2-(6-Amino-9H-purin-9-yl)-1-methyl
ethoxy]methyl]phosphonicacid disoproxil fumarate(S-ISOMER)( (S)-Tenofovir Disoproxil Fumarate)
PO
O
O(S)
N
NN
N
H2N
O O
O
O
O O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1092. Tenofovir Disoproxil Fumarate
Tenofovir Related
Compound B
((E)-9-(Prop-1-enyl)-9H-purin-6-amine) N
N
NH2
N
N
1093. Tenofovir Disoproxil Fumarate
Tenofovir Related
Compound G
(R)-[[2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-
phosphonic acid isopropoxycarbonyl oxymethyl
ester isopropyl ester(Mono-POC Isopropyl Tenofovir)
ON
N
NN
H2NP
O O
O
O O
O
1094. Tenofovir Disoproxil Fumarate
Tenofovir Impurity
[[(1R)-1-(6-Amino-9H-purin-9-yl)propan-2-
yloxy]methylphosphonyl]methyl
isopropyl carbonate(Mono-POC Tenofovir)( Tenofovir
Monoisoproxil)
PO
OH
O
N
NN
N
H2N
O O
O
O
1095. Tenoxicam EP Impurity A pyridin-2-amine N
H2N
1096. Tenoxicam EP Impurity B methyl 4-hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-
3-carboxylate 1,1-dioxide SN
S
O
O
OH
OO
1097. Terazosin Hydrochloride Dihydrate
EP Impurity A 2-chloro-6,7-
dimethoxyquinazolin-4-amine
N
N
NH2
O
O
Cl
1098. Terazosin Hydrochloride Dihydrate
EP Impurity K prazosin
1099. Terazosin Hydrochloride Dihydrate
EP Impurity L 1-(furan-2-
ylcarbonyl)piperazine N
HN
O
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1100. Terazosin Hydrochloride Dihydrate
EP Impurity M 1,4-bis(furan-2-
ylcarbonyl)piperazine N
N
O
O
O
O
1101. Terazosin Hydrochloride Dihydrate
EP Impurity N 1-[[(2RS)-tetrahydrofuran-2-
yl]carbonyl]piperazine N
HN
O
O
1102. Terbinafine Hydrochloride
EP Impurity A N-methyl-C-(naphthalen-1-
yl)methanamine
NH
1103. Terbinafine Hydrochloride
EP Impurity B
(2Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-
2-en-4-yn-1-amine (cis-terbinafine)
1104. Terbinafine Hydrochloride
Terbinafine Impurity
1-Bromo-6,6-dimethyl hept-2-ene-4-yne Br
1105. Terbutaline Sulphate
EP Impurity A 3,5-dihydroxybenzoic acid (a-
resorcylic acid) O
HO
OH
OH
1106. Terfenadine EP Impurity I diphenyl(piperidin-4-
yl)methanol OH
NH
1107. Tetracaine Hydrochloride
EP Impurity A 4-aminobenzoic acid O
HO
NH2
1108. Tetracaine Hydrochloride
EP Impurity B 4-(butylamino)benzoic acid
O
OH
HN
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1109. Theophylline EP Impurity A caffeine
1110. Theophylline EP Impurity C
N-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-
tetrahydropyrimidin-5-yl)formamide
OHN
N
N
O
O
H2N
1111. Theophylline EP Impurity F etofylline
1112. Thiamazole EP Impurity B 1-methyl-1H-imidazole N
N
1113. Thiocolchicoside 3-demethyl
thiocolchicoside
3-O-demethyl thiocolchicine
O
NH
O
SO O
HO
1114. Tiabendazole EP Impurity A benzene-1,2-diamine H2N
H2N
1115. Tianeptine Sodium EP Impurity A ethyl 7-bromoheptanoate
O
O Br
1116. Tiapride Hydrochloride
EP Impurity A methyl 2-methoxy-5-
(methylsulphonyl)benzoate
O
O
S
O
O
O
1117. Tiapride Hydrochloride
EP Impurity C N,N-diethylethane-1,2-
diamine N
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1118. Tiaprofenic Acid EP Impurity D benzoic acid O
HO
1119. Ticlopidine Hydrochloride
EP Impurity C (2-chlorophenyl)methanamine
H2N
Cl
1120. Tiagabine Hydrochloride
Bis(3-methyl-2-thienyl) methanone
O
S
S
1121. TIAGABINE HYDROCHLORIDE
TIAGABINE Related
Compound A
(R)-Ethyl 1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]-3-
piperidine carboxylate(Tigabine ethyl
ester)
N
OO
S
S
1122. TIAGABINE HYDROCHLORIDE
TIAGABINE Related
Compound(Racemic Tiagabine)
((S)-(+),(R)-(-)-1-[4,4-bis(3-methyl-2-thienyl)-3-
butenyl]nipecotic acid, hydrochloride)( Racemic Tiagabine Hydrochloride
Mixture)
N
O OH
S
S
1123. Tilorone Hydrochloride
TILORONE Impurity
2,7-Dihydroxy-fluoren-9-one
O
HOOH
1124. TILORONE HYDROCHLORIDE
TILORONE Impurity
9-Fluorenone
O
1125. Tinidazole EP Impurity A 2-methyl-5-nitro-1H-imidazole N
HN
N+O
-O
1126. Tinidazole Tinidazole
Related Compound A
2-methyl-5-nitroimidazole N
HN
N+O
-O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1127. Tizanidine Hydrochloride
Tizanidine Related
Compound A
4-amino-5-chloro-2,1,3-benzothiadiazole N
SN
Cl
H2N
1128. Tolfenamic Acid EP Impurity A 2-chlorobenzoic acid O
HO
Cl
1129. Tolfenamic Acid EP Impurity B 3-chloro-2-methylaniline
H2N
Cl
1130. Tolnaftate EP Impurity A naphthalen-2-ol (b-naphtol), HO
1131. Tolnaftate EP Impurity D N,3-dimethylaniline NH
1132. Tolterodine Tarate TOLTERODINE
Impurity
2-Methoxy-5-methyl-N,N-bis(1-methylethyl)-gama-
phenylbenzene propanamine
N
O
1133. TOLTERODINE TARATE
TOLTERODINE S-ISOMER
2-[(1S)-3-[Bis(1-methylethyl)amino]-1-
phenylpropyl]-4-methylphenol(S-Tolterodine) N
OH
1134. Tolvaptan TOLVAPTAN
Impurity
(4-Amino-2-methylphenyl)(7-chloro-5-hydroxy-2,3,4,5-
tetrahydro-1H-1-benzo[b]azipin-1-
yl)methanone
N
OH
ClO
H2N
1135. TOLVAPTAN TOLVAPTAN
Impurity
2-Methyl-4-[(2-methylbenzoyl)amino]benzoic
acid
O
HO
NH
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1136. TOLVAPTAN TOLVAPTAN
Impurity
4-[(5-Hydroxy-2,3,4,5-tetrahydro-1H-1-benzazepine-
1-yl)carbonyl]-3-methylphenyl-2-
methylvenzamide
O
NH
O
N
OH
1137. TOLVAPTAN TOLVAPTAN
Impurity
7-chloro-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-5-oxo-2,3,4,5-tetrahydro-1H-
1-benzazepine
N
O
O
NH
OCl
1138. Tolterodine Tartrate TOLTERODINE
Impurity
2-Methoxy-5-methyl-N,N-bis(1-methylethyl)-gamma-
phenylbenzene propanamine N
O
1139. TOLTERODINE TARTRATE
TOLTERODINE S-ISOMER
2-[(2S)-3-[Bis(1-methylethyl)amino]-1-
phenylpropyl]-4-methylphenol tartaric acid
HO OH
O
O
O
OH
N
1140. Topiramate Topiramate
Related Compound A
2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-
fructopyranose
HO
O
OO
OO
1141. Torsemide TORSEMIDE
Related Compound A
[4-[(3-methylphenyl)amino]-3-pyridine sulfonamide]
N
S OO
H2N
HN
1142. TORSEMIDE TORSEMIDE
Related Compound B
[N-[(n-butylamino)carbonyl]-4-[(3-methylphenyl)amino]-3-
pyridinesulfonamide]
N
S
O
O HN
NH
O
HN
1143. TORSEMIDE TORSEMIDE
Related Compound C
[N-[(n-ethylamino)carbonyl]-4-[(3-methylphenyl)amino]-3-
pyridinesulfonamide]
N
S
O
O HN
NH
O
HN
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1144. Tramadol EP Impurity D (1RS,2RS)-2-
[(dimethylamino)methyl]-1-(3-hydroxyphenyl)cyclohexanol OHN
OH
1145. Tramadol EP Impurity E (2RS)-2-
[(dimethylamino)methyl]cyclohexanone N
O
1146. Tramadol Tramadol Related
Compound A
(+/-)-trans-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol
hydrochloride O
N
HClHO
1147. Tramadol Tramadol Related
Compound B
2-(dimethylaminomethyl)-1-cyclohexanone hydrochloride
O
N
H
Cl
1148. Tramadol Hydrochloride
EP Impurity E (2RS)-2-
[(dimethylamino)methyl]cyclohexanone N
O
1149. Tranexamic Acid EP Impurity D 4-aminomethylbenzoic acid O
HO
NH2
1150. Trandolapril TRANDOLAPRIL
Related Compound D
((S)-ethyl 2-[(3S, 5aS, 9aR, 10aS)-3-methyl-1,4-
dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]-4-phenylbutanoate)
O
ONN
O
O
H
HH
1151. TRANDOLAPRIL TRANDOLAPRIL
AT
(2S,3ar,7as)-1-[(2s)-2-[[(IS)-1-Carboxy-3-
phenylpropyl]amino]-1-oxopropyl]octahydro-1H-Indole-2-carboxylic acid
N
O
OH
O
NH
OHO
H
H
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1152. TRANDOLAPRIL TRANDOLAPRIL
Impurity
(2S,3aR,7aS)-benzyl octahydro-1H-indole-2-
carboxylate
HN
O
O
H
H
1153. TRANDOLAPRIL TRANDOLAPRIL
Impurity
(S)-2-((S)-1-(ethoxycarbonyl)-3-
phenylpropylamino)propanoic acid
O
NH
OO
OH
1154. Trapidil EP Impurity A 5-methyl-[1,2,4]triazolo[1,5-
a]pyrimidin-7-ol
N
N N
N
OH
1155. Trapidil EP Impurity B 1,2,4-triazol-3-amine NHN
NH2N
1156. Trazodone Hydrochloride
EP Impurity F 1-(3-chloropropyl)-
3chlorophenylpiperazine N
HN
C
Cl
Cl
1157. Triamterene EP Impurity A 5-nitrosopyrimidine-2,4,6-
triamine (nitrosotriaminopyrimidine), N
N
NH2
H2N
H2N
N
O
1158. Triamterene EP Impurity D phenylacetonitrile (benzyl
cyanide). N
1159. Tribenoside EP Impurity C benzaldehyde O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1160. Tribenoside EP Impurity D dibenzyl ether. O
1161. Trihexyphenidyl Hydrochloride
EP Impurity A 1-phenyl-3-(piperidin-1-
yl)propan-1-one O
N
1162. Trimetazidine Hydrochloride
EP Impurity A 1-(3,4,5-
trimethoxybenzyl)piperazine
N
HN
O
O
O
1163. Trimetazidine Hydrochloride
EP Impurity C 2,3,4-trimethoxybenzaldehyde
O
O
OO
1164. Trimetazidine Hydrochloride
EP Impurity D (2,3,4-
trimethoxyphenyl)methanol HO
O
OO
1165. Trimetazidine Hydrochloride
EP Impurity G piperazine NH
HN
1166. Trimethoprim EP Impurity H methyl 3,4,5-
trimethoxybenzoate O
O
O
O
O
1167. Trimethoprim EP Impurity J 3,4,5-trimethoxybenzoic acid O
OH
O
O
O
1168. Trimethoprim EP Impurity K aniline. H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1169. Trimipramine Maleate
EP Impurity D imipramine,
N
N
1170. Trimipramine Maleate
EP Impurity F 10,11-dihydro-5H-
dibenzo[b,f]azepine NH
1171. Tropicamide EP Impurity A N-(pyridin-4-
ylmethyl)ethanamine HN
N
1172. Tropicamide EP Impurity B N-ethyl-2-phenyl-N-(pyridin-4-
ylmethyl)propenamide
O
N
N
1173. Tropicamide EP Impurity C (2RS)-3-hydroxy-2-
phenylpropanoic acid (tropic acid).
O
OH
OH
1174. Tryptophan EP Impurity C (S)-2-amino-4-(2-
aminophenyl)-4-oxobutanoic acid (kynurenine),
O
OH
ONH2 NH2
1175. Tryptophan EP Impurity D (S)-2-amino-3-(5-hydroxy-1H-indol-3-yl)propanoic acid (5-
hydroxytryptophan), OOH N
H
OH
H2N
1176. Tryptophan Tryptophan
Related Compound B
N-Acetyl-L-Tryptophan HN
NH
O
HO
O
1177. Valacyclovir EP Impurity A 2-Amino-1,9-dihydro-6H-
purin-6-one N
NH
N
HN
O
H2N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1178. Valacyclovir EP Impurity B 2-Amino-9-[(2-
hydroxyethoxy)methyl]-1,9-dihydro-6H-Purin-6-one
N
N
NNH
O
OHO
NH2
1179. Valacyclovir Valacyclovir
Impurity
2-[[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-
yl)methoxy]ethyl]N-methyl-L-valinate
NH
O
O
O
N
NN
HN
O
H2N
1180. Valacyclovir Valacyclovir
Impurity
2-[[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-
yl)methoxy]ethyl]N-methyl-L-alaninate
NH2
O
O
O
N
NN
HN
O
H2N
1181. Valacyclovir Valacyclovir
Impurity
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-
yl)Methoxy]ethyl N-formyl-L-valinate
NH
O
O
O
O
N
NN
HN
O
H2N
1182. Valacyclovir Valacyclovir
Related Compound G
N,N-dimethylpyridin-4-amine N N
1183. Valproic Acid Valproic Acid
Related Compound A
diallyl acetic acid O
O
1184. Valsartan Valsartan Related
Compound B
(S)-N-butyryl-N-{[2’-(1-H-tetrazole-5-yl)-biphenyl-4- yl]-
methyl}-valine]
N
O
O
O
NH
NN
N
1185. Valsartan Valsartan Related
Compound C
(S)-N-valeryl-N-{(2-(1H-tetrazole-5- yl)-biphenyl-4- yl]-
methyl}-valine benzyl ester]
N
O
O
O
NH
NN
N
1186. Valsartan Valsartan IH
impurity
[S]-methyl-2-((2'-cyanobiphenyl-4-yl) ethyl
amino)-3-methylbutanoate HCl
NH
O
OCN
HCl
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1187. Valsartan Valsartan IH
impurity
(S)-methyl-2-(N-((2’-Cyano biphenyl -4- yl)methyl)
pentanamido)-3- methylbutanoate
N
O
OCN
O
1188. Valsartan Valsartan IH
impurity
S)-2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl
amino)-3-methylbutanoic acid
NH
O
HO NH
NN
N
1189. Valsartan Valsartan IH
impurity
(S)-methyl 2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl
amino)-3-methylbutanoate
NH
O
O NH
NN
N
1190. Valsartan Valsartan IH
impurity
(S)-methyl 2-(N-((2’-(1H-tetrazole-5-yl)biphenyl-4-
yl)methyl)pentanomido)-3-methylbutanoate
N
O
O
O
NH
NN
N
1191. Valsartan Valsartan IH
impurity
(S)-2-[N-((2’-cyanobiphenyl-4-yl)Methyl)pentanamido]-3-
Methyl butanoic acid
N
O
HOCN
O
1192. Valsartan Valsartan Related
Compound A
(R)-N-valeryl-N-([2’-[1H-tetrazole-5-yl] biphenyl-4-yl]-
methyl)-valine
(R)
N
O
O
O
NH
NN
N
1193. Vardenafil Hydrochloride
VARDENAFIL Impurity
2(2-ethoxyphenyl)-5-methyl-7-propyl-3,4-
dihydroimidazo[5,1-f][1,2,4]triazin-4-one
N
NH
NN
OO
1194. VARDENAFIL HYDROCHLORIDE
VARDENAFIL Impurity
4-[2-Ethoxy-5-(4-ethylpiperazin-1-yl)sulfinyl-
phenyl]-9-methyl-7- propyl-3,5,6,8-
tetrazabicyclo[4.3.0]nona-3,7,9-trien-2-one
N
NH
NN
O
SO
NN
O
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1195. Verapamil Verapamil
Related Compound E
3,4-dimethoxybenzaldehyde
O
O
O
1196. Verapamil Verapamil
Related Compound F
3,4-Dimethoxybenzyl alcohol O
O
HO
1197. Voriconazole VORICONAZOLE
Related Compound B
(2S,3R)-2-(2,4-Difluorophenyl)-3-(5-fluoro-4-
pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
OH
N
N
N
NN
F
F
F
1198. VORICONAZOLE VORICONAZOLE
Related Compound C
1-(2,4-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone N
N
N
F
F O
1199. VORICONAZOLE VORICONAZOLE
Impurity
(2R,3S)/(2S,3R)-3-(5-Fluoro-6-chloro-pyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-
triazol-1-yl)butane-2-ol
HO
NN
N
F
FN N
Cl
F
1200. Zaltoprofen ZALTOPROFEN
Impurity
2-(10,11-Dihydro-10-oxodibenzo[b,f]thiepin-2-
yl)propionicacid methyl ester
O
O
S
O
1201. ZALTOPROFEN ZALTOPROFEN
Impurity
2-(3-(Carboxymethy)-4-(phenylthio)phenyl)propanic
acid O
OH
S
OHO
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1202. ZALTOPROFEN ZALTOPROFEN
Impurity
2-propionyl-10,11-dihydrodibenzo[b,f]thiepin-
10-one S
O
O
1203. Zidovudine EP Impurity C 5-methylpyrimidine-
2,4(1H,3H)-dione NH
NH
OO
1204. Zidovudine Zidovudine
Related Compound A
Triphenyl methanol OH
1205. Zidovudine Zidovudine
Related Compound C
thymine NH
ONH
O
1206. Zidovudine Zidovudine
Impurity 5-Methyl pyrimidine-
2,4(1H,3H)-dione amine N
HN
O
OH2N
1207. Ziprasidone ZIPRASIDONE
Related Compound A
1-(1,2-Benzisothiazol-3-yl)piperazine N
HN
SN
1208. ZIPRASIDONE ZIPRASIDONE
Impurity 6-Chloro-5-(2-
chloroethyl)oxindole
HN
O
Cl
Cl
1209. Zoledronic Acid ZOLEDRONIC ACID Related Compound A
Ethyl imidazole-1-yl-acetate O
O
N
N
Sl. No. API IMPURITY CHEMICAL NAME STRUCTURE
1210. ZOLEDRONIC ACID ZOLEDRONIC ACID Impurity
Imidazole N
HN
1211. Zolmitriptan ZOLMITRIPTAN
R-Isomer
((R)-4-({3-[2-(Dimethylamino)ethyl]indol-5-
yl}methyl)oxazolidin-2-one) O
HNO
HN
N
1212. ZOLMITRIPTAN ZOLMITRIPTAN
Impurity (S)-4-(4-Amino benzyl)-2-
oxazolidinone hydrochloride O
HN
ONH2
HCl
1213. ZOLMITRIPTAN ZOLMITRIPTAN
Related Compound B
((S)-2-Amino-3-{3-[2-(dimethylamino)ethyl]-1H-
indol-5-yl}propan-1-ol)
OH
NH
N
NH2
1214. Zonisamide Zonisamide
Related Compound A
1,2-Benzisoxazole-3-methane sulfonic acid sodium salt
Na+
ON
S
O
O-O
1215. Zonisamide Zonisamide
Impurity 1,2-Benzisoxazole-3-acetic
acid
ON
O
OH
1216. Zonisamide N-methyl impurity
N-methyl Zonisamide S
O
O
NH
ON
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