Sl. No. API IMPURITY CHEMICAL NAME...

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


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


EP Impurity B 2-chloro-6,7-

dimethoxyquinazolin-4-amine

N

N

NH2

O

O

Cl


EP Impurity D

N-(4-Amino-6,7-dimethoxyquinozolin-2yl)-N-methylpropane-1,3-diamine

hydrochloride

N

H2N

N

N

O

O

NH2


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


Related Compound B

5-(formylamino)-1H-pyrazole-4-carboxamide NH

NO

H2N

HN

O


Related Compound C

5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide

NH

NO

H2N

NN

N


Related Compound D

ethyl 5-amino-1H-pyrazole-4-carboxylate NH

N

O

O

NH2


Related Compound E

ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate

HNN

O

ONHO


Related Compound F

(ethyl-(E/Z)-3-(2-carbethoxy-2-cyanoethenyl)amino-1H-pyrazole-4-carboxylate)

HN N

OO

NH

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

OHNH

(R)

O

N

(R)(R)

HO

30. ALVIMOPAN ALVIMOPAN

Impurity 1-hydroxy benzo triazole N

NN

OH


Impurity

(2S,3R,4R)-4-(3-Hydroxyphenyl)-3,4-dimethyl-

alpha-(phenylmethyl)-1-piperidine propanoic

acid(Alvimopan Metabolite)

NO

OH

HO


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


34. Amiodarone Hydrochloride

Amiodarone Related

Compound D

((2-butylbenzofuran-3-yl)(4-hydroxy-3,5-

diiodophenyl)methanone) O I

I

OHO


Amiodarone Related

Compound E

((2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone)

O

OHO


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


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-


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-


dicarboxylate benzenesulphonate

HN

O

O

O

O

Cl

O

NH2


45. Amlodipine EP Impurity I

3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(4-


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


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



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


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)


Related Compound B


Related Compound C

(1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-carbonitrile)

HN

NN

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

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


65. Aripiprazole

USP

Aripiprazole

quinoline

impurity

7-Hydroxy-3,4-dihydroquinolin-2(1H)-one N

HO OH


Related Compound C

(1- (2,3-Dichlorophenyl)

piperazine HCl) NHN

ClCl


Dehydro impurity

7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-2(1H)-

quinolinone

HN

O

O

N

N

Cl

Cl


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


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


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


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


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


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


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


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



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


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


Related Compound D

(Epoxide impurity, or 3-(4-Fluorobenzoyl)-2-isobutyryl-3-

phenyl-oxirane-2-carboxylic acid phenylamide)

O

O

HN

OO

F


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


110. Atovaquone Atovaquone

Related Compound A

(cis-2-[4-(4-chlorophenyl)cyclohexyl]-3-

hydroxy-1,4-naphthoquinone)

O

O

HO

Cl


Related Compound

4-(4-Chlorophenyl)-cyclohexane carboxylic acid

Cl

O

OH


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


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)


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


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


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


149. Bicalutamide EP Impurity D 4-Amino -2-(trifluoromethyl) benzonitrile

N

F

F

F

H2N

150. Bicalutamide EP Impurity


fluorophenyl)sulfinyl]-2-hydroxy-2-methyl-

propanamide

O

HN

OH

SO

FF

FF

N



fluorophenyl)sulfinyl]-2-Acetyloxy-2-methyl-

propanamide

O

HN

O

O

SO

F

F

FF

N


2,3-Epoxy-2-mehyl-N-[4-Cyano-3-

(trifluoromethyl)phenyl]propanamide

O

HN

FF

F

N

O


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


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


Impurity N-(Pyrazine-2-ylcarbonyl)-L-

Phenylalanine

HN

OHOO

N

N


Impurity

[(1(R)-3-methyl-1-[[(2R)-1-oxo-3-phenyl-2-

[(pyrazinylcarbonyl)amino]propyl]

amino]butyl] boronicacid N

NNH

OHN

O

BOH

OH


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



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


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


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


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


EP Impurity B 4-chlorobenzhydrol, 1-(4-

chlorobenzhydryl)piperazine N

NH

Cl



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


EP Impurity B methyl 4-hydroxybenzoate

O

O

HO


EP Impurity C ethyl 4-hydroxybenzoate

O

O

HO



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


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


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


EP Impurity C


ethyl 3-[[2′ -(1-ethyl-1H-tetrazol-5-yl)biphenyl-4-

yl]methyl]-2-oxo-2,3-dihydro-1H-benzimidazole-4-

carboxylate


EP Impurity D


ethyl 3-[[2′ -(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-

yl]methyl]-2-oxo-2,3-dihydro-1H-benzimidazole-4-

carboxylate


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



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


EP Impurity G

2-ethoxy-1-[[2′ -(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-

benzimidazole-7-carboxylic acid (candesartan)


EP Impurity H


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)


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


Impurity

5'-Deoxy-5-fluoro-N4-(2-methyl-1-

butyloxycarbonyl)cytidine

O

HOOH

NHN

F

O O

O


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


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



Related Compound D

(4-(Oxiran-2-ylmethoxy)-9H-carbazole)

NH

O

O


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

HN

OOHO


Impurity 7-Amino-3-(Z-propen-1-yl)-3-

cephem-4-carboxylic acid

SH2N

O

OHO

CH3

HH


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


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


METABOLITE

4-[2-hydroxy-5-(4'Methylphenyl)-3-(tri

fluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide

S

O

ONH2

NN

F

F

FHO


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


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


EP Impurity B N-(pyridin-2-yl)pyridin-2-

amine (2,2¢-dipyridylamine)

N

NH

N


EP Impurity C 3-(4-chlorophenyl)-N-methyl-

3-(pyridin-2-yl)propan-1-amine HN

N

Cl


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


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


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


265. Citalopram Citalopram

Related compound A

1-(3-(dimethylamino)propyl)-1-(4'-fluorophenyl)-1,3-

dihydroisobenzofuran-5-carboxamide

O

O

NH2

F

N


Related compound D

1-(4'-fluorophenyl)-1-(3-(methylamino)propyl)-1,3-dihydroisobenzofuran-5-

carbonitrile

O

N

HN

F


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


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


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


Related compound B

Methyl (+/-)-(o-Chlorophenyl)-4,5-dihydrothieno[3,2-

c]pyridine-6(7H)acetateHydrochloride

N S

O

HO

Cl

H

Cl


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


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


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


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



e Impurity


pyridinyl]methyl]thio]-1H-benzimidazole( Sulfide

impurity)

N

NH

S

N

OF

FF


e Impurity


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


e Impurity B

N-[(6R)-2-Amino-4,5,6,7-terthydro-1,3-benxothiazol-6-

yl]propanamide S

N

(R) NH2

NH

O


e Impurity C

(S)-4,5,6,7-terahydro-N-6-propyl-2,6-

benzothiazolediamine S

N

(S) NH2

NH


e Impurity

(6R)-6-N-ethyl-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-

2,6-diamine( Ethyl Dexpramipexole)

S

N

(R) NH2

NH


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


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


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


Related Compound A

Hypoxanthine HN

NN

N

OH


Related Compound B

2',3'-dideoxyadenosine HO

O

NN

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


EP Impurity E diphenylmethanone

(benzophenone). O


EP Impurity A 2-(diphenylmethoxy)-N-

methylethanamine NH

O


EP Impurity D diphenylmethanol

(benzhydrol), OH


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


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


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


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


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]


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]


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]


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

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


1-Benzyl-4-[(5,6-dimethoxy-1H-inden-

2yl)methyl]piperidine

N O

O


5,6-Dimethoxy-2-(4-pyridyl)methyl-indan-1-one

O

N

O

O



2,3-Dihydro-5,6-dimethoxy-2-[(4-pyridinyl)methylene-1H-

inden-1-one O

O

O


1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-indan-2yl)methyl]piperidine

N O

O


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


N-Desbutyl Impurity

N-[2-Butyl-3-[4-[3-(butylamino)propoxy]benzoyl]

-5-benzofuranyl]methanesulfona

mide 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)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


DORIPENEM Impurity

4-Nitrobenzyl(2S,4S)-2-{[aminosulfonyl)amino]methyl

]-4-mercaptopyrrolidine-1-carboxylate

N

O

O

SH

HN

SO

OH2N N+O

O-


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


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


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


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

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


Related Compound C

2-chloro-4-amino-6,7-dimethoxyquinazoline

N

N

O

O

NH2

Cl


Related Compound D

1,4-benzodioxane-2-carboxylic acid

O

OO

HO


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


EP Impurity B (1RS)-1-phenyl-1-(pyridin-2-

yl)ethanol N

HO



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


EP Impurity (R,S)-N-Methyl-3-(1-Naphthyloxy)-3-(3-

thienyl)propanamine HN

SO


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


Compound B

4-(hydroxymethyl)benzoic acid

O

HO

OH


Compound C terephthalic acid

O

HO O

OH



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


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


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


(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


(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


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


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


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


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


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



ERLOTINIB Impurity

6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)-N-(2-

methoxyethyl)quinazolin-4-amine

NN

N

O

O

O

OO


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


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



HO

OH




O

O

HO


EP Impurity C propyl 4-hydroxybenzoate

O

O

HO


EP Impurity D butyl 4-hydroxybenzoate O

O

OH

462. Ethyl Hydroxybenzoate Sodium


HO

OH



O

O

HO


EP Impurity C propyl 4-hydroxybenzoate

O

O

HO


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


EP Impurity E 1-(3-hydroxyphenyl)ethanone

(3-hydroxyacetophenone)



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


Impurity

4-(6-Amino-5-bromo-2-[(4-cyanophenyl)amino]pyrimidin-

4-yloxy) 3,5-dimethyl benzamide

O

NH2

O

N

N

NHN

BrH2N


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

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


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


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


496. FAMCICLOVIR FAMCICLOVIR

Impurity

2-[2-(2-Amino-9H-purin-9-yl)ethyl]-propane-1,3-diol

hydrochloride OH

OH

N

NN

N

H2N


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


Impurity 4-(2-Amino-9H-Purin-9-yl)-2-

(hydroxyl methyl)butyl acetate

O

OOH

N

NN

N

H2N


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


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-


NH

O O

O

O

ClCl


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


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


529. FESOTERODINE FESOTERODINE

Impurity A

2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-

(hydroxymethyl) phenol HO

OH

N


Impurity (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-methylphenol

N

OH


Impurity

2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-

(methylphenyl)isobutyrate

O

O

N


Impurity

2-((R)-3-(Diisoprpylamino)-1-phenypropyl)phenyl

isobutyrate O

O

N


Impurity

(R)-3-(3-Diisopropylamino)-1-phenylpropyl)-4-

(isobutyryloxy)benzylisobutyrate

O

O

O

N

O


Impurity

Isobutyic acid2-((S)-3-diisopropylammonium-1-

phenylpropyl)-4-hydroxymethyl)phenyl

ester(S-ISOMER) O

O

OH

(S)

N



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


Fexofenadine Related

Compound A

(4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-

piperidinyl]butyl]-alpha,alpha-dimethyl benzeneacetic acid)

O

HO

N

OH

O



Compound B

2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piper

idin-1-yl]butyl]phenyl]-2-methylpropanoic acid

O

OH

N

OH

OH



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


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


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)


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)


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


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


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


3-chloro-4-fluoro aniline NH2

F

Cl


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

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


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


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


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


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


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



2-formylbenzoic acid O

HO

O



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

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


EP Impurity B

2-[2-[4-(diphenylmethyl)piperazin-1-

yl]ethoxy]ethanol (decloxizine)

ON

N

OH


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


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


IMATINIB Impurity

N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]-

amino]phenyl]4-methylbenzamide methanusulfonate

O

NH

NH

N

N

N

SO

OHO


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


620. Indoramin Hydrochloride

EP Impurity A 3-(2-bromoethyl)indole

HN

Br


EP Impurity B N-(1-benzyl-4-

piperidyl)benzamide ON

H

N


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



triphenyl methane


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


triphenyl methanol OH


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


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



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



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


638. ITRACONAZOLE EP Impurity E

4-[4-[4-[4-[[trans-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-


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



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


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


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


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


Related Compound B

2-Cyano-3-hydroxy-N-(4'-trifluoromethylphenyl)-

crotone amide


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


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


671. Levetiracetam Levetiracetam

Related Compound B

(S)-2-aminobutanamide hydrochloride

O

H2N

H2N

H Cl


R-ISOMER

(alpha R)- alpha-Ethyl-2-oxo-1-pyrrolidine acetamide( R-

ISOMER) N(R)

O

H2N

O


Impurity (R)-(+)-alpha-Methyl-benzyl

amine H2N

(R)


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


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


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)


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


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


EP Impurity D iminodibenzyl


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


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


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


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


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


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),


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


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



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


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


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


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


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)


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)


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


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-


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-


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-


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

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


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


Related Compound B

N-(trans-4-isopropylcyclohexanecarbonyl

)-L-phenylalanine

HN

O

OH

O


Related Compound C

N-(cis-4-isopropylcyclohexylcarbonyl)-

D-Phenylalanene

HN

O

OH

O


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

HN

N

Cl


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


Impurity

2-((2'-Cyclopropylamino)-3'-pyridyl)-7-methyloxazolo[5,4-

B]-pyridine NO

NN

NH


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


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


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


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


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


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


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


Impurity

Ethyl(3R,4R,5S)-4-(Acetylamino)-5-azido-3-

(ethylpropoxy)-1-cyclohexene-1-carboxylate O

OO

NN+N-

HNO


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


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



(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


(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


(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


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


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


d]pyrimidin-5-yl)ethyl]benzoicacid

HO

ONH

N

NH

O NH2

877. PEMETREXED Pemetrexed

Impurity


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


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


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


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-


SN

O

O

OH

O

O

905. Piroxicam EPImpurity K

ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-


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


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


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


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


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


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


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


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


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


EP Impurity K N-methyl-1-methylthio-2-

nitroethenamine HN

N+ O

-O

S


EP Impurity B

2-[[[5-[(dimethylamino)methyl]furan

-2-yl]methyl]sulphanyl]ethanami

ne

NH2S

O

N


EP Impurity C

N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphinyl]ethyl]-

N¢-methyl-2- nitroethene-1,1-diamine


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

.


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


(2E)-3-(4-Amino-3,5-dimethylphenyl) acrylonitrile

N

H2N



4-[(4-Chloro-2-pyrimidinyl)amino]benzonitril

e

N

NH

N

N

Cl


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


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


Des Chloro Impurity

N-Piperidino-1-(2,4-dichlorophenyl)-5-phenyl-4-

methyl-pyrazole-3-carboxamide(Des chloro

impurity)

NN

O

NH

ClCl

N


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


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


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


Related Compound C

((S)-3-[1-(Dimethylamino)ethyl]phenol)

N

HO


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


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


Impurity 3-(Cyclopropylmethoxy)-4-

(difluoromethoxy)benzoicacid

O

OH

O

FF

O


Impurity

N-(3,5-Dichloropropyridin-4-yl)-3,4-

bis(difluoromethoxy)benzamide

O

NH

O

F

F

N

Cl

Cl

O

F

F


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


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


EP Impurity C

(-)-(2S)-N-(2,6-dimethylphenyl)-1-methylpiperidine-2-

carboxamide ((S)-mepivacaine),

N

O

HN


EP Impurity G

(+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-

ropivacaine),

N O

HN


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


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


EP Impurity C

(1RS,4RS)-4-(4-chlorophenyl)-N-methyl-1,2,3,4-

tetrahydronaphthalen-1-amine

NHCl



EP Impurity E (2R)-hydroxyphenylacetic acid

((R)-mandelic acid)


EP Impurity F (4R)-4-(3,4-dichlorophenyl)-

3,4-dihydronaphthalen-1(2H)-one


SERTRALINE Oxime Impurity

(+/-)-4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-

napthalenone.oxime

NHO

Cl

Cl


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


Related Compound B

1-(1-(3-chlorophenyl)cyclobutyl)-N,N,3-trimethylbutan-1-

amine.Hcl

N

Cl

H

Cl


Related Compound C

1-(1-(4-chlorophenyl)cyclobutyl)-N,N-dimethylpentan-1-amine.Hcl

N

Cl

HCl



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


Impurity

4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-

carboxamide

N

N

O NH2

O

HN

O


Impurity 2-Ethoxy benzoic acid

O

HO

O



O

OHO




O

OH

O


Impurity

4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-

carboxamide

N

N

O NH2

O

HN

O


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


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


Impurity

1-Methyl-4-nitro-3-propyl-1H-pyrazole-5-

carboxamide(Sildenafil amide) NN

O

NH2

N+O-O


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


(R)-3-(5-(2-Aminopropyl)-7-cyanoindolin-1-yl)propyl

benzoate tartate O

O

OH

HOO

OH

O

HO

N

N

H2N



(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-


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]-


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-


(2S)-2- methylbutanoate (lovastatin),


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


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


EP Impurity B N-(4-

sulphamoylphenyl)acetamide

O

NHS

O

O

H2N


EP Impurity C N-[[4-

(acetylamino)phenyl]sulphonyl]acetamide

O

NH

S

O

O

HN

O


EP Impurity D dapsone.

1060. Sulfaguanidine EP Impurity A 4-

aminobenzenesulphonamide (sulphanilamide)

S

O

O

NH2H2N


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


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


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


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


Impurity

5-Amino-1-(N-Methyl carbamoyl)imidazole-4-

carboxamide

N

N

O

NH2

HN

O

NH2


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



Tenofovir Related

Compound B

((E)-9-(Prop-1-enyl)-9H-purin-6-amine) N

N

NH2

N

N


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


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


EP Impurity K prazosin


EP Impurity L 1-(furan-2-

ylcarbonyl)piperazine N

HN

O

O



EP Impurity M 1,4-bis(furan-2-

ylcarbonyl)piperazine N

N

O

O

O

O


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


EP Impurity B

(2Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-

2-en-4-yn-1-amine (cis-terbinafine)


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


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


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


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



Impurity

4-[(5-Hydroxy-2,3,4,5-tetrahydro-1H-1-benzazepine-

1-yl)carbonyl]-3-methylphenyl-2-

methylvenzamide

O

NH

O

N

OH


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


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



Impurity

(2S,3aR,7aS)-benzyl octahydro-1H-indole-2-

carboxylate

HN

O

O

H

H


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


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


EP Impurity C 2,3,4-trimethoxybenzaldehyde

O

O

OO


EP Impurity D (2,3,4-

trimethoxyphenyl)methanol HO

O

OO


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


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


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


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


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


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


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



impurity

(S)-methyl-2-(N-((2’-Cyano biphenyl -4- yl)methyl)

pentanamido)-3- methylbutanoate

N

O

OCN

O


impurity

S)-2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl

amino)-3-methylbutanoic acid

NH

O

HO NH

NN

N


impurity

(S)-methyl 2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl

amino)-3-methylbutanoate

NH

O

O NH

NN

N


impurity

(S)-methyl 2-(N-((2’-(1H-tetrazole-5-yl)biphenyl-4-

yl)methyl)pentanomido)-3-methylbutanoate

N

O

O

O

NH

NN

N


impurity

(S)-2-[N-((2’-cyanobiphenyl-4-yl)Methyl)pentanamido]-3-

Methyl butanoic acid

N

O

HOCN

O


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


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


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


Related Compound C

thymine NH

ONH

O


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


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


Date post:	30-Jan-2020
Category:	Documents
Upload:	others
View:	8 times
Download:	0 times

Sl. No. API IMPURITY CHEMICAL NAME...

Documents