Impurities product list

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
N
H
O
3. Acetazolamide EP Impurity C
2- (acetyl.amino)-1,3,4-
thiadiazole-5-thiol S
N N
SH
N
H
O
4. Acetazolamide EP Impurity D
S
NN
S
O
O
H2N NH2
5. Acetazolamide Acetazolamide
2-(acetyl amino)-1,3,4-
thiadiazole-5 sulfonamide S
NN
S
O
O
H2N 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
F
F
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

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
N
N
HN
O
H2N
11. Adefovir Dipivoxil
Adefovir
Dipivoxil
9-[[[2-hydroxyphosphonyl]
methoxy] ethyl]adenine
N
N
H2N
N
N
O
HO
P
O
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

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
N
O
H2N
HN
O
23. Allopurinol
Allopurinol
Related
Compound C
5-(4H-1,2,4-triazol-4-yl)-1H-
pyrazole-4-carboxamide
NH
N
O
H2N
N
N
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
HN
N
O
ON
HO
26. Allopurinol
Allopurinol
Related
Compound F
(ethyl-(E/Z)-3-(2-carbethoxy-2-
cyanoethenyl)amino-1H-
pyrazole-4-carboxylate)
HN N
O O
N
H
N
O
O

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
OH
N
H
(R)
O
N
(R)
(R)
HO
30. ALVIMOPAN
ALVIMOPAN
Impurity
1-hydroxy benzo triazole N
N
N
OH
31. ALVIMOPAN
ALVIMOPAN
Impurity
(2S,3R,4R)-4-(3-
Hydroxyphenyl)-3,4-dimethyl-
alpha-(phenylmethyl)-1-
piperidine propanoic
acid(Alvimopan Metabolite)
N
O
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
O
O 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

34.
Amiodarone
Hydrochloride
Amiodarone
Related
Compound D
((2-butylbenzofuran-3-yl)(4-
hydroxy-3,5-
diiodophenyl)methanone) O I
I
OH
O
35.
Amiodarone
Hydrochloride
Amiodarone
Related
Compound E
((2-butylbenzofuran-3-yl)(4-
hydroxyphenyl)methanone)
O
OH
O
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
N
H
O
O O
O
Cl

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
O
N
H
O
H
NO
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-
dicarboxylate
NH
O
O
O
O
O N
O
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
O
NH2
43. Amlodipine EP Impurity F
dimethyl 2-((2-
aminoethoxy)methyl)-4-(2-
chlorophenyl)-1,4-dihydro-6-
methylpyridine-3,5-
dicarboxylate benzene
sulfonate
H
N
O
O
O
O
Cl
O
NH2
44. Amlodipine EP Impurity E
diethyl 2-((2-
methylpyridine-3,5-
dicarboxylate
benzenesulphonate
H
N
O
O
O
O
Cl
O
NH2

45. Amlodipine EP Impurity I
3-ethyl 5-methyl 2-((2-
methylpyridine-3,5-
dicarboxylate
H
N
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
O
NH2
.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

51. Amoxicillin
Amoxicillin
Related
Compound C
((4S)-2-[5-(4-hydroxyphenyl)-
3,6-dioxopiperazin-2-yl]-5,5-
dimethylthiazolidine-4-
carboxylic acid)
S
H
N 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)
H
N
N
N
O

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
H
N
O
OHO
N
O
60. Anastrozole Anastrozole
2,2'-[5-(4H-1,2,4-Triazol-4-
ylmethyl)-1,3-phenylene]di(2-
methylpropiononitrile) N
N
NN
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
H
O O
OH
63. Aripiprazole EP Impurity D
Bis-(3,4 dihydrocarbostyril-7-
oxy) 1,4 butane
N
H
O O
O
H
N O
64. Aripiprazole EP Impurity E
7-(4-Chlorobutoxy)-3,4-
dihydroquinolin-2-one N
H
O O
Cl

65. Aripiprazole
USP
Aripiprazole
quinoline
impurity
7-Hydroxy-3,4-
dihydroquinolin-2(1H)-one N
H
O 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
H
O 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

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 N
H
N
NH
O
O N
F
O
F
F
F
F
F
F
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
F
F
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,1
2aR)-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
O
O
HN
NH

77.
Articaine
Hydrochloride
Articaine
Related
Compound E
(Methyl 3-[2-
(isopropylamino)propanamido
]-4-methylthiophene-2-
carboxylate)
S
O
O
O
N
H
H
N
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 N
H
H
N
O
O
82. Aspartame Aspartame
83. Aspartame
Aspartame
Related
Compound A
(5-Benzyl-3,6-dioxo-2-
piperazineacetic Acid) N
H
H
N
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

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)aceta
mide
O
H2N
O
OH
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
H
N
Ph
(R) (S) O
OH OH O
Ca
+2
F

94. Atorvastatin EP Impurity D
3-(4-Fluorobenzoyl)-2-
isobutyryl-3-phenyl-oxirane-2-
carboxylic acid phenylamide
O
O
HN
O
O
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-
O
OH
OH 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-
O
OH
OH 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-
calcium salt
Ca++
O
O-
OH OH
O
H
N
OH OH
N
HN
O
F
98. Atorvastatin
Ep Impurity
G(Ats-3-O-
methyl)
(3R,5R)-7-(3-
phenyl-1H-pyrrol-1-yl)-5-
hydroxy-3-methoxyheptanoic
acid calcium salt
N
O
H
N
Ph
(R) (R) O
OH O O
Ca
+2
F

99. Atorvastatin
Atorvastatin
Acetonide
impurity
2-((4R,6R)-6-(2-(3-
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-
phenyl-1H-pyrrol-1-yl)-3,5-
dihydroxyheptanoate
N
O
H
N
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-
calcium salt)
N
O
H
N
Ph
(R) (R) O
OH OH O
Ca
+2

104. Atorvastatin
Atorvastatin
Related
Compound B
(3S,5R isomer, or (3S,5R)-7-[3-
phenyl-1H-pyrrol-1-yl]-3,5-
calcium salt)
N
O
H
N
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-
calcium salt)
O
OH
OH OH
N
F
F
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
O
O
F
107. Atorvastatin
Atorvastatin
Related
Compound E
(3S, 5S enantiomer of
Atorvastatin Calcium) N
O
H
N
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-
phenylpropylaminehydrochlor
ide
NH O

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
O
NH2
O
O
OO
O
O
O
116. Azelastine EP Impurity A benzoyldiazane
NHH2N
O

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
N
H
N
OCl
119. Azelastine EP Impurity A
benzoyldiazane
(benzohydrazide), NHH2N
O
120. Azelastine EP Impurity D
4-(4-chlorobenzyl)phthalazin-
1(2H)-one
N
H
N
OCl
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)

126. Azithromycin EP Impurity F
-N-demethyl-
Nformylazithromycin
127. Azithromycin EP Impurity G
-N-demethyl- -N-[(4-
methylphenyl)sulphonyl]azithr
omycin
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

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
N
Cl
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]ph
enoxy]-2 methylpropanoate O
O
O
NH
O
Cl
141. Bezafibrate EP Impurity D
ethyl 2-[4-[2-[(4-
enoxy]-2-methylpropanoate O
O
O
HN
O
Cl

142. Bezafibrate EP Impurity E
butyl 2-[4-[2-[(4-
enoxy]-2-methylpropanoate
O
O
O
NH
O
Cl
143. Bicalutamide EP Impurity A
Defluoro Bicalutamide
impurity
O
NH
OH
S
O
O
F
F
F
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
NH
OH
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
F
F
N
147. Bicalutamide EP Impurity J
N-[4-Cyano-3-
(trifluoromehtyl)phenyl]-3-[(4-
fluorophenyl)thio]-2-hydroxy-
2-methylpropanamide
O
HN
OH
S
F
F
F
F
N
148. Bicalutamide EP Impurity C
N-[4-Cyano-3-
(trifuoromethyl)phenyl]-3-[(4-
methylpropanamide
O
NH S
O
O
FF
F
F
N

149. Bicalutamide EP Impurity D 4-Amino -2-(trifluoromethyl)
benzonitrile
N
F
F
F
H2N
150. Bicalutamide EP Impurity
N-[4-Cyano-3-
hydroxy-2-methyl-
propanamide
O
HN
OH
S
O
F
F
F
F
N
N-[4-Cyano-3-
Acetyloxy-2-methyl-
propanamide
O
HN
O
O
S
O
F
F
F
F
N
2,3-Epoxy-2-mehyl-N-[4-
Cyano-3-
(trifluoromethyl)phenyl]propa
namide
O
H
N
F
F
F
N
O
N-[4-Cyano-3-
(trifluoromehyl)phenyl]-3-[(4-
hydroxy-2-
methylpropanamide
O
NH
OH
S
O
O
FF
F
F
N
154. Bicalutamide EP Impurity 4-Amino -3-
(trifluoromethyl)benzonitrile
N
F
FF
H2N

155. Bisoctrizole
Bisoctrizole
Related
Compound A
(2-(2H-Benzotriazol-2-yl)-4-
(1,1,3,3-tetramethylbutyl)
phenol)
OH
N
N
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
N
O
H
N
NH2
O
158. BORTEZOMIB
BORTEZOMIB
Impurity
N-(Pyrazine-2-ylcarbonyl)-L-
Phenylalanine
H
N
O
HOO
N
N
159. BORTEZOMIB
BORTEZOMIB
Impurity
[(1(R)-3-methyl-1-[[(2R)-1-
oxo-3-phenyl-2-
[(pyrazinylcarbonyl)amino]pro
pyl]
amino]butyl] boronicacid N
N
N
H
O
H
N
O
B
OH
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

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
O
N
H
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
O
N
H
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
HN
O
N N
NN
O
O
S
O
O
H
N
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

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

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

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
NN
H
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]pentane
dioic acid
O
OH
O
HO
HN
O
H2N

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-
yl]methyl]-2,3-dihydro-1H-
benzimidazole-4-carboxylate
193.
Candesartan
Cilexetil
EP Impurity C
(1RS)-1-
ethyl 3-[[2′ -(1-ethyl-1H-
yl]methyl]-2-oxo-2,3-dihydro-
1H-benzimidazole-4-
carboxylate
194.
Candesartan
Cilexetil
EP Impurity D
(1RS)-1-
ethyl 3-[[2′ -(2-ethyl-2H-
yl]methyl]-2-oxo-2,3-dihydro-
1H-benzimidazole-4-
carboxylate
195.
Candesartan
Cilexetil
EP Impurity E
(1RS)-1-
ethyl 2-ethoxy-1-[[2′ -(1-ethyl-
1H-tetrazol-5-yl)biphenyl-4-
7-carboxylate

196.
Candesartan
Cilexetil
EP Impurity F
(1RS)-1-
ethyl 2-ethoxy-1-[[2′ -(2-ethyl-
2H-tetrazol-5-yl)biphenyl-4-
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-
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

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
HO
OH
N
H
N
F
O O
O
203. CAPECITABINE
Capecitabine
Impurity
5'-Deoxy-5-fluoro-N4-(3-
methyl-1-
butyloxycarbonyl)cytidine
O
HO
OH
N
H
N
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)
N
H
207. Carbaryl EP Impurity A 1-naphthol
OH

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
N
SH
211. Carboplatin EP Impurity A cisplatin
212. Carboplatin EP Impurity B
cyclobutane-1,1-dicarboxylic
acid
OHO
O
OH
213. Carprofen Carprofen
214. Carprofen
Carprofen
Related
Compound A
9H-carbazole
H
N
215. Carvedilol Carvedilol

216. Carvedilol
Carvedilol
Related
Compound D
(4-(Oxiran-2-ylmethoxy)-9H-
carbazole)
N
H
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

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
H
N
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
NH2
N
N
F
FF

231. CELECOXIB
CELECOXIB
Related
Compound B
(4-[3-(4-methylphenyl)-5-
(trifluoromethyl)-1H-pyrazol-
1-yl]benzenesulfonamide) EP-
A
S
O
O
NH2N
N
F
F
F
232. CELECOXIB EP Impurity D
(4-[3-(2-methylphenyl)-5-
(trifluoromethyl)-1H-pyrazol-
1-yl]benzenesulfonamide)
S
O
O
NH2N
N
F
F
F
233. CELECOXIB
CELECOXIB
ISOMER
4-[4-(4'-Methylpenyl)-3-
(trifluoromethyl)-1H-
PYRAZOL-1-yl]-
benzensulfonamide
S
O
O
H2N N
N
F
F F
234. CELECOXIB
CELECOXIB
REGEIO
ISOMER
CELECOXIB REGEIO ISOMER N
N
S
NH2
O
O
H3C
CF3
235. CELECOXIB
CELECOXIB
METABOLITE
4-[2-hydroxy-5-
(4'Methylphenyl)-3-(tri
fluoromethyl)-1H-pyrazol-1-
yl]-benzenesulfonamide
S
O
O
NH2
N
N
F
F
F
HO
236. CELECOXIB
CELECOXIB
Impurity
[5-(4-Methylphenyl)-3-tri
fluoromethyl-1H-pyrazole]
N
H
N
F
F
F
237. Cetirizine EP Impurity A
(RS)-1-[(4-
chlorophenyl)phenylmethyl]pi
perazine
NHN
Cl
238. Cetirizine EP Impurity B
(RS)-2-[4-[(4-
perazin-1-yl]acetic acid O
OH
N
N
Cl

239. Cetirizine EP Impurity C
(RS)-2-[2-[4-[(2-
perazin-1-yl]ethoxy]acetic acid
O
OH
O
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]butane
nitrile
N
N
N
Cl
244.
Chlorphenamine
Maleate
EP Impurity B
N-(pyridin-2-yl)pyridin-2-
amine (2,2¢-dipyridylamine)
N
N
H
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
N
N
Cl
247. Chlorzoxazone
Chlorzoxazone
Related
Compound A
2-Amino-4-chlorophenol
Cl NH2
OH

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
H
N O
HO
251. Cilostazol
Cilostazol
Related
Compound B
6-[4-(1-Cyclohexyl-1H-
tetrazol-5-yl)-butoxy]-1H-
quinolin-2-one HN
O
O
N
N
N
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

257.
CINACALCET
HYDROCHLORIDE
CINACALCET
HYDROCHLORI
DE
(R)-alpha-Methyl-N-[3-[3-
(trifluoromethyl)phenyl]methy
l]-1-
napthalenemethane amine
hydrochloride
H
N
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
H
N
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
H
N
H2N
263.
Ciprofloxacin
Hydrochloride
EP Impurity A
7-chloro-1-cyclopropyl-6-
fluoro-4-oxo-1,4-
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
OH
F
N

265. Citalopram
Citalopram
Related
compound A
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-
carbonitrile
O
N
HN
F
267. Citalopram
Citalopram
Related
compound E
1-(3-dimethylaminopropyl)-1-
(4-fluorophenyl)-1,3-
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-(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),
H
N
NN
N
NH2
Cl
271. Cladribine EP Impurity E
2-deoxy-D-erythro-
pentofuranose (2-deoxy-D-
ribose),
OH
HO
O
HO
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

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, NH
N
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

283. Clopamide EP Impurity C
4-chloro-3-sulfamoylbenzoic
acid,
O
HO
S
O
O
NH2
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
S
O
O
OH
Cl
287. Clotrimazole EP Impurity A
(2-
chlorophenyl)diphenylmethan
ol,
OH
Cl
288. Clotrimazole EP Impurity D imidazole N
HN
289. Clotrimazole EP Impurity E
(2-chlorophenyl)
phenylmethanone (2-
chlorobenzophenone),
OCl

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
H
N
Cl Cl
H
Cl
294.
CYCLOBENZAPRINE
HYDROCHLORIDE
CYCLOBENZAPR
INE Related
Compound A
5-(3-Dimehylaminopropyl)-5-
hydroxydibenzo[a,e]cyclo
heptatriene
OH
N
295.
CYCLOBENZAPRINE
HYDROCHLORIDE
CYCLOBENZAPR
INE Impurity
5H-Dibenzo[a,d]cyclohepten-
5-ol
OH
296. Dacarbazine EP Impurity B
5-amino-1H-imidazole-4-
carboxamide,
N
NH
O
H2N
H2N
297. Dacarbazine
Dacarbazine
Related
Compound A
5-aminoimidazole-4-
carboxamide hydrochloride
N
NH
O
H2N
H2N
H
Cl

298. Dacarbazine
Dantrolene
Related
Compound C
5-(4-nitrophenyl)-2-
furancarboxyaldehyde OO
N+
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
O
N
OH
H2N
NH2
302. DARUNAVIR
DARUNAVIR
Impurity
[(1S,2S)-3[[(4-Amino-
phenyl)sulfonyl](2-
methylpropyl)amino]-2-
hydroxy-1-
(phenylmethyl)propyl]carbami
c acid(3R,3aS,6aR)-
hexahydrofuro[2,3-b]-furan-
3ylester
NH
O
O
OHNS
O
O
H2N
O
O
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

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
N
H
308. Desloratadine
N-oxide
impurity
N-oxide impurity
N
N
H
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
F
F
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
F
F
OH

Dexlansoprazol
e Impurity
2-[[[3-Methyl-4-(2,2,2-
trifluoroethoxy)-2-
pyridinyl]methyl]thio]-1H-
benzimidazole( Sulfide
impurity)
N
N
H
S
N
O
F
F
F
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
F
FO
313. Dexpramipexole
Dexpramipexol
e Impurity A
(6R)-4,5,6,7-tertrahydro-1,3-
benzothiazol-2,6-diamine
S
N
H2N
NH2
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
N
H
O
315. Dexpramipexole
Dexpramipexol
e Impurity C
(S)-4,5,6,7-terahydro-N-6-
propyl-2,6-
benzothiazolediamine
S
N
(S) NH2
N
H
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
N
H
317. Dexpramipexole
Dexpramipexol
e Impurity
(R)-4,5,6,7-tetrahydro-N2,N6-
dipropylbenzo[d]thiazole-2,6-
diamine
S
N
(R) NH
N
H
318.
Dextroamphetamin
e
Dextroampheta
mine Related
Compound A
1-Phenyl-2-propanol
OH

319.
Dextroamphetamin
e
Dextroampheta
mine 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]phenyl
methanone
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
N
H
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]benzald
ehyde
ONH
Cl
Cl
326. Dicloxacillin Sodium EP Impurity C 6-aminopenicillanic acid NH
S
O
O
OH
H2N

327. Didanosine EP Impurity A hypoxanthine
H
N
NN
N
OH
328. Didanosine EP Impurity B inosine
OH
OH
HO
O
N
N
HO
N N
329. Didanosine EP Impurity C 2'-deoxyinosine
HO
HO
O
N
N
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
O
AcO
332. Didanosine
Didanosine
Related
Compound A
Hypoxanthine
H
N
NN
N
OH
333. Didanosine
Didanosine
Related
Compound B
2',3'-dideoxyadenosine
HO
O
N
N
NH2
NN
334.
Diethylcarbamazine
Citrate
EP Impurity A 1-methylpiperazine N NH

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

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)
H
N
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
N
N
N
N
N
N
N
OHHO
OH
HO
OH
OH

351. Dipyridamole EP Impurity A
2,2¢-[[4,6,8-tri(piperidin-1-
yl)pyrimido[5,4-d]pyrimidin-2-
yl]nitrilo]diethanol,
N
N
N
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
N
N
N
N
HN
OH
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
N
N
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
N
N
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
N
N
N
N
N
Cl
N
OH
OH

356. Dipyridamole EP Impurity G
2,6-dichloro-4,8-di(piperidin-
1-yl)pyrimido[5,4-d]pyrimidine
N
N
N
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
N
N
N
N
N
N
OHHO
OH
OH
358. Dipyridamole
Tetrachloro
impurity
2,4,6,8-
Tetrachloropyrimidopyrimidin
e
N
N
N
N
Cl
Cl
Cl
Cl
359. Dipyridamole
Dichloro
impurity
Dipyridamole dichloro
impurity
N
N
N
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
N
H
O

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
N
H
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

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-
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-
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

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
HN
N
O
Cl
375. Domperidone EP Impurity B
4-(5-chloro-2-oxo-2,3-dihydro-
1H-benzimidazol-1-yl)-1-
formylpiperidine
N
O
HN
N
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
O
O
Impurity
1-Benzyl-4-[(5,6-dimethoxy-
1H-inden-
2yl)methyl]piperidine
N O
O
Impurity
5,6-Dimethoxy-2-(4-
pyridyl)methyl-indan-1-one
O
N
O
O

Impurity
2,3-Dihydro-5,6-dimethoxy-2-
[(4-pyridinyl)methylene-1H-
inden-1-one O
O
O
Impurity
1-Benzyl-4-[(5,6-dimethoxy-
2,3-dihydro-1H-indan-
2yl)methyl]piperidine
N O
O
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

388.
DORIPENEM
MONOHYDRATE
DORIPENEM
Impurity
4-NITROBENZYL (4R,5S,6S)-6-
[(1R)-1-HYDROXYETHYL]-4-
METHYL-3-[[(3S,5S)-1-(4-
NITROBENZYLOXYCARBONYL)-
5-
(SULFAMOYLAMINOMETHYL)P
YRROLIDIN-3-YL]THIO]-7-OXO-
1-AZABICYCLO[3.2.0]HEPT-2-
ENE-2-CARBOXYLATE
N
O
O
O
S
N
N
H
S
O
O NH2
O
O N
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
H
N
S
O
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 N
O
-
O
O
OH
OP
O
O
O
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-
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-
sulfonamide-7,7-dioxide
(S)
(S)
S S
OO
S
O
O
NH2
HN O

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

402. Doxazosin Mesilate EP Impurity D
6,7-dimethoxyquinazoline-
2,4(1H,3H)-dione
H
N
NH
O
O
O
O
403. Doxazosin Mesilate EP Impurity E
2,4-dichloro-6,7-
N
N
O
O
Cl
Cl
404. Doxazosin Mesylate
Doxazosin
Related
Compound B
6,7-dimethoxyquinazoline-2,4-
dione
H
N
NH
O
O
O
O
Doxazosin
Related
Compound C
2-chloro-4-amino-6,7-
N
N
O
O
NH2
Cl
Doxazosin
Related
Compound D
1,4-benzodioxane-2-carboxylic
acid
O
OO
HO
Doxazosin
Related
Compound E
2,4-dichloro-6,7-
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

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
H
N
SO
414.
DULOXETINE
HYDROCHLORIDE
EP Impurity
(R-ISOMER)
(R)-N-methyl-3-(1-
naphthyloxy)-3-(2-
thienyl)propanamine( R-
ISOMER)
(R)
H
N
S
O
415. Ebastine EP Impurity A
diphenylmethanol
(benzhydrol),
OH
416. Ebastine EP Impurity B
1-[4-(1,1-
dimethylethyl)phenyl]ethanon
e
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

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
FF
Cl
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) N
H
O
O
F
F
F
Cl
425. EFAVERINZ EFAVERINZ
Impurity
(S)-6-Chloro-4-pent-1-inyl-4-
trifluoro methyl-1,4-
dihydrobenzo[d]-1,3-oxazin-
one N
H
O
O
F
F F
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

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
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
S
O
O
N
N
O
F
NH2
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
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
O
O
S
HO
F
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]propanoy
l)pyrrolidine-2-carboxylic acid
435. Enalapril Maleate EP Impurity I 1H-imidazole N
HN

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
S
O
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
OH
O
HO
443.
ERLOTINIB
HYDROCHLORIDE
ERLOTINIB
Impurity
6,7-Bis(2-Methoxyethoxy)-N-
(3-ethylphenyl)quinazolin-4-
amine.
N
N
HN
O
O
O
O

444.
ERLOTINIB
HYDROCHLORIDE
ERLOTINIB
Impurity
6,7-Bis(2-Methoxyethoxy)-N-
(3-ethylphenyl)-N-(2-
methoxyethyl)quinazolin-4-
amine
N
N
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
N
OH
F
N
450. Escitalopram
Escitalopram
Related
Compound A
((-) 4-[(4-dimethylamino)-1-(4-
fluorophenyl)-1-
(hydroxybutyl)]-3-
(hydroxymethyl) benzonitrile)
NHO
F
N
OH

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
O
HO
OH

459.
Ethyl
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
O
HO
OH
463.
Ethyl
Hydroxybenzoate
Sodium
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)
N
H
HO
OH
467.
Etilefrine
Hydrochloride
EP Impurity E
1-(3-hydroxyphenyl)ethanone
(3-hydroxyacetophenone)

468.
Etilefrine
Hydrochloride
EP Impurity F
N-benzylethanamine
(benzylethylamine).
H
N
469. Etofenamate EP Impurity A flufenamic acid
470. Etofenamate EP Impurity C
N-phenyl-3-
(trifluoromethyl)aniline N
HF
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

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
N
O
HO
HO
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

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-
488. Ezetimibe
SSR Isomer of
Ezetimibe
SSR Isomer of Ezetimibe

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
[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
H
N
OH
F
F
OH
493. Ezetimibe (3’R)-Ezetimibe
impurity
[(3R)-3-(4-fluorophenyl)-3-
hydroxypropyl]-4-(4-
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
NN
H
N
O
OH
OH
H2N

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
O
O
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
S
S
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
S
S
N N
NH2
NH2

503. Famotidine EP Impurity E
2,2’-
[disulphanediylbis(methylenet
hiazole-4,2-diyl)]diguanidine
504. Famotidine EP Impurity D
3-[[[2-
[(diaminomethylene)amino]
thiazol-4-yl]methyl]sulphanyl]
propanamide
O
H2N
S
S
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 S
S
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
H2N
O
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-
dicarboxylate
NH
O O
O
O
Cl
Cl

512. Felodipine EP Impurity C
diethyl 4-(2,3-dichlorophenyl)-
2,6-dimethyl-1,4-
dihydropyridine-3,5-
dicarboxylate
NH
O O
O
O
Cl
Cl
513. Fenbendazole
Fenbendazole
Related
Compound A
Methyl (1H-benzimidazole-2-
yl)carbamate
NH
O
O
N
N
H
514. Fenbufen EP Impurity C biphenyl
515. Fenofibrate EP Impurity A
(4-chlorophenyl)(4-
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-
methylpropanoate
O
O
O
O
Cl
519. Fenofibrate EP Impurity F
(4-chlorophenyl)[4-(1-
methylethoxy)phenyl]methan
one
O
OCl

520. Fenofibrate EP Impurity D
methyl 2-[4-(4-
methylpropanoate O
O
O
O
Cl
521. Fenofibrate
Fenofibrate
Related
Compound A
(4-chlorophenyl)(4-
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

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
phenypropyl-4-
(methylphenyl)isobutyrate
O
O
N
532. FESOTERODINE
FESOTERODINE
Impurity
phenypropyl)phenyl
isobutyrate
O
O
N
533. FESOTERODINE
FESOTERODINE
Impurity
(R)-3-(3-Diisopropylamino)-1-
phenylpropyl)-4-
(isobutyryloxy)benzylisobutyra
te
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

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
N
H
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)piper
idin-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
HN
O
H
H
H
H

541. FINASTERIDE
Finasteride
Impurity
(5alpha,17beta)-N-
(cyclohexyl)-3-oxo-4-aza-5-
androst-1-ene-17-
carboxamide
HN O
HN
O
H
H
H
H
542. FINASTERIDE EP Impurity B
(5alpha,17beta)-Methyl 3-oxo-
4-aza-5-androst-1-ene-17-
carboxylate
HN O
O
O
H
H
H
H
543. FINASTERIDE
Finasteride
Impurity
1,3-Dicyclohexyl urea
N
H
O
N
H
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
N
N
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
N
N
N
N
N
N
F
F
547. Fluconazole EP Impurity C
1,1’-(1,3-phenylene)di-1H-
1,2,4-triazole N
N
N
N
N
N
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
N
N
N
N
N
F

549. Flumazenil
Flumazenil
Related
Compound C
N,N-Dimethylformamide
diethyl acetal
N
OO
550. Flunarizine EP Impurity A
1-[bis(4-
fluorophenyl)methyl]piperazin
e
NHN
F
F
551. Flunarizine EP Impurity B
1-[(RS)-(4-
fluorophenyl)phenylmethyl]-
4-[(2E)-3-phenylprop-2-
enyl]piperazine
N
N
F
552. Flunarizine EP Impurity C
1-[(RS)-(2-fluorophenyl)(4-
fluorophenyl)methyl]-4-[(2E)-
3-phenylprop-2-
enyl]piperazine
N
N
F
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
HO
HOHO
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
O
HOHO
N
F
(E)

557.
FROVATRIPTAN
SUCCINATE
FROVATRIPTAN
S-Isomer
(3S)-2,3,4,9-Tetrahydro-3-
(methylamiano)-1H-carbazole-
6-carboxamide(ent-
Frovatriptan)
N
H
(S)
O
NH2
H
N
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
O
O
O
O
S
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)met
hyl)-1,2-dihydro-1,2,4-triazol-
3-one
NHHN
N
ON
O
F
O
F
F
F
F
F
F
561.
Fosaprepitant
dimeglumine
Fosaprepitant
Impurity
Benzyl hydrogen3-(((2R,3S)-
2((R)-1-(3,5-
bis(trifluoromethyl)phenyl)eth
oxy)-3-(4-fluorophenyl)-4-
morpholino)methyl)-5-oxo-
4,5-dihydro-1H-1,2,4-triazol-1-
ylphosphonate
NN
H
N
P
O
OH
O
O
O
N
F
O
F
F
F
F
F
F
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
O
HOHO
N
F

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
N
H
N
HN
O
H2N
566. GANCICLOVIR
GANCICLOVIR
Impurity
2-Amino-7-[[2-hydroxy-1-
(hydroxymethyl)ethoxy]methy
l]-1,7-dihydro-6H-Purin-6-one
N
N
N
H
N
O
O
HO
OH
H2N
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

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
HN
S
O
O
NH2
O
Cl
576. Glibenclamide EP Impurity B
(methyl-[[4-[2-[(5-chloro-2-
methoxybenzoyl)-
amino]ethyl]phenyl]sulfonyl]c
arbamate)
NH
O
O
S
O
O
HN
O
O
Cl
577. Glibenclamide EP Impurity C Glibenclamide Impurity C
H
N
O
H
NS
O
O
N
H
N
H
O

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
N
H
O
S
O
O H
N
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
H
N
O
H
NS
O
O
N
H
O
N
O
583. Glipizide
EP Impurity A
5-methyl-N-[2-(4-
sulphamoylphenyl)ethyl]pyraz
ine-2-carboxamide
N
N
ON
H
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
HN
S
O
O
NH2
O
Cl

586. Glyburide
Glyburide
Related
Compound B
(methyl-[[4-[2-[(5-chloro-2-
methoxybenzoyl)-
amino]ethyl]phenyl]sulfonyl]c
arbamate)
NH
O
O
S
O
O
HN
O
O
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
N
N
O
OH
591.
Granisetron
Hydrochloride
EP Impurity H 1H-indazole-3-carboxylic acid
H
N
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

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

604. Hydrochlorothiazide EP Impurity A chlorothiazide
605. Hydrochlorothiazide EP Impurity B
4-amino-6-chlorobenzene-1,3-
disulphonamide (salamide), S
O
O
NH2
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-
perazine
NHN
Cl
609.
Hydroxyzine
Hydrochloride
EP Impurity B
2-[2-[4-
(diphenylmethyl)piperazin-1-
yl]ethoxy]ethanol
(decloxizine) O
N
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]ethanon
e
O

613. Ifosfamide EP Impurity C 2-chloroethanamine H2N
Cl
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
S
O
O
HO
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 N
N
O
619. Indometacin EP Impurity A 4-chlorobenzoic acid
O
HO
Cl

620.
Indoramin
Hydrochloride
EP Impurity A 3-(2-bromoethyl)indole
H
N
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
N
H
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
N
H
HN
N N
N
NH
O
627. Irbesartan
Irbesartan
Impurity
4-Bromomethyl-2'-
cyanobipheny
CNBr

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
N
N
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
N N
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
OH
HO
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
N
O
O
O
OH
HO

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
N
N
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-
1,2,4-triazol-3-one
N
N
N
O
N N O O
O
N
N
N
Cl
Cl
636. ITRACONAZOLE
EP Impurity C
4-[4-[4-[4-[[cis-2-(2,4-
dioxolan-4-yl]
yl]phenyl]-2-propyl-2,4-
dihydro-3H-1,2,4-triazol-3-one
N
N N
O N
N
O
O
O
N
NN
ClCl
637. ITRACONAZOLE
EP Impurity D
4-[4-[4-[4-[[cis-2-(2,4-
dioxolan-4-yl]
yl]phenyl]-2-(1-methylethyl)-
2,4-dihydro-3H-1,2,4-triazol-3-
one
N
N N
O N
N
O
O
O
N
NN
ClCl

638. ITRACONAZOLE
EP Impurity E
4-[4-[4-[4-[[trans-2-(2,4-
dioxolan-4-yl]
1,2,4-
triazol- 3-one
N
N N
O N
N
O
O
O
N
NN
ClCl
639. ITRACONAZOLE
EP Impurity F
2-butyl-4-[4-[4-[4-[[cis-2-(2,4-
dioxolan-
4-
yl]methoxy]phenyl]piperazin-
1-yl]phenyl]-2,4-dihydro-3H-
1,2,4-triazol-3-one
N
N N
O
N N
O O
O
N
NN
Cl
Cl
640. ITRACONAZOLE
EP Impurity G
4-[4-[4-[4-[[cis-2-(2,4-
dioxolan-4-yl]
yl]phenyl]-2-[[cis-2-(2,4-
triazol-1-
ylmethyl)-1,3-dioxolan-4-
yl]methyl]-2,4-dihydro-3H-
1,2,4-triazol-3-one
N
N
N
O
O
O
N
N
N
Cl
Cl
NN
OO
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

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
HO
NH2
O
646. Lansoprazole EP Impurity E 1H-benzimidazole-2-thiol
N
H
N
HS
647. Lansoprazole EP Impurity B
2-[[[3-methyl-4-(2,2,2-
trifluoroethoxy)pyridin-2-
yl]methyl]sulphonyl]-
1Hbenzimidazole
N
N
H
S
O
O N
O
F
F
F
648. Lansoprazole EP Impurity D 1H-benzimidazol-2-ol
N
H
N
HO
649. Lansoprazole EP Impurity E 1H-benzimidazole-2-thiol
N
H
N
HS

650. Lansoprazole EP Impurity C
2-[[[3-methyl-4-(2,2,2-
trifluoroethoxy)pyridin-2-
yl]methyl]sulphanyl]-
1Hbenzimidazole
N
N
H
S
N
O
F
F
F
651. Lansoprazole EP Impurity F
2-[(RS)-[(4-chloro-3-
methylpyridin-2-
yl)methyl]sulphinyl]-1H-
benzimidazole
N
N
H
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
N
H
S
O N
O
F
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

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
N
S
O
OO
N
N
HN
O
F
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
H
N
F
F
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

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
O
OH
N+O
O-
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

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
OH
HO
HO OH
NH2
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

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-
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-
carboxylic acid
N
O
O
OH
N
HN
O
F

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-
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-
carboxylic acid
O
N
O
HO
O
F
F
689.
Levomepromazine
Maleate
EP Impurity A 2-methoxyphenothiazine
S
N
H
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)

693. Lidocaine EP Impurity G
N-(2,6-dimethylphenyl)-2-((1-
methylethyl)amino)
acetamide
O
N
H
H
N
694. Lidocaine EP Impurity H
2-chloro-N-(2,6-
O
NH Cl
695. Lidocaine EP Impurity C
N-(2,6-
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)
O
N
H
(R)
O OH
H2N
Lisinopril
Impurity
Trifluoro acetyl L-lysine
N
H2N
O OH
O
F
F
F

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
N
H
O
N
H
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

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
S
N
S
O
O O
O
Cl O
713. Loratadine EP Impurity B
8-chloro-5,6-dihydro-11H-
b]pyridin-11-one
N
O
Cl
714. Loratadine EP Impurity D
8-chloro-11-(piperidin-4-
ylidene)-6,11-dihydro-5H-
b]pyridine
N
H
N
Cl
715. Loratadine EP Impurity G
8-chloro-11-(1-
methylpiperidin-4-ylidene)-
6,11-dihydro-5H-
b]pyridine
N
N
Cl

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
Bromodeslorat
adine impurity
Bromodesloratadine impurity
N
H
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
H
N
Cl
721. Loratadine
Lorazepam
Related
Compound B
2-Amino-2',5-
dichlorobenzophenone
O
Cl
Cl
NH2

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
N
NH
NN
N
Cl
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),

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-
(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)
N
N
N
N
F
F
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)
N
N
N
N
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)
N
N
N
N
F
F
H

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
F
F
N
N
N
N
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

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
O
NH2
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

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 H
N
N
N
O
754. Metamizole EP Impurity B
4-amino-1,2-dihydro-2,3-
dimethyl-1-phenylpyrazol-5-
one
N
N
O
H2N
755. Metamizole EP Impurity C
1,2-dihydro-2,3-dimethyl-4-
(methylamino)-1-
phenylpyrazol-5-one
N
N
OH
N
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
N
H
NH2
NH
N

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
H
N
762.
Metformin
Hydrochloride
Metformin
Related
Compound A
1-Cyanoguanidine
N
H
NH2
NH
N
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]b
enzaldehyde
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-
n-2-ol]
N
OH
O
O
OH
O
O

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-
ne-1,2-diol
HO
OH
O
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)

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)methy
l)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)c
yclopropyl)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)
2-(1-((((R) -1-(3-(2-(7-
Chloroquinolin-2-
yl)ethyl)phenyl)-3-(2-(2-
hydroxypropan-2-
yl)phenyl)propyl)Sulfonyl)met
hyl)cyclopropyl)acetic acid
OHO
S
O
O
HO
N
Cl
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

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-
acid
N O
OH
O
H
N
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-
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-
acid
N
O
HO
O
HN
N
OH
F
H
H

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
O
N
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-
methylhex-4-enoate N-oxide
C
H•
O
OO
O
O
OH
N+
OO-
791. Mycophenolate EP Impurity F
(4E)-6-(4-hydroxy-6-methoxy-
7-methyl-3-oxo1,3-
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

796.
Naratriptan
Hydrochloride
NARATRIPTAN
Related
Compound A
3-(1-Methylpiperidin-4-yl)-1H-
Indole
HN
N
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 N
H
N
S
O
O
NH
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]

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
H
N
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
N
N
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
N
H 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
OH
O
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

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
H
N 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)methanesulph
onamide
S
O
O
NH
O
N+
O
-
O
N+
O
-
O
820. Nimesulide EP Impurity B
N-(2-
phenoxyphenyl)methanesulph
onamide,
S
O
O
HNO
821. Nimesulide EP Impurity E
N,N-bis(methylsulphonyl)-2-
phenoxyaniline, NO S
O
O
S
O
O
822. Nimesulide EP Impurity F
N,N-bis(methylsulphonyl)-4-
nitro-2-phenoxyaniline
N
O
N+
O
O-
S
O
O
SO O

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