Page 1 of 45

Amorolfine HCl EP-Impurities:-

Impurity-A:-

CAS No: -78613-39-5

Chemical name: -(2RS, 6SR)-4-[(2RS)-3-[4-(1, 1-dimethylpropyl) phenyl]-2-methylpropyl]-2,6-

dimethyl morpholine-4-oxide.

Structure:-

NCH3O

CH3

H3C

CH3CH3H3C

H

H

H

O

M.F: C21H35NO2Mol. Wt.: 333.51

Impurity-B:-

CAS No:-142347-84-0

Chemical name: -Mixture of N-[(2R)-3-[4-(1,1-dimethylpropyl)-phenyl]-2-methylpropyl]-N-[(2RS)-

(2-methylperoxy)propyl]formamide and N-[(2S)-3-[4-(1,1-dimethylpropyl)-phenyl]-2-methyl

propyl]-N-[(2RS)-(2-methylperoxy)propyl]formamide.

Structure:-

NCH3O OHC

H3C

CH3CH3H3C

H

HH3CO

M.F: C20H33NO3Mol. Wt.: 335.48

Impurity-C:-

CAS No:-78613-37-3

Chemical name:- (2RS, 6SR)-4-[(2RS)-2-methyl-3-phenylpropyl]-2,6-dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

H

M.F: C16H25NO

Mol. Wt.: 247.38

Page 2 of 45

Impurity-D:-

CAS No:-

Chemical name:- (2RS, 6SR)-4-[(2RS)-3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropyl]-2,6-

dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

H CH3

H3CCH3

M.F: C20H33NO

Mol. Wt.: 303.48

Impurity-E:-

CAS No:-78613-38-4

Chemical name:- Mixture of (2RS, 6RS)-4-[(2R)-3-[4-(1,1-dimethylpropyl)phenyl]-2-methylpropyl]

-2,6-dimethyl morpholine and (2RS, 6RS)-4-[(2S)- 3-[4-(1,1-dimethylpropyl)phenyl]-2-methyl

propyl]-2,6-dimethyl morpholine.

Structure:-

NCH3O

CH3

H3CH

H

H

H3CCH3

CH3

MF: C21H35NO

Mol. Wt.: 317.51

Impurity-F:-

CAS No:-

Chemical name: -1-[4-(1, 1-dimethylpropyl) phenyl] propan-1-one.

Structure:-

H3C

H3CCH3

CH3

O

M.F: C14H20O

Mol. Wt.: 204.31

Page 3 of 45

Impurity-G:-

CAS No:-

Chemical name: - (2RS)-3-[(2RS, 6SR)-2, 6-dimethylmorpholin-4-yl]-1-[4-(1,1-dimethylpropyl)

phenyl]-2-methylpropan-1-one.

Structure:-

NCH3O

CH3

H3CH

H

H

H3CCH3

CH3

O

M.F: C21H33NO2Mol. Wt.: 331.49

Impurity-H:-

CAS No:-

Chemical name: 2-[(2RS)-3-[(2RS, 6SR)-2,6-dimethylmorpholin-4-yl]-2-methylpropyl]-5-(1,1-

dimethylpropyl)phenol.

Structure:-

NCH3O

CH3

H3CH

H

H

H3CCH3

CH3

OH

M.F: C21H35NO2Mol. Wt.: 333.51

Impurity-I:-

CAS No:-67468-13-7

Chemical name: (2RS, 6SR)-4-[(2RS)-3-[4-(1,2-dimethylpropyl)phenyl]-2-methylpropyl]-2,6-

dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

H

M.F: C21H35NO

Mol. Wt.: 317.51

CH3

CH3

CH3

Page 4 of 45

Impurity-J:-

CAS No:-

Chemical name: (2RS, 6SR)-4-[(2RS)-3-[3-(1,1-dimethylpropyl)phenyl]-2-methylpropyl]-2,6-

dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

H

CH3

CH3H3C

M.F: C21H35NO

Mol. Wt.: 317.51

Impurity-K:-

CAS No:-

Chemical name: (2RS, 6SR)-4-[(2RS)-3-[4-(1-ethyl-1-methylpropyl)phenyl]-2-methylpropyl]-2,6-

dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

HCH3

CH3

H3C

M.F: C22H37NO

Mol. Wt.: 331.54

Impurity-L:-

CAS No:-

Chemical name: (2RS, 6SR)-4-[(2RS)-3-[3,5-bis(1,1-dimethylpropyl) phenyl]-2-methylpropyl]-2,6-

dimethylmorpholine.

Structure:-

NCH3O

CH3

H3CH

H

H

H3C CH3CH3

H3C

H3C

CH3M.F: C26H45NO

Mol. Wt.: 387.64

Page 5 of 45

Dabigatran impurities:

Dabigatran impurity

CAS No. 1408238-40-3

Chemical Name: 3-({2-[(4-Hexyloxycarbonylaminocarbonyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid ethyl ester Structure:

Dabigatran impurity

CAS No. 1408238-37-8 Chemical Name: 3-({2-[(4-Hexyloxycarbonylaminocarbonyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid Structure:

Molecular Formula: C34H40N6O6

Molecular Weight: 628.72

Page 6 of 45

Dabigatran impurity: CAS No. 211914-51-1 Chemical name: 3-({2-[(4-Carbamimidoyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid

Dabigatran impurity:

CAS No. 1408238-36-7

Chemical Name: 2-{[4-(Amino-hexyloxycarbonylimino-methyl)-phenylamino]-methyl}-1-methyl-1H-

benzoimidazole-5-carboxylic acid ethyl ester

Page 7 of 45

Dabigatran impurity:

Chemical Name: 2-[(4-Carbamimidoyl-phenylamino)-methyl]-1-methyl-1H-benzimidazole-5-carboxylic

acid

N

N HN

NH

NH2

HOOC

Duloxetine Hydrochloride EP - Impurities:-

Impurity A:

CAS No: 116539-60-7

Chemical name: (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl) propan-1-amine

Structure:

M.F: C18H19NOS

Mol. Wt.: 297.41

O

NH

CH3

S

Impurity B:

CAS No: 116539-55-0

Chemical name: (1S)-3-(methyl amino)-1-(thiophen-2-yl) propan-1-ol

Structure:

OH

NH

S

M.F: C8H13NOS

Mol. Wt.: 171.26

Impurity C:

Page 8 of 45

CAS No: 949095-98-1

Chemical name: 4-[(1RS)-3-methylamino)-1-(thiophen-2-yl) propyl] naphthalene-1-ol.

Structure:

S

M.F: C18H19NOS

Mol. Wt.: 297.41

OH

HN

CH3

Impurity E:

CAS No: 1033803-59-6 (base); 1033719-36-6 (HCl salt)

Chemical name: 1-[(1RS)-3-(methyl amino)-1-(thiophen-2-yl) propyl] naphthalene-2-ol.

Structure:

OH

NH

S

M.F: C18H19NOS

Mol. Wt.: 297.41

Impurity F:

CAS No: 116817-28-8

Chemical name: (3S)-N-methyl-3-(naphthalene-1-yloxy)-3-(thiophen-3-yl)propan-1-amine.

Structure:

M.F: C18H19NOS

Mol. Wt.: 297.41

O

NH

CH3

S

Impurity G:

Page 9 of 45

CAS No: 321-38-0

Chemical name: 1-fluoronaphthalene.

Structure:

F

M.F: C10H7F

Mol. Wt.: 146.16

Donepezil Hydrochloride:-

Impurity-A:-

CAS No: 120014-30-4

Chemical name: 5, 6-Dimethoxy-2-(piperidin-4-ylmethyl)-indan-1-one

Structure:

NH

O

H3CO

H3CO

M.F: C17H23NO3

Mol. Wt.: 289.37

Impurity-B: -

CAS No:

Chemical name: (E)-4-[(5,6-Dimethoxy-1-oxo-1H-inden-2-yl)methyl]pyridine1-oxide

Structure:

N+

O

H3CO

H3COO-

M.F: C17H15NO4

Mol. Wt.: 297.31

Impurity-C:-

CAS No:

Page 10 of 45

Chemical name: 1-Benzyl-4-[(5,6-dimethoxy-1-oxo-2,3-dihydro-1H -inden-2-yl)methyl]

piperidine 1-oxide

Structure:

N+

O

H3CO

H3CO O-

M.F: C24H29NO4

Mol. Wt.: 395.49

Impurity-D:-

CAS No: 4803-57-0

Chemical name: 5,6-Dimethoxy-2-(pyridin-4-ylmethyl)indan-1-one

Structure:

N

O

H3CO

H3CO

M.F: C17H17NO3

Mol. Wt.: 283.32

Impurity-E:-

CAS No:

Chemical name: 2-[(1-Benzylpiperidin-4-yl) methyl]-3-hydroxy-5, 6-dimethoxy-1H-indan-1-

one

Structure:

N

O

H3CO

H3CO

M.F: C24H29NO4

Mol. Wt.: 395.49

OH

Page 11 of 45

Impurity-F:-

CAS No:

Chemical name: 2-[(1-Benzylpiperidin-4-yl)(hydroxy)methyl]-5,6-dimethoxyindan-1-one

Structure:

N

O

H3CO

H3CO

M.F: C24H29NO4

Mol. Wt.: 395.49

OH

Impurity-G:-

CAS No:

Chemical name: 1,1-Dibenzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl)methyl]piperidinium.

Structure:

N+

O

H3CO

H3CO

M.F: C31H36NO3+

Mol. Wt.: 470.62

Impurity-H:-

CAS No: 120013-45-8

Chemical name: 1-Benzyl-4-[(5,6-dimethoxyinden-2-yl)methyl]piperidine

Structure:

N

H3CO

H3CO

M.F: C24H29NO2

Mol. Wt.: 363.49

Page 12 of 45

Impurity-I:-

CAS No: 1034439-57-0

Chemical name: 1-Benzyl-4-[(5,6-dimethoxyinden-2-yl)methyl]piperidine

Structure:

N

H3CO

H3CO

M.F: C24H31NO2

Mol. Wt.: 365.51

Esomeprazole Magnesium Di & Trihydrate Impurities:

Impurity A:

CAS No: 37052-78-1

Chemical name: 5-methoxy-1H-benzimidazole-2-thiol.

Structure:

N

HN

SH

H3CO

M.F: C8H8N2OS

Mol. Wt.: 180.23

Impurity B:

CAS No: 110374-16-8

Chemical name: 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-

benzimidazole

Structure:

Page 13 of 45

N

HN

H3COS

NO

CH3

CH3

M.F: C16H17N3O2S

Mol. Wt.: 315.39

Impurity C:

CAS No: 73590-85-9

Chemical name: 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulfanyl]-1H-

benzimidazole (ufiprazole).

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3

M.F: C17H19N3O2S

Mol. Wt.: 329.42

Impurity D:

CAS No: -88546-558

Chemical name: 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulfonyl]-1H-

benzimidazole (omeprazole sulfone).

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3O

O

M.F: C17H19N3O4S

Mol. Wt.: 361.42

Page 14 of 45

Impurity E:

CAS No: 176219-04-8

Chemical name: 4-methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2-yl)sulfinyl]methyl]-3, 5-

dimethylpyridin-1-oxide.

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3

OO

M.F: C17H19N3O4S

Mol. Wt.: 361.42

Impurity F:

CAS No: 119141-89-8

Chemical name: 5-methoxy-2-[(R)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-

benzimidazole ((R)-omeprazole).

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3

O

M.F: C17H19N3O3S

Mol. Wt.: 345.42

Itraconazole Impurities:-

Impurity-A:

CAS No: 252964-68-4

Chemical Name: 4-[4-[4-(4-methoxyphenyl) piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-

2,4-dihydro-3H-1,2,4-triazol-3-one.

Structure:

Page 15 of 45

N N OCH3NN

N

O

H3C

CH3H

M.F: C23H29N5O2

Mol. Wt.: 407.51

Impurity- B:

CAS No: 854372-77-3

Chemical Name: 4-[4-[4-[4[[cis-2-(2,4-dichlorophenyl)-2-(4H-1,2,4]triazol-4-ylmethyl)-

1,3dioxolan-4-yl] methoxy]-phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-

dihydro-3H-1,2,4-triazol-3-one.

Structure:

N N ONO

O

H

N

NN

Cl

ClN

N

O

H3C

CH3H

M.F: C35H38Cl2N8O4

Mol. Wt.: 705.63

Impurity- C:

CAS No: 74855-91-7

Chemical Name: 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4]triazol-1-ylmethyl)-1,3-

dioxolan- 4-yl]methoxy]-phenyl]-piperazin-1-yl)phenyl-2-propyl-2,4-dihydro-3H-1,2,4-triazol-

3-one.

Structure:

Page 16 of 45

N N ONO

O

H

N

N

N Cl

ClN

N

O

H3C

M.F: C34H36Cl2N8O4

Mol. Wt.: 691.61

Impurity- D:

CAS No: 89848-49-7

Chemical Name: 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-

dioxolan-4-yl] methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-methylethyl)-2,4-dihydro-3H-1,2,4-

triazol-3-one.

Structure:

N N ONO

O

H

N

N

N Cl

ClN

N

O

H3C

CH3

M.F:C34H36Cl2N8O4

Mol. Wt.: 691.61

Impurity –E: Trans imp

CAS No: 84604-65-9

Chemical Name: 4-[4-[4-[4-[[trans-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-

dioxolan-4-yl] methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-

dihydro-3H-1, 2,4-triazol-3-one

Structure:

Page 17 of 45

N N ONO

O

H

N

N

N Cl

ClN

N

OCH3

H3CH

M.F: C35H38Cl2N8O4

Mol. Wt.: 705.63

Impurity- F:

CAS No: 89848-51-1

Chemical Name: 2-butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1ylmethyl)-

1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-3H-1,2,4-triazol-3-one

Structure:

N N ONO

O

H

N

N

N Cl

ClN

N

O

H3C

M.F: C35H38Cl2N8O4

Mol. Wt.: 705.63

Impurity- G:

CAS No:

Chemical Name: 4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-

dioxolan-4-yl] methoxy]phenyl]piperazin-1-yl)phenyl]-2-[[cis-2-(2,4-dichloro phenyl)-2-[1H-

1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro-3H-1,2,4-triazol-3-one.

Structure:

Page 18 of 45

N N ONN

N

O

OO

H

N

N

N Cl

Cl

OO

NN

N

Cl

Cl

M.F: C44H41Cl4N11O6

Mol. Wt.: 961.68

Lansoprazole impurities: Lansoprazole EP Impurity A ; Lansoprazole N-Oxide ; CAS # 213476-12-1 ; Chemical name: 2-[[[3-Methyl-1-oxido-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole

Lansoprazole EP Impurity B ; Lansoprazole USP Related Compound A ; Lansoprazole Sulfone ; CAS : 131926-99-3

Page 19 of 45

Lansoprazole EP Impurity F Sulfide ; 4-Desmethoxypropoxyl-4-Chloro Rabeprazole Sulfide ; Chemical name: 2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl)methyl]sulphinyl]-1H-benzimidazole ; CAS # 103312-62-5 ;

Omeprazole EP - Impurities:-

Impurity A:

CAS No: 37052-78-1

Chemical name: 5-methoxy-1H-benzimidazole-2-thiol.

Structure:

N

HN

SH

H3CO

M.F: C8H8N2OS

Mol. Wt.: 180.23

Impurity B:

CAS No: 110374-16-8

Chemical name: 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-

benzimidazole

Structure:

N

HN

H3COS

NO

CH3

CH3

M.F: C16H17N3O2S

Mol. Wt.: 315.39

Page 20 of 45

Impurity C:

CAS No: 73590-85-9

Chemical name: 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulfanyl]-1H-

benzimidazole (ufiprazole).

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3

M.F: C17H19N3O2S

Mol. Wt.: 329.42

Impurity D:

CAS No: 88546-55-8

Chemical name: 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)-methyl]sulfonyl]-1H-

benzimidazole (omeprazole sulfone).

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3O

O

M.F: C17H19N3O4S

Mol. Wt.: 361.42

Impurity E:

CAS No: 176219-04-8

Chemical name: 4-methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2-yl) sulfinyl] methyl]-3, 5-

dimethylpyridin-1-oxide.

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3

OO

M.F: C17H19N3O4S

Mol. Wt.: 361.42

Impurity F:

CAS No: 125656-82-8

Chemical name: 1, 3-Dimethyl-8-methoxy-12-thioxopyrido [1′, 2′:3, 4] imidazo [1, 2-a]

Benzimidazol-2(12H)-one

Page 21 of 45

Structure:

N

N

H3CO

N

S CH3

CH3

O

M.F: C16H13N3O2S

Mol. Wt.: 311.36

Impurity G:

CAS No: 125656-83-9

Chemical name: 1, 3-Dimethyl-9-methoxy-12-thioxopyrido [1′, 2′:3, 4] imidazo [1, 2-a]

Benzimidazol-2(12H)-one

Structure:

N

NN

S CH3

CH3

O

M.F: C16H13N3O2S

Mol. Wt.: 311.36

H3CO

Impurity H:

CAS No: 863029-89-4

Chemical name: 2-[[(4-Chloro-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-5-methoxy-1H-

benzimidazole

Structure:

N

HN

H3COS

N

CH3

CH3

ClO

M.F: C16H16ClN3O2S

Mol. Wt.: 349.84

Page 22 of 45

Impurity I:

CAS No: 158812-85-2

Chemical name: 5-Methoxy-2-[[(4-methoxy-3, 5-dimethylpyridin-2-yl) methyl] sulphonyl]-1H-

benzimidazole N-Oxide

Structure:

N

HN

H3COS

N

CH3

CH3

OCH3O

OO

M.F: C17H19N3O5S

Mol. Wt.: 377.41

Pantoprazole EP- Impurities:

Impurity A:

CAS No: 127780-16-9

Chemical name: 5-(difluoromethoxy)-2-[[(3, 4-dimethoxypyridin-2-yl) methyl] sulfonyl]-1H-

benzimidazole

Structure:

N

HN

SNO

O

F F

OCH3

OCH3O

M.F: C16H15F2N3O5S

Mol. Wt.: 399.37

Impurity B:

CAS No: 102625-64-9

Chemical name: 5-(difluoromethoxy)-2-[[(3, 4-dimethoxypyridin-2-yl) methyl] sulfanyl]-1H-

benzimidazole.

Page 23 of 45

Structure:

N

HN

SNO

F F

OCH3

OCH3

M.F: C16H15F2N3O3S

Mol. Wt.: 367.37

Impurity C:

CAS No: 97963-62-7

Chemical name: 5-(difluoromethoxy)-1H-benzimidazole-2-thiol.

Structure:

N

HN

SH

O

F F

M.F: C8H6F2N2OS

Mol. Wt.: 216.21

Impurity D:

CAS No: 624742-53-6

Chemical name: 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1-

methyl-1H-benzimidazole.

Structure:

Page 24 of 45

N

N

SNO

F F

OCH3

OCH3

HCH3

O

M.F: C17H17F2N3O4S

Mol. Wt.: 397.40

Impurity E:

CAS No:

Chemical name: Mixture of the stereo isomers of 6,6'-bis(difluoromethoxy)-2,2'-bis[[(3,4-

dimethoxy pyridin-2-yl) methyl]sulfinyl]-1H,1'H-5,5'-bibenzimidazolyl.

Structure:

N

OCH3

H3CO

S N

HN

O

O

F

O

F

F

N

NH

SO

N

OCH3

OCH3

F

M.F: C32H28F4N6O8S2

Mol. Wt.: 764.72

Impurity F:

CAS No: 721924-06-7

Chemical name: 6-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1-

methyl-1H-benzimidazole

Structure:

Page 25 of 45

N

N

SNH

OCH3

OCH3

OCH3

O

F

F

M.F:C17H17F2N3O4S

Mol. Wt.: 397.40

Rabeprazole EP Impurities:-

Impurity-A:-

CAS Number: - 117976-47-3

Chemical name: - 2-[[[4-(3-Methoxypropoxy)-3-methyl-pyridin-2-yl] methyl] sulfonyl]

Bezimidazole

Melting Point: - 64-66°C

Structure:-

N

O(CH2)3OCH3H3C

N

HN

S

O

O

M.F: C18H21N3O4S

Mol. Wt.: 375.44

Impurity-B:-

CAS Number: - 117977-21-6

Chemical name: - 2-[[[4-(3-methoxy propoxy)- 3-methyl-pyridin-2-yl] methyl] sulfanyl]-1H-

Bezimidazole

Melting Point: - 109-110°C

Structure:-

N

O(CH2)3OCH3H3C

N

HN

S

M.F:- C18H21N3O2S

Mol. Wt.: 343.44

Impurity-C:-

CAS Number: - 1163685-30-0

Page 26 of 45

Chemical name: - 1-(1H-Benzimidazol-2-yl)-3-methyl-4-oxo-1, 4-dihydropyridine-2-

carboxylate

Melting Point: - 130-134°C

Structure:-

N

HO2C

O

CH3

N

NH

M.F: C14H11N3O3

Mol. Wt.: 269.26

Impurity-D:-

CAS Number: - 924663-38-7

Chemical name: - 2-[[[4-(3-methoxy propoxy)-3-methyl-1-oxidopyridin-2-yl] methyl]

sulfinyl]-1H-benzimidazole

Melting point: - 161-163°C

Structure:-

N

O(CH2)3OCH3H3C

N

HN

S

O

OM.F:-C18H21N3O4S

Mol. Wt.: 375.44

Impurity-E:-

CAS Number: - 102804-77-3

Chemical name: 2-[[(4-Methoxy-3-methylpyridin-2-yl) methyl] sulfinyl]-1H-benzoimidazole

Melting point: - 141-143°C

Structure:-

N

OCH3H3C

N

HN

S

O

M.F: C15H15N3O2S

Mol. Wt.: 301.36

Page 27 of 45

Impurity-F:-

CAS Number: - 583-39-1

Chemical name: - 1, 3-dihydro-2H-benzimidazole-2-thione

Melting Point: - 300-304°C

Structure:-

N

HN

SH

M.F: C7H6N2S

Mol. Wt.: 150.20

Impurity-G:-

CAS Number: - 102804-82-0

Chemical name: 2-[[(4-Methoxy-3-methylpyridin-2-yl) methyl] sulfanyl]-1H-benzimidazole

Melting point: -

Structure:-

N

OCH3H3C

N

HN

S

M.F: C15H15N3OS

Mol. Wt.: 285.36

Impurity-H:-

CAS Number: - 168167-42-8

Chemical name: - 2-[[(4-chloro-3-methylpyridin-2-yl]) methyl] sulfinyl]-1H-benzimidazole

Melting Point: - 128-130°C

Structure:-

Page 28 of 45

N

ClH3C

N

HN

S

O

M.F:-C14H12ClN3OS

Mol. Wt.: 305.78

Impurity-I:-

CAS Number: - 924663-37-6

Chemical name: - 2-[[[4-(3-Methoxypropoxy)-3-methyl-1-oxido-2-pyridinyl] methyl] sulfonyl]-

1H-benzimidazole

Melting Point: - 153-156°C

Structure:-

N

O(CH2)3OCH3H3C

N

HN

S

O

OO

M.F: C18H21N3O5S

Mol. Wt.: 391.44

Impurity-K:-

CAS Number: - 615-16-7

Chemical name: - 1H-Benzoimidazol-2-ol

Melting Point: - 314-316°C

Structure:-

N

HN

OH

M.F: C7H6N2O

Mol. Wt.: 134.14

Page 29 of 45

Sertraline EP- Impurities:-

Impurity -A:

CAS No: 79836-45-6

Chemical name: (1RS, 4SR)-4-(3, 4-dichlorophenyl)-N-methyl-1, 2, 3, 4-terrahydronaphthalen-1-

amine

Structure:

H3C-HN H

H

M.F: C17H17Cl2N-

Mol. Wt.: 306.23

Cl Cl

Impurity -B:

CAS No: 52758-03-9

Chemical name: (1RS, 4RS)-N-methyl-4-phenyl-1, 2, 3, 4-tetrahydronaphthalen-1-amine

Structure:

H NH-CH3

H

M.F: C17H19N-

Mol. Wt.: 237.34

Page 30 of 45

Impurity -C:

CAS No: 79646-00-7

Chemical name: (1RS, 4RS)-4-(4-chlorophenyl)-N-methyl-1, 2, 3, 4-tetrahydronaphthalen-1-

amine

Structure:

H NH-CH3

H

M.F: C17H18ClN-

Mol. Wt.: 271.79

Cl

Impurity -D:

CAS No: 871838-58-3

Chemical name: (1RS, 4RS)-4-(3-chlorophenyl)-N-methyl-1, 2, 3, 4-tetrahydronaphthalen-1-

amine

Structure:

H NH-CH3

H

M.F: C17H18ClN-

Mol. Wt.: 271.79

Cl

Impurity -E:

CAS No: 611-71-2

Chemical name: (2R)-hydroxyphenylacetic acid ((R))-mandelic acid

Structure:

CO2H

OHH

M.F: C8H8O3

Mol. Wt.: 152.15

Page 31 of 45

Impurity -F:

CAS No: 155748-61-1

Chemical name: (4R)-4-(3, 4-dichlorophenyl)-3, 4-dihydronaphthalen-1(2H)-one

Structure:

H

O

M.F: C16H12Cl2O

Mol. Wt.: 291.17

Cl Cl

Impurity -G:

CAS No: 79617-98-4

Chemical name: (1R, 4R)-4-(3, 4-dichlorophenyl)-N-methyl-1, 2, 3, 4-tetrahydronaphthalen-1-

amine (Sertraline enantiomer)

Structure:

H NH-CH3

H

ClCl

M.F: C17H17Cl2N-

Mol. Wt.: 306.23

Page 32 of 45

Sertraline HCl EP impurity G:

CAS No.:79645-15-1 Molecular Formula: C17H17Cl2N. HCl Structure:

Quetiapine hemifumarate EP-impurities:-

1. Impurity-A

CAS No: - 844639-07-2

Chemical Name: - 2-[2-[4-(dibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl] ethoxy] ethyl

acetate

Structure:-

Page 33 of 45

S

N N

NO

O CH3

O

M.F: C23H27N3O3S

Mol. Wt.: 425.54

2. Impurity-B

CAS No: - 5747-48-8

Chemical Name: - 11-(piperazin-1-yl) dibenzo [b, f] [1, 4] thiazepine

Structure:-

S

N N

NH

M.F: C17H17N3S

Mol. Wt.: 295.40

3. Impurity-C

CAS No: -

Chemical Name: - 2-[2-[4-(dibenzo [b, f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl[4-

(dibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl] acetate

Structure:-

Page 34 of 45

S

N N

N

N

N

N

S

OO

O

M.F: C40H42N6O3S2

Mol. Wt.: 718.93

4. Impurity-D

CAS No: - 945668-94-0

Chemical Name: - 11, 11'-(Piperazin-1, 4- diyl) bis (dibenzo [b, f] [1, 4] thiazepine)

Structure:-

S

N N

N

S

N

M.F: C30H24N4S2

Mol. Wt.: 504.67

5. Impurity-E

CAS No: - 1371638-05-9

Chemical Name: - 11, 11’-[ethane-1, 2-diyl bis (oxyethane-2, 1-diylpiperazine-4, 1-diyl)]

bis (dibenzo [b, f] [1, 4] thiazepine)

Structure:-

Page 35 of 45

S

N N

N

S

NN

NOO

M.F: C40H44N6O2S2

Mol. Wt.: 704.95

6. Impurity-F

CAS No: - 848814-27-7

Chemical Name: - [2-[(2-amino-phenyl) thio] phenyl]-{4-[2-(2-hydroxy-ethoxy)-ethyl]-

piperazin-1-yl}-methanone

Structure:-

NH2

S

NO

NO

OH

M.F: C21H27N3O3S

Mol. Wt.: 401.52

7. Impurity-G

CAS No: - 3159-07-7

Chemical Name: - Dibenzo [b, f] [1, 4] thiazepin-11(10H)-one

Structure:-

S

HN

O

M.F: C13H9NOS

Mol. Wt.: 227.28

8. Impurity-H

CAS No: - 1076199-40-0

Chemical Name: - 2-[2-[4-(dibenzo [b, f] [1, 4] thiazepin-11-yl)-]-oxidopiperazin-1-yl]

Page 36 of 45

ethoxy] ethanol

Structure:-

S

N N

NO

OHO

M.F: C21H25N3O3S

Mol. Wt.: 399.51

9. Impurity-I

CAS No: - 329218-14-6

Chemical Name: - [2-[4-(dibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl] ethanol

Structure:-

S

N N

NOH

M.F: C19H21N3OS

Mol. Wt.: 339.45

10. Impurity-J

CAS No: - 1356906-17-6

Chemical Name: - 2-[2-[2-[2-[4-(dibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl] ethoxy]

ethoxy] ethoxy] ethanol

Structure:-

Page 37 of 45

S

N N

NO

OO

OH

M.F: C25H33N3O4S

Mol. Wt.: 471.61

11. Impurity-K

CAS No: - 111974-69-7

Chemical Name: - N-[2-[[2-[[4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl] carbonyl] phenyl]

sulfanyl] phenyl] acetamide

Structure:-

S

NO

NO

OH

NHH3C

O

M.F: C23H29N3O4S

Mol. Wt.: 443.56

12. Impurity-L

CAS No: -1371638-11-7

Chemical Name: - 2-[2-[4-(9-chlorodibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl]

ethoxy] ethanol

Structure:-

S

N N

NO

OHCl

M.F: C21H24ClN3O2S

Mol. Wt.: 417.95

13. Impurity-N

CAS No: -

Page 38 of 45

Chemical Name: - 2-[2-[4-[2-[2-[4-(dibenzo [b, f] [1, 4] thiazepin-11-yl) piperazin-1-yl] ethoxy]

ethyl] piperazin-1-yl] ethoxy] ethanol

Structure:-

S

N N

NO

N

NO

OH

M.F: C29H41N5O3S

Mol. Wt.: 539.73

14. Impurity-O

CAS No: - 844639-06-1

Chemical Name: - 11-[4-[2-[2-(triphenylmethoxy) ethoxy] ethyl] piperazin-1-yl] dibenzo

[b, f][1,4]thiazepine

Structure:-

S

N N

NO

O

M.F: C40H39N3O2S

Mol. Wt.: 625.82

15. Impurity-P

CAS No: -1011758-03-4

Chemical Name: - 11-(4-ethylpiperazin-1-yl] dibenzo [b, f] [1, 4] thiazepine

Structure:-

Page 39 of 45

S

N N

N CH3

M.F: C19H21N3S

Mol. Wt.: 323.46

16. Impurity-Q

CAS No: -

Chemical Name: - 4-(dibenzo [b, f] [1, 4] thiazepin-11-yl)-1, 1-bis [2-(2-hydroxyethoxy)

ethyl] piperazin-1-ium

Structure:-

S

N N

NO

OH

OOH

M.F: C25H34N3O4S

Mol. Wt.: 472.62

17. Impurity-R

CAS No: - 2459-05-4

Chemical Name: - (2E)-4-ethoxy-4-oxobut-2-enoic acid

Structure:-

HO2C O CH3

O

M.F: C6H8O4

Mol. Wt.: 144.13

18. Impurity-S

CAS No: - 329216-63-9

Page 40 of 45

Chemical Name: - 2-[2-[4-(5-oxydodibenzo[b, f][1,4]thiazepin-11-yl)piperazin-1-yl] ethoxy]

ethanol

Structure:-

S

N N

NO

OH

O M.F: C21H25N3O3S

Mol. Wt.: 399.51

19. Impurity-T

CAS No: - 5747-46-6

Chemical Name:- 11-(morpholin-4-yl) dibenzo [b, f] [1, 4] thiazepine

Structure:-

M.F: C17H16N2OS

Mol. Wt.: 296.39

S

NN

O

20. Impurity-U

CAS No: - 5786-26-5

Chemical Name: - Dibenzo [b, f] [1, 4] thiazepin-11-amine

Melting point: - 180-181°C

Structure:-

Page 41 of 45

S

N NH2

M.F: C13H10N2S

Mol. Wt.: 226.30

21. Impurity-V

CAS No: -

Chemical Name: - 2-[2-[4-(phenanthridin-6-yl] piperazin-1-yl] ethoxy] ethanol

Structure:-

N N

NO

OH

M.F: C21H25N3O2

Mol. Wt.: 351.44

22. Impurity-W

CAS No: -

Chemical Name: - 11-(4-[2-[2-(dibenzo [b, f] [1, 4] thiazepin-11-yloxy) ethoxy] ethyl]

piperazin-1-yl] dibenzo [b, f][1,4]thiazepine

Structure:-

S

N N

N N

S

OO

M.F: C34H32N4O2S2

Mol. Wt.: 592.77

Page 42 of 45

Luliconazole impurities:

Luliconazole impurity

CAS No: 187164-18-7

Chemical name: (-)-(E)-2-[4(R)-(4-chloro phenyl)-1,3 dithiolan-2ylidine]-2-(1H-Imidazol-

1yl)acetonitrile Molecular Formula: C14H10ClN3S2

Structure:

Luliconazole impurity: Luliconazole-Z- isomer

Chemical name: (2Z)-[(4R)-4-(2,4-dichloro phenyl-1,3 dithiolan-2-ylidene]-2-Imidazole-1-yl acetonitrile

CAS No.: 1240249-76-6

Molecular Formula: C14H9Cl2N3S2

Structure:

Luliconazole impurity:

CAS No.: NA

Chemical name: (2Z)-[(4S)-4-(2,4 dichloro phenyl)-1,3 dithiolan-2-ylidene]-2-Imidazole-1-yl acetonitrile

S

S

CN

NN

Cl

Page 43 of 45

Structure:

Luliconazole impurity: (S)-Luliconazole-E-isomer

CAS No.: 258424-63-2

Chemical name: (2E)-[(4S)-4-(2,4-di chloro phenyl]-1,3 dithiolan-2-ylidene]-2-Imidazole-1-yl acetonitrile

Molecular Formula: C14H9Cl2N3S2

Structure:

Pramipexole dihydrochloride monohydrate EP Impurities:

Impurity–A:

CAS No: 106092-09-5

Chemical name: (6S)- 4, 5, 6, 7-Tetrahydro-1, 3-benzothiazole-2, 6-diamine

Structure:

NC

N

N

S

S

Cl

Cl

Page 44 of 45

N

SNH2H2N

H

M.F: C7H11N3S

Mol. Wt.: 169.25

Impurity–B:

CAS No: 1246815-83-7

Chemical name: (6S) - N, N1-dipropyl-4, 5, 6, 7-Tetrahydro-1, 3-benzothiazole-2, 6-diamine

Structure:

N

SNH

HNH CH3

H3C

M.F: C13H23N3S

Mol. Wt.: 253.41

Impurity –C:

CAS No:

Chemical name: Mixture of diasteroisomers of (6S)-6N-[3-{(6S)-2-amino-4, 5, 6, 7-tetrahydro-

1,3-benzothiazole 6yl} 1ethyl 2-methylpropyl] 4, 5, 6, 7-Tetrahydro-1,3-benzothiazole-2,6 -

diamine.

Structure:

N

SNH2

HNH

H3C

H3C

HN

N

SH2N H

M.F: C20H32N6S2

Mol. Wt.: 420.64

Impurity–D:

CAS No: 104632-26-0

Chemical name: (6R)-6-N-propyl-4, 5, 6, 7-tetrahydro-1, 3-benzothiazole-2, 6-diamine

Page 45 of 45

Structure:

N

SNH2

H

HNH3C

M.F: C10H17N3S

Mol. Wt.: 211.33

Impurity –E:

CAS No: 106006-84-2

Chemical name: N-[(6S)-2-amino-4, 5, 6, 7-tetrahydro-1, 3-benzothiazole-6-yl] propanamide

Structure:

N

SNH2

H

HNH3C

O

M.F: C10H15N3OS

Mol. Wt.: 225.31