n h .h 2s o 4 h o - crimson international · 2016-11-05 · amlodipine ep impurity d ; amlodipine...

Abacavirsulfate

Chemical Name Impurity Name M.Wt & M.Formula Structure

N6 -cyclopropyl-9H-purine-2,6-

diamine

PYRIDINE IMP

C8H10N6 190.21

NH

N

N

N

HN

NH2

(1S,4R)-4-[2-Amino-6-(cyclopopylamino)-9H-purin-9-yl]-

1-(2,5-diamino-6-chloro-4-pyrimidinyloxy)methyl-2-

cyclopentene

O-PIRIMIDINY IMP

C18H21ClN10O 428.88

N N

Cl

NH2

NH2

O

N

N

N

N

NH2

HN

(1S,4R)-4-(2- Amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-

methanol hydrochloride

Penaultimate IMP

C11H13Cl2N5O 302.16

HO

N

N

N

N

NH2

Cl

.HCl

(1S, 4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]

cyclopentatne-1- methanol sulfate.

DIHYDRO USP-B

C30H42N10O2.H2SO4

674.77

HO

N

N

N

N

NH2

2

.H2SO4

(1S,R)-4-[2,6-Diamino-9H-purin-9-yl -2-cyclopentene-1-methanol

DES CYCLO C11H14N6O 246.27

HO

N

N

N

N

NH2

NH2

Alfuzosin hydrochloride

N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-

yl)(methyl)amino]propyl] formamide

EP-C C19H28ClN5O4 M.Wt:425.91

N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-

yl](methyl)amino]propyl]furan-2-carboxamide hydrochloride

EP-A C19H23N5O4 385.18

N

N

NH2

O

O NHN

O

O

2-Chloro-6,7-dimethoxyquinazolin-4-amine

Ep-B C10H10 Cl N3O2 239.05,

N

N

NH2

O

O

Cl

N-(4-Amino-6,7-

dimethoxyquinazolin-2yl)-N-methylpropane-1,3-diamine

hydrochloride salt.

EP-D

C14H21N5O2 291.17

N

N

NH2

O

O N NH2

Amlodipine

3-Ethyl5-methyl(4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2-

(methylcabanoyl)benzoyl]amino]ethyl]methyl]-1,4-.(EP-B)

Amlodipine Impurity B

C29H32ClN3O7 570.03

HN

NH

O

O

OHN O

O

OOCl

3-Ethyl5-methyl(4RS)-4-(2-Chlorophenyl)—[[2-(1,3-dioxo-1,3-

dihydro-2H-isonido-2-yl)ethoxy]methyl]-6-methyl-

1,4dihydropyridine-3,5-dicarboxylate.

EP-A C28H27ClN2O7 538.98 H

N

H3CO

O Cl

OC2H5

O

O N

O

H3C

O

3-Ethyl5-methyl2-[(2-aminoethoxy)methyl]-4-(2-

chlorophenyl)-6-methylpyridine-3,5-dicarboxylate

Amlodipine EP

Impurity D ;

Amlodipine

Related

Compound A ;

Dehydro

Amlodipine

Oxalate

C22H25ClN2O9 ;

MW: 496.89

Cl

N

MeOOC O

O NH2

OO

O

OH

OH

Aprepitant

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.

C23H21F7N4O3 534.43

O

N

O

H3C

CF3

CF3

HN

HN NO F

Methyl2-[2-((2R,3S)-2-((IR)-1-(3,5-bis(trifluoromethyl)phenyl)ehoxy)-3-(4-fluorophenyl)-4-morpholinyl)-1-iminoethyl]hydrazine carboxlate

C24H25F7N4O4 566.47

CF3

CF3OO

N

H3C

HN

NH

NHO

F

OH3C

(IR)-1-[3,5-Bis(trifluoromethyl)phenyl](2R,3S)-

3-(4-Flurophenyl) morpholinyl ether,p-toluene sulfonic acid salt,

Aripiprazole

7-(4-Bromobutoxy)-1,2,3,4-tetrahydroquinoline-2-one.

C13H16BrNO2 298.18

NH

OBr O

1-(2,3-Dichlorophenyl)piperazine hydrochloride.

C10H13Cl3N2 267.58

Cl

Cl

N

NH. HCl

1-[4-[4-(2,3-Dichlorohenyl)piperazin-1-yl]butyl]-

7-hydroxy-3,4-dihydrocarbostyril

C23H27Cl2N3O2 448.39

Cl

Cl

N

NN

O

OH

6-[4-[(2-oxo-1,2,3,4-terahydro-7-quinolinyl)oxy]butoxy]-1,2,3,4-

tetrahydro-2-quinolinone

--------

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

2(IH)-quinolinone.-N-oxide

N-OXIDE C23H27Cl2N3O3 464.38

ClCl

N

NO

HN O

O

Atomoxetine Hcl

S(+) N-Methyl-3-(2-methylphenoxy)-3-

phenylpropylamine hydrochloride.

C17H22ClNO 291.82

O

CH3

HN CH3

. HCl

Phenyl-N-methyl-N-[3-(-O-tolyloxy)-3-

phenylpropyl]carbamate.

C25H26O3 374.47

O

CH3

O

O

CH3

L(+)- Mandelic acid.

C8H8O3 152.15

O

OH

HO

H

Atorvastatin calcium

7-[2-(4-Fluoro-phenyl)-5-isopropyl-

3-phenyl-4-phenylcarbamoyl-

pyrrol-1-yl]-3,5-dihydroxy-

heptanoic acid methyl ester

Methyl ester

C34H37FN2O5 572.67

NH

O

N

O

O CH3

F

OH

OH




heptanoic acid ethyl ester

Ethyl ester

C35H39FN2O5 587

NH N

OH

OH

F

O

O C2H5

O

5-(4-Fluoro-phenyl)-1-[2-(4-

hydroxy-6-oxo-tetrahydro-pyran-2-

yl)-ethyl]-2-isopropyl-4-phenyl-1H-

pyrrole-3-carboxylic acid

phenylamide

Lactone imp

C33H33FN2O4 540.62

NH

NO

O

OH

HO

F

2-[2-(4-Fluoro-phenyl)-2-oxo-1-

phenyl-ethyl]-4-methyl-3-oxo-

pentanoic acid phenylamide

Diketo compound

C26H24FNO3 417.47

NH

O

O

O

F




heptanoic acid tert-butyl ester

Tertiary butyl

ester

C37H43FN2O5 615

NH

NO

HOHO

O

O

F

(6-{2-[2-(4-Fluoro-phenyl)-5-

isopropyl-3-phenyl-4-

phenylcarbamoyl-pyrrol-1-yl]-

ethyl}-2,2-dimethyl-[1,3]dioxan-4-

yl)-acetic acid tert-butyl ester

C40H47FN2O5 654.81

NH N

O

F

O O O

O

2-[1,2-Bis-(4-fluoro-phenyl)-2-oxo-

ethyl]-4-methyl-3-oxo-pentanoic

acid phenylamide

C26H23F2NO3 435.46

NH

O

O

O

F

F

(6-{2-[2,3-Bis-(4-fluoro-phenyl)-5-

isopropyl-4-phenylcarbamoyl-

pyrrol-1-yl]-ethyl}-2,2-dimethyl-

[1,3]dioxan-4-yl)-acetic acid tert-

butyl ester

C40H46F2N2O5 672.80

NH

NO

OO

O

O

F

F

(6-{2-[2-(4-Fluoro-phenyl)-5-


phenylcarbamoyl-pyrrol-1-yl]-

ethyl}-2,2-dimethyl-[1,3]dioxan-4-

yl)-acetic acid tert-butyl ester

C40H47FN2O5Mol. Wt.: 654.8

NNH

O

O

O

O

O

F

2-[1,2-Bis-(4-fluoro-phenyl)-2-oxo-

ethyl]-4-methyl-3-oxo-pentanoic

acid phenylamide

Difluoro impurity C26H23F2NO3

435.46

NH

O

O

O

FF

(6-{2-[2,3-Bis-(4-fluoro-phenyl)-5-


pyrrol-1-yl]-ethyl}-2,2-dimethyl-

[1,3]dioxan-4-yl)-acetic acid tert-

butyl ester

C40H46F2N2O5Mol. Wt.: 672.8

NNH

O

O

O

O

O

F

F

7-[2,3-Bis-(4-fluoro-phenyl)-5-



heptanoic acid tert-butyl ester

C37H42F2N2O5Mol. Wt.: 632.7

NNH

O

OH

OH

O

O

F

F

Atorvastatin Calcium Difluoro impurity (C33H33F2N2O5)2-

Ca

W.wt: 1190

N

NH

O

O

OH

OH

O

F

F

2

Ca2

3-(4-Fluoro-benzoyl)-2-isobutyryl-3-

phenyl-oxirane-2-carboxylic acid

phenylamide

Oxirane impurity C26H22FNO4

431.46 NH

O

O

O F

O

3-(4-Fluoro-benzoyl)-2-isobutyryl-3-

phenyl-oxirane-2-carboxylic acid

phenylamide

C26H22FNO4

431.46 NH

O

O

O F

O




heptanoic acid

SS isomer C33H35FN2O5

559

NH

NO (S) (S)

HOO

OH

F

HO

2-Isopropyl-4,5-diphenyl-1H-

pyrrole-3-carboxylic acid

phenylamide

C26H24N2O

380.48

NH

ONH

{6-[2-(2-Isopropyl-4,5-diphenyl-3-

phenylcarbamoyl-pyrrol-1-yl)-

ethyl]-2,2-dimethyl-[1,3]dioxan-4-

yl}-acetic acid tert-butyl ester

C40H48N2O5Mol. Wt.: 636.82

NH

NO

OO O

O

3,5-Dihydroxy-7-(2-isopropyl-4,5-

diphenyl-3-phenylcarbamoyl-

pyrrol-1-yl)-heptanoic acid tert-

butyl ester

C37H44N2O5Mol. Wt.: 596.76

NH

NO

HOHO O

O

Atorvastatin Calcium Desfluoro

impurity of

Atorvastatin Ca

(C33H35N2O5+)2Ca

M.Wt: 1118 NH

N

OH

OH

O

O-

O

Ca+2

C33H35CaN2O5+

579.72

2




heptanoic acid

Atorvastatin

Calcium

diasteriomer

C33H35FN2O5Mol. Wt.: 558.64

NH

NO

HOHO O

OHH

H

F

7-{7-[2-(4-Fluoro-phenyl)-5-


phenylcarbamoyl-pyrrol-1-yl]-3,5-

dihydroxy-heptanoylamino}-3,5-

dihydroxy-heptanoic acid

Di Amino

impurity

C40H48FN3O8Mol. Wt.: 717.82

NH

NO

HOHO O

NH

FOH

OH

O

HO



pyrrol-1-yl]-3-hydroxy-5-methoxy-

heptanoic acid

Methoxy

impurity

C34H37FN2O5

572.67 NH N

OH

OCH3

F

O

OH

O



pyrrol-1-yl]-5-hydroxy-hept-2-enoic

acid

Heptenoic acid C33H33FN2O4

540.62

NH

NO

HOO

OH

F

Bicalutamide

N-[4-Cyano-2-(trifluoromethyl)phenyl]-3-[(4-

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

C18H14F4N2O4S 430.17

NC

CF3 HN

O

H3C OH

S

F

O

O


fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-propanamide.

C18H14F4N2O4S 430.17

NC

HN

O

H3C OH

S

F

O

O

F3C


fluorophenyl)sulfinyl]-2-Acetyloxy-2-methylpropanamide.

C20H16F4N2O5S 472.21

NC

HN

O

H3C O

S

F

O

O

F3C

CH3O

4-Fluorobenzene sulphonic acid.

C6H5FO3S 176.17 F S

O

O

OH

2,3-Epoxy-2-mehyl-N-[4-Cyano-3-(trifluoromethyl)phenyl]propanami

de

C12H9F3N2O2 270.21

NC

HN

O

CH3

OF3C


fluorophenyl]thio]-2-hydroxy-2-methylpropanamide

C18H14F4N2O2S 398.37

NC

HN

O

H3C OH

S

F

F3C

N-[4-Cyano-3-(trifluoromehtyl)phenyl]-3-[(3-

fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide.

C18H14F4N2O4S 430.17

NC

HN

O

H3C OH

SO

O

F3C F

N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(4-

fluorophenyl)sulfonyl]-2-methylpropanamide.

C18H14F4N2O3S 414.07

NC

HN

O

H3C

SO

O

F3C

F

N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(4-

fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide.

C18H14F4N2O3S 414.37

NC

HN

O

H3C OH

SO

F3C

F N-[4-Cyano-3-

(trifuoromethyl)phenyl]-3-[(phenyl)sulfonyl]-2-hydroxy-2-

methylpropanamide.

C18H15F3N2O4S 412.39

NC

HN

O

H3C OH

SO

O

F3C

4-Amino -2-(trifluoromethyl) benzonitrile

C8H5N3F2 186.13

N

F

F

F

H2N 4-Amino -3-

(trifluoromethyl)benzonitrile.

C8H5N3F2 186.13

N

F

FF

H2N

Candesartan cilexetil

Triphenyl methane

C19H16 244.33

H

Triphenyl methanol

C19H16O 260.33

OH

2-Hydroxy-1-**2’-(1H-tetrazol-5-yl)*1,1’-biphenyl]-4-yl]mehtyl]-1H-Benzimidazole-7-carboxylic acid.

C24H20N6O3 440.45

N

N

HO O

O

CH3

NH

NN

N

2-hydroxy-1-**2’-(1H-tetrazol-5-yl)*1,1’-biphenyl]-4yl]mehtyl]-1-

[[(Cyclohexyloxy)carbonyl]oxy)carbonyl]ethyl ester H-Benzimidazole-7-

carboxylate

C31H30N6O6 582.61

N

N

O O

OH

NH

NN

N

O

CH3

O

O

Ethyl 2-ethoxy-1-**2’-(1H-tetrazole-5-yl)*1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylate.

C26H24N6O3 468.51

N

N

O O

O

NH

NN

NCH3

2-Ethoxy-1-**2’-(1H-tetrazole-5-yl)*1,1’-biphenyl]-4-yl]methyl]-1H-Benzimidazole-7-carboxylic acid.

C24H20N6O3 440.45

N

N

HO O

O

NH

NN

N

1-(Cyclohexyloxycarbonyloxy)ethyl2-

ethoxy-1-**2’-(N-tryphenylmethyltetrazole-5-

yl)biphenyl-4-yl]mehtyl]

C52H48N6O6 852.97

N

N

O O

O

N

NN

N

CH3

O

CH3

O

O

Capecitabine

5’-Deoxy-5-fluorouridine

USPRCB C9H11FN2O5 246.20

N

HN

F

O

O

HOOH

H3C

O

5’3-Di-O-acetyl-5’deoxy-5-fluorocytidine.

C13H16FN3O6 329.28

N

N

F

O NH2

O

O CH3OOH3C

O

H3C

5 5’-Deoxy-5-fluoro-N4-(2-Methyl-1-butyloxycarbonyl)cytidine.

C15H22FN3O6 359.35

N

N

F

O NH

O

OH

HO

H3C

O

O

CH3

CH3

5’Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidine.

C15H22FN3O6 359.35

N

N

F

O NH

O

OH

HO

H3C

O

O

CH3

CH3

5’-Deoxy-5-fluorocytidine

USPRCA C9H12FN3O4 245.21

N

N

F

NH2

O

HOOH

H3C

O

2',3'-O-cabonyl-5'-deoxy-5-fluoro-N4-(pentyloxycarbonyl)cytiidine

USP-C C16H20FN3O7 385.34

N

N

F

HN O

OO

OO

H3C

O

O

CH3

2',3'-O-DIacetyl-5'-deoxy-5-fluorocytiidine

C13H16FN3O6 329.28

N

N

F

NH2

O

OO

H3C

O

H3C

O

CH3

O

Cetirizine dihydrochloride

Methyl-[3-phenyl-3-(4-

trifluoromethyl-phenoxy)-propyl]-

amine

Impurity-A C17H18F3NOMol. Wt.: 309.33

F3C

O NH

{4-[(4-Chloro-phenyl)-phenyl-

methyl]-piperazin-1-yl}-acetic acid

Acid impurity

C19H21ClN2O2

Mol. Wt.: 344.84 Cl

N

N

O

OH

(2-{4-[(2-Chloro-phenyl)-phenyl-

methyl]-piperazin-1-yl}-ethoxy)-

acetic acid

Impurity-C/ 2-

Chloro analog

C21H25ClN2O3

Mol. Wt.: 388.89

N

NO

OH

O

Cl



acetic acid

3-Chloro analog

C21H25ClN2O3

Mol. Wt.: 388.89

N

NO

OH

OCl

1,4-Bis-[(4-chloro-phenyl)-phenyl-

methyl]-piperazine

Impurity-D C30H28Cl2N2

Mol. Wt.: 487.46

N N

Cl

Cl

2-{4-[(3-Chloro-phenyl)-phenyl-

methyl]-piperazin-1-yl}-ethanol

C19H23ClN2OMol. Wt.: 330.85

N N

Cl

OH

1-[(2-Chloro-phenyl)-phenyl-

methyl]-piperazine

C17H19ClN2Mol. Wt.: 286.80

Cl

N

NH

[2-(2-{4-[(4-Chloro-phenyl)-phenyl-


ethoxy]-acetic acid

Impurity-E/

Diether impurity

C23H29ClN2O4Mol. Wt.: 432.94 N

NO

O

O

OHCl

[2-(4-Benzhydryl-piperazin-1-yl)-

ethoxy]-acetic acid

Impurity-F/ Des

chloro imp

C21H26N2O3Mol. Wt.: 354.44

N

NO

OH

O



acetic acid ethyl ester

Ethyl ester

impurity

C23H29ClN2O4

Mol. Wt.: 432.94

N

NO

OCl

O



acetic acid methyl ester

Methyl ester

C22H27ClN2O3Mol. Wt.: 402.91

N

NO

OCl

O

Ciprofloxacin hcl

7-(2-Amino-ethylamino)-1-

cyclopropyl-6-fluoro-4-oxo-1,4-

dihydro-quinoline-3-carboxylic acid

C15H16FN3O3Mol. Wt.: 305.30

N

O O

OHF

HN

H2N

6-Chloro-1-cyclopropyl-4-oxo-7-

piperazin-1-yl-1,4-dihydro-

quinoline-3-carboxylic acid

Chloroanalog C17H18ClN3O3

347.80

NN

HN

Cl

O O

OH

7-Chloro-1-cyclopropyl-4-oxo-6-

piperazin-1-yl-1,4-dihydro-


C17H18ClN3O3

347.80

NCl

O

N

HN O

OH

1-Cyclopropyl-4-oxo-7-piperazin-1-

yl-1,4-dihydro-quinoline-3-

carboxylic acid

Desfluoro

C17H19N3O3

313.35

NN

HN

O O

OH

7-Chloro-1-cyclopropyl-6-fluoro-4-

oxo-1,4-dihydro-quinoline-3-

carboxylic acid

Q.Acid

C13H9ClFNO3

281.67

NCl

O O

OHF

1-Cyclopropyl-6-fluoro-7-piperazin-

1-yl-1H-quinolin-4-one

Decarboxylated

imp

C16H18FN3O

287.33

NN

O

F

HN

Clopidogrel bisulphate

(2-Chloro-phenyl)-(4-mercapto-5-

methyl-3,6-dihydro-2H-pyridin-1-

yl)-acetic acid

Related compound-A

(USP) /

C15H14ClNO2S 307.80

N

Cl

COOH

S

H

.HCl

(2-Chloro-phenyl)-(4,7-dihydro-5H-

thieno[2,3-c]pyridin-6-yl)-acetic

acid methyl ester

Related compound-B

C16H17Cl2NO2S 358.28

NS

Cl

COOCH3

.HCl



acid methyl ester

Related compound-C

C16H16ClNO2S 321.06 N

S Cl

COOCH3

.H2SO4 Clopidogrel premix

4,5,6,7-Tetrahydro-thieno[3,2-

c]pyridine

Impurity-A

C7H10ClNS

175.68

NH.HCl

S

6,7-Dihydro-5H-thieno[3,2-

c]pyridin-4-one

Impurity-B

C7H7NOS

153.20 NH

S

O



acid

Impurity-C /Acid

impurity

C15H14ClNO2SMol. Wt.: 307.8

Cl

N

OHO

S

5-[(2-Chloro-phenyl)-

methoxycarbonyl-methyl]-6,7-

dihydro-thieno[3,2-c]pyridin-5-ium

Impurity-

/Dehydro

impurity

C16H15ClNO2S+

320.81

N

S Cl

OO

(2-Chloro-phenyl)-(2-thiophen-2-yl-

ethylamino)-acetic acid methyl

ester

Impurity-E/

Open chain comp


HN

S Cl

OO



acid methyl ester

Impurity-F

/Regio Isomer

C16H17Cl2NO2S

358.28 NS

Cl.HCl

O

O



acid methyl ester

Impurity-G /R-

Isomer


N

O O

S Cl

Amino-(2-chloro-phenyl)-acetic

acid methyl ester

C9H10ClNO2Mol. Wt.: 199.6

H2N

O O

Cl


ethylamino)-acetic acid methyl

ester


Cl

HN

O O

S

(2-Chloro-phenyl)-(2-

hydroxymethyl-6,7-dihydro-4H-


acid methyl ester

Alchohol impurity


N

O O

SHO Cl


ethylamino)-acetic acid

C14H14ClNO2S

295.78

HN

S

COOH

Cl

Cyclobenzaprine hydrochloride

5-(3-Dimehylaminopropyl)-5-hydroxydibenzo[a,e]cyclo

heptatriene.

C19H22NO 280.38

OH

N

5H-Dibenzo[a,d]cycloheptaten-5-ol

C16H11O3-

251.26

O-O

OH

Desvenlafaxine succinate

1-[2-(Dimethylamino)-1-(4-benzyloxyphenyl)ethyl]cyclohexano

l.

C23H31NO2 353.50

O

N

HO

Dexlansoprazole

2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-

pyridinyl]methyl]sulfinyl-1H-benzimidazole1’-oxide.

C16H14F3N3O3S 385.36 N

NH

S

O N+

OF

F

F

-O


pyridinyl]methyl]thio]-1H-benzimidazole.

C16H14F3N3OS 353.36

N

NH

S

N

OF

FF


pyridyl]methyl]sulfonyl-1H-benzimidazole.

C16H14F3N3O3S 385.36 N

NH

S

O

O N

O

F

FF

Dexpramipexole dihydrochloride

(R)-N2,N

6-Dipropyl-4,5,6,7-

terthydrobenzo[d]thiazol-2,6-diamine.

---------

(6R)-6-N-ethyl-4,5,6,7-tertrahydro-1,3-benzothiazol-2,6-diamine

dihydrochloride

C10H19Cl2N3S 284.25

N

SHN

HH3C

NH2 .2HCl

(6R)-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-2,6-diamine.

C7H11N3S 169.25

S

N

H2NNH2

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

2,6-benzothiazolediamine dihydrochloride

-------

N-(6R)-2-Amino-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-6-

yl]propanamide

C10H15N3OS 225.31 O

NHS

N

H2N

Donepezil hcl

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

inden-2-ylmethyl)-piperidine Indene Impurity

C24H29NO2 Mol. Wt.: 363.49

O

O N

5,6-Dimethoxy-2-piperidin-4-

ylmethyl-indan-1-one

C17H23NO3 Mol. Wt.: 289.37 O

O NH

O

1-Benzyl-4-(5,6-dimethoxy-indan-2-

ylmethyl)-piperidine Desketo impurity

C24H31NO2 Mol. Wt.: 365.51

O

O N

5,6-Dimethoxy-2-pyridin-4-

ylmethyl-indan-1-one Methyl impurity

C17H17NO3 Mol. Wt.: 283.32

OO

O

N

2-(1,1-Dibenzyl-piperidin-4-

ylmethyl)-5,6-dimethoxy-indan-1-

one

Dibenzyl impurity

C31H36NO3 Mol. Wt.: 470.62 O

O

N

O

2-(1-Benzyl-piperidin-4-

ylmethylene)-5,6-dimethoxy-indan-

1-one Alkene Impurity

C24H27NO3 Mol. Wt.: 377.48 O

O N

O

2,3-Dihydro-5,6-dimethoxy-2-[(4-pyridinyl)methyl]-1H-inden-1

C18H28ClNO3 341.87

OOH3C

OH3C

NH

.HCl

1-Benzyl-4-[3-(benzyloxy)-5,6-dimethoxy-1H-2-

indenyl]methylpiperidine,Hydrochloride

C31H36ClNO3 506.08

N

O

OO

HCl

1-Benzyl-4-[(5,6-dimethoxy-1H-inden-2-

yl)methyl]piperidine,hydrochloride.

C26H38ClNO2 432.04 OH3C

OH3C

N.HCl

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

C17H17NO3 283.32

OOH3C

OH3C

N 2,3-Dihydro-5,6-dimethoxy-2-[(4-

piperidinyl)methyl-1-one-hydrochloide.

-------

1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-inden-2-

yl)methyl]piperdine hydrochloride.

C26H40ClNO2 434.05 OH3C

OH3C

N.HCl

1,1-Dibenzyl-4-[(5,6-dimethoxy-1-

oxo-2,3-dihydro-1H-inden-2-yl)methyl]piperidinium bromide.

-------

Dorzolamide hydrochloride

(4R,6R)-4-(Ethylamino)-5,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-

thiopyran-2-sulfonamide-7,7-dioxide hydrochloride. (R,R-isomer-

92% ) (S,S –isomer-8%)

USPRCA C10H17ClN2O4S3 360.90 S S

H3CO

HN CH3

S

OO

NH2 .HCl

O

(4R,6S)-4-(Ethylamino)-5,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-

thiopyran-2-sulfonamide-7,7-dioxide hydrochloride .

C10H17ClN2O4S3 360.90 S S

H3CO

HN CH3

S

OO

NH2 .HCl

O

(4S,6S)-4-(Acetylamino)-5,6,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-

thiopyran-2-sulfonamide-7,7-dioxide

C10H14N2O5S3 338.43 S S

H3CO

HN CH3

S

OO

NH2

O

O

Doxazosin mesylate

(2,3-Dihydro-benzo[1,4]dioxin-2-yl)-piperazin-1-yl-methanone

EP-B C13H16N3O2 248.28

O

ON

O

NH

4-amino-2-chloro-6,7-dimethoxy quinazoline.

EP-F C10H10ClN3O2 239.66

N

N

O

O

Cl

NH2

4-amino-2-(1-Piperazinyl)-6,7-dimethoxy quinazoline.

EP-G C14H19N5O2 289.33

N

N

O

O

NHN

NH2

Duloxetine hydrochloride

(R,S)-N-Methyl-3-(1-Naphthyloxy)-3-(3-thienyl)propanamine.

C18H19NOS 297.41

HN

SO

(S)-N-Methyl-N-phenyloxy carbonyl-3-(1-naphthyloxy)-3-(2-

thienyl)propylamine.

C25H23NO3S 417.52

N

S

O

O

O

Napthalene

C10H8 128.17

1-Napthol

C10H8O 144.17

OH

(R)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine.

C18H19NOS 297.41

HN

SO

Dutasteride

4a,6a-Dimethyl-2-oxo-

2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11

a-tetradecahydro-1H-indeno[5,4-

f]quinoline-7-carboxylic acid amide

C19H28N2O2

316

NH

O

NH2

O

H


hexadecahydro-indeno[5,4-

f]quinoline-7-carboxylic acid (2,5-

bis-trifluoromethyl-phenyl)-amide

Dihydro impurity

C27H32F6N2O2Mol. Wt.: 530.55

NH

HN

CF3

O

O

F3CH


hexadecahydro-indeno[5,4-

f]quinoline-7-carboxylic acid amide

Dihydro

C19H30N2O2Mol. Wt.: 318.45

NH

O

ONH2

H


2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11


f]quinoline-7-carboxylic acid

C19H27NO3Mol. Wt.: 317.42

NH

O

OOH

H

H

2-Iodo-1,4-bis-trifluoromethyl-

benzene

C8H3F6IMol. Wt.: 340.00

CF3

I

CF3

2-Hydroxy-6a-methyl-6,6a,7,8,9,9a-

hexahydro-5H-indeno[5,4-



Desmethyl

C26H22F6N2O2

508.46

N

NH

F3C

HO

O

CF3


2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11




ISOMER C27H30F6N2O2

529

NH

O

NHO

CF3

F3C

H

H

H

H

Efaverinz

(S)-6-Chloro-4-pent-1-inyl-4-trifluoro methyl-1,4-

dihydrobenzo[d]-1,3-oxazin-one.

-----

(S)-6-chloro-4-cylopropyl ethinyl-1-(4-methoxybenzyl)-4-trifluoromethyl-1,4-

dihydrobenzo[d]-1,3-oxazin-2-one.

C22H17ClF3NO3 435.82

N O

O

F F

F

Cl

OH3C

(S)-6-Chloro-4-trifluoromethyl-4-cyclopropylethenyl-1H-benzo[d]-

1,3-oxanzin-2-one

C14H11ClF3NO2 317.69

HN O

O

F F

F

Cl

CH3

6-chloro-1-(1S)-camphanoyl-4-4S-(cyclopropylethenyl)-

trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one.

C24H23ClF3NO5 497.89

N

O

O

OOO

Cl

F

FF

(S) -5-Chloro-α-(cyclopropylethynyl)-2-amino- α -

(trifluoromethyl)-benzene methanol.

C13H11ClF3NO 289.69

Cl

NH2

OH

F3C

P-Nitrophenol

C6H5NO3 139.11 N+

O

-O

OH

(4RS)-6-Chloro-4-(cyclopropylethenyl)-1,4-dihydro-4-

(trifluoromethyl)-2H-3,1-Benzoxazin-2-one. (0.7620) (R-Isomer-50.0%)(S-Isomer-50.0%)

Recimic C14H11ClF3NO2 317.69

HN O

O

F F

F

Cl

6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline.

Quinoline analog C13H9ClF3N 271.67

N

FF

F

Cl

Enalapril maleate

(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] propanoic

acid Impurity-B

C15H21NO4 279.33

NH

OC2H5O

OH

O

(2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]

amino]propanoyl]pyrrolidine-2-carboxylic acid

Impurity-C

C18H24N2O5 ;

MW: 348.39

Ethyl (2S)-2-[(3S,8aS)-3-methyl-1,4-dioxooctahydropyrrolo [1,2-

a]pyrazin-2-yl]-4-phenylbutanoat Imp-D

C20H26N2O4 ;

MW: 358.43

O

O

N

N

O

O

H

(2S)-1-[(2S)-2-[[(1S)-3-Cyclohexyl-1-(ethoxycarbonyl)propyl]

amino]propanoyl]pyrrolidine-2-carboxylic acid

Impurity-H

C20H34N2O5 ;

MW: 382.49

N

OOH

O

NH

O

O

(2S)-2-[[(1S)-3-Cyclohexyl-1-(ethoxycarbonyl)propyl]amino]

propanoic acid Impurity-G

C15H27NO4 ;

MW: 285.38

NH

OC2H5O

OH

O

1H-Imidazole Impurity-I/ Imidazole

C3H4N2 Mol. Wt.: 68.08

N

NH

Escitalopram oxalate

1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-

benzofuran-5- carbonitrile –N-Oxide

C20H21FN2O2 340.39

O

N+-O F

N

4-[(4-dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-

(hydroxmethyl)benzonitrile

C20H23FN2O2 342.41

N

HO

HO F

N

1(R)-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-

isobenzofuran carbonitrile oxalate

C22H23FN2O5 414.43 O

NO

OH

O

OH

F

N

Ezetimibe

1-(3-Fluoro-phenyl)-3-[3-(4-fluoro-

phenyl)-3-hydroxy-propyl]-4-(4-

hydroxy-phenyl)-azetidin-2-one

Other isomer

C24H21F2NO3

409.15

N

O

OH

OH

F

F

1-(3-Fluoro-phenyl)-3-[3-(4-fluoro-

phenyl)-3-hydroxy-propyl]-4-(4-

hydroxy-phenyl)-azetidin-2-one

3-Fluro isomer

C24H21F2NO3

Mol. Wt.: 409.43

N

O

OH

F

OH

F

1-(3-Fluoro-phenyl)-4-(4-hydroxy-

phenyl)-3-(3-hydroxy-3-phenyl-

propyl)-azetidin-2-one

Desfluoro

impurity

C24H22FNO3

Mol. Wt.: 391.43

N

O

OH

OH

F

(3R,4S)-4-(4-(benzyloxy)phenyl)-1-(4-fluorophenyl)-3-[3-(4-

fluorophenyl)-3-oxopropyl]azetidin-2-one

C31H25F2NO3 497.53

NO

O

F

F

O

(3R,4S)-1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-(S)-hydroxypopyl]-

4-(4-benzyloxyphenyl)-2-azetidinone.

C31H27F2NO3 Mol. Wt.: 499.55

NF

OH

O

F

O

(2R,5S)-2-(4-Hydroxybenzyl)-N,5-bis(4-fluorophenyl)-5-hydroxypentanamide

C24H23F2NO3 411.44

O

HN

OH

F

F

OH

(3R,4S)-1-(4-fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-hydroxypopyl]-4-(4-

hydroxyphenyl)azetidin-2-one

C31H27F2NO3 Mol. Wt.: 499.55

NF

OH

O

F

O

(2R,3R,6S)-N,6-bis(4-fluorophenyl)-tetrahydro-2-(4-hydroxyphenyl)-

2H- pyran-3-carboxamide.

C24H21F2NO3 Mol. Wt.: 409.43

HN

F

O

F OH

O

Famotidine

3-[[[2-((diaminomethylene) amino) thiazoll-4-yl) methyl) thio)

propionamidine. HCl Impurity A

C8H15ClN6S2 Mol. Wt.: 294.83

S

NNC

H2N

H2NCH2SCH2CH2 C

NH

NH2.HCl

3.5 –Bis-[2[[[2-(diaminomethylene)amino]-4-

yl]methyl]thio] ethyl4H-1,2,4,6-thiatriazine-1,1dioxide

Impurity –B

C16H23N11O2S5 Mol. Wt.: 561.75 S

NNC

H2N

H2N

CH2SCH2CH2

NSO2

N

NH

CH2CH2SCH2

S

N N CNH2

NH2

N-(aminosulphonyl)-3-[[[2-[(diaminometylene)amino]-

thiazole-4-yl]methyl]thio]propanamide

Impurity C

C8H14N6O3S3 Mol. Wt.: 338.43

S

NNC

H2N

H2N

CH2SCH2CH2C

O

NHSO2NH2

3-[[[2-[(diaminometylene) amino] thiazol-4-yl] methyl] thio]

propionamide Impurity –D

C8H13N5OS2 Mol. Wt.: 259.35

S

NNC

H2N

H2N

CH2SCH2CH2C

O

NH2

Methyl 3-[[[2-[(diaminomethylene)amino]thiazol

e-4-yl]methyl]thio] propionate Impurity-J

C9H14N4O2S2 Mol. Wt.: 274.36

S

NNC

H2N

H2N

CH2SCH2CH2C

O

OCH3

3-[[[2-[diaminomethylene) amino] thiazol-4-yl]methyl]thio

]propionicacid Impurity-F

C8H12N4O2S2 Mol. Wt.: 260.34

S

NNC

H2N

H2N

CH2SCH2CH2COOH

3-[[[2-(guanidinothiazole-4-yl) methyl] sulfinyl]-N-2-

sulfamoylpropionamide (Degradent)-Sulfoxide

Impurity I

C8H15N7O3S3 Mol. Wt.: 353.44

S

NNC

H2N

H2N

S

ONH2

N

S

O

O

NH2

2,2'-[disulphanediylbis(methylenethiazo

le-4,2-diyl)diguanidine Impurity –E

C10H14N8S4 Mol. Wt.: 374.53

N

S

SN

NH2

H2NS N

S

N

NH2

NH2

(2-((diaminomethylene)amino)thiazol-

4-yl)methyl carbamimidothioate hydrochloride

Impurity –H

C6H11ClN6S2 Mol. Wt.: 266.77

S

NNCH2N

H2NCH2SC

NH

NH2.HCl

3,4dihydro-2H-[1,2,6]thiadiazine-5-amine1,1-dioxide

FAM-1A cyclic impurity

C3H7N3O2S Mol. Wt.: 149.17

S

HN

N NH2

O

O

Fenofibrate

[(4-chlorophenyl)(4-hydroxyphenyl)methanaone].

Related Compound A

C13H9ClO2 232.66

O

OHCl

(2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid

Related Compound B

C17H15ClO4 318.75

O

HO

O

O

Cl

Methyl 2-[4-(4-Chlorobenzoyl)phenoxy]-2-

methylpropanoate

Related Compound D

C18H17ClO4 332.78

O

O

O

O

Cl

(4-chlorophenyl)[4-(1 methylethoxy)phenyl]methanone

Related Compound F

C16H15ClO2 274.74

O

OCl

1-methylethyl-2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2-

methylpropanoate

Related Compound G

C24H27ClO6 446.92

O

HO

O

O

O

O

Cl

Fexofenadine hcl

2-(4-{4-[4-(Hydroxy-diphenyl-

methyl)-piperidin-1-yl]-butyryl}-

phenyl)-2-methyl-propionic acid

Related

compound-

A(Keto-acid)

C32H38ClNO4

536.10

.HCl

N

CH3

H3C

O

HO

COOH

2-(3-{1-Hydroxy-4-[4-(hydroxy-

diphenyl-methyl)-piperidin-1-yl]-

butyl}-phenyl)-2-methyl-propionic

acid

Related

compound-

B(Meta-isomer)

C32H40ClNO4

538.12

N

OH

OH

.HCl

H3C

CH3HO

O

2-(4-{4-[4-(Hydroxy-diphenyl-

methyl)-piperidin-1-yl]-butyryl}-

phenyl)-2-methyl-propionic acid

methyl ester

Keto Ester C33H40ClNO4

550.13

N

CH3

H3C

O

HO

.HCl

O

O

2-(4-Cyclopropylmethyl-phenyl)-2-

methyl-propionic acid

C14H16O3

232.28

CH3

H3C

OH

O

Fexofenadine HCL

Dehydrated

Impurity


CH3

HOOCCH3

OH

N

HCl

4-[4-(Hydroxy-diphenyl-methyl)-

piperidin-1-yl]-1-(4-isopropyl-

phenyl)-butan-1-ol

Decarboxylated

Impurity


.HCl

N

OH

HO

CH3

CH3

2-(4-{1-Hydroxy-4-[4-(hydroxy-

diphenyl-methyl)-piperidin-1-yl]-

butyl}-phenyl)-2-methyl-propionic

acid methyl ester

Hydroxy Ester C33H42ClNO4Mol. Wt.: 552.1

.HCl

N

CH3

H3C

HO

OH

O

O

Finasteride

(5α,17β)-N-(1,1-dimethyl ethyl)-3-oxo-4-aza androstane-17-

carboxamide

C23H38N2O2 374.56

NH

CH3

CH3

O HN

H3C

CH3

CH3

O

(5α,17β)-N-(cyclohexyl)-3-oxo-4-aza-5-androst-1-ene-17-

carboxamide.

C25H40N2O2 400.60

NH

CH3

CH3

O HN

O

(5α,17β)-Methyl-3-oxo-4-aza androst-1-ene-17-carboxylate

C20H29NO3 331.45

NH

CH3

CH3

OO

CH3

O

1,3-Dicyclohexyl urea

C13H24N2O 224.34

NH

O

NH

Fluoxetine hcl

Methyl-(3-phenyl-propyl)-amine Related

compound-B

/Dehydroxy

Impurity

C10H15NMol. Wt.: 149.23

NH

Methyl-[3-phenyl-3-(3-


amine

Impurity -C

C17H18F3NO

309.13

NH

OF3C

N-(3-Hydroxy-3-phenyl-propyl)-N-

methyl-acetamide

Impurity -D

C12H17NO2

207.13

NHO

O

N-Methyl-N-[3-phenyl-3-(4-


acetamide

Impurity -E C19H20F3NO2

351.14

NO

OF3C

3-Methylamino-1-phenyl-propan-1-

ol

Impurity-A

C10H15NOMol. Wt.: 165.23

HO NH

Glimepiride

Methyl[[4-[2-[[(3-ethyl-4-methyl-2-oxo-2,3 dihydro-1H-Pyrrole-1-

yl)carbonyl]amino]ethyl]phenyl]sulphonyl]

carbamate

EP-C 119018-30-3 C18H23N3O6S

409.46

NH2

O

O S

O

O NH

O

N

O

3-Ethyl-4-mehyl-2-oxo-N-[2-(4-sulphamoylphenyl)ethyl]-2,3-

dihydro-1H-Pyrrole-1-carboxamide

EP-B 119018-29-0 C16H21N3O4S

351.42 HN

N

O

O

S NH2

O

O

1-[[4-[2-[[(3-ethyl-4-methyl-2-oxo-2,3-dihydro-1H-Pyrrol-1-

yl)carbonyl]amino]ethyl]phenyl]sulphonyl]3-(cis-4-

methylcyclohexyl)urea.

EP-A (CIS-Isomer)

C24H34N4O5S 490.62

HN

O

HN

S

O

O

NH

O

N

O

Imatinibmesylate

N-(2-methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine-amine

C16H15N5 277.32

N

N

HN NH2N

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

methylbenzamide methanusulfonate

C25H25N5O4S 491.56

O

NH

NH

N

N

N

SO

OHO

Benzoic acid,4-[(4-methyl -1-piperazinyl)methyl]

dihydrochlorde.

C13H20Cl2N2O2 307.22

N

N

H3CO

OH

.2HCl

Irbisartan

1-pentanoylamino-cyclopentanecarboxylic acid *2’-(1H-tetrazol-5-yl)-biphenyl-4-yl-

methyl]amide.

USPRCA C25H30N6O2 446.54

O

HN

NH

NN

N HN

O

4-Bromomethyl-2’-cyanobiphenyl.

C14H10BrN 272.14

N

Br

2-propyl-3-**2’(1H-tetrazol-5-yl)*1,1’-biphenyl]-4-yl]methyl]-1,3-

diazaspiro[4,4]non-1-en-4-one.

C24H26N6O 414.50

N N

O

HN

N N

N

1-*(2’cyanobiphenyl-4-yl)mehyl]-2-

N-butyl-4-spirocyclopentane-2-imidazolin-5-one.

------

N-(triphenylmeyhyl)-5-*4’-(bromomethyl biphenyl)-2-

yl]tetrazole.

-------

2-N-butyl-4-spirocyclopentane-2-imidazolin-5-one hydrochloride

------

2-butyl-3-*2’-(1-triphenylmethyl-1H-tetrazol-5-yl)biphenyl-4-yl

methyl]-1,3-diazaspiro[4,4]non-1-en-4-one

C44H42N6O 670.84

N

N

O

N

NN

N

2-propyl-3-**2’-(1H-tetrazol-5-yl)*1,1’-biphenyl-4-yl methyl]-1,3-

diazaspiro[4,4]non-1-en-4-one

C24H26N6O 414.50

N N

O

HN

N N

N

1-*(2’-cyanobiphenyl-4-yl)methyl]-2-n-butyl-4-spirocyclopentane-2-

imidazolin-5-one

------

3-((2’(1-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-

tetrazol-5-yl) biphenyl -4-yl)methyl)-2-butyl-1,3-

diazaspiro[4.4]non-1-en-4-one

C38H37N10O 649.77

NN

ON

N N

N

HN

N

NN

3-((2’(2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)mrthyl)-2H-

tetrazol-5-yl) biphenyl -4-yl)methyl)-2-butyl-1,3-

diazaspiro[4.4]non-1-en-4-one.

C39H38N10O 662.79

N

N

O

N N

NN

HN

NN

N

Itraconazole

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-

1yl]phenyl]-2-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-

1-ylmehyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro3H-,2,4-

triazol-3-one.

EP-G C44H41Cl4N11O6 961.68

Cl Cl

O

O N

NN

N

N

N N N O

O

ON

NN

Cl Cl

O

4-[4-[4-[4-Methoxyphenyl)piperazin-1-

yl]phenyl]-2-[(IRS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one

EP -A 252964-68-4 C23H29N5O2

407.51

NN

N

O

N N O

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

EP-B C35H38Cl2N8O4 705.63

N

NN

O

NNOO

O

N

N N

Cl

Cl

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

triazol-1-ylmethyl)-1,3-dioxolan-4-yl]mehyoxy]phenyl]piperazin-

1yl]phenyl]-2-[(IRS)-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one

EP-E 252964-65-1 C35H38Cl2N8O4

705.63

NN

N

O

N N OO

O

NN

N

Cl

Cl


triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-

yl]phenyl]-2-(1-mehtylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one.

C34H36Cl2N8O4 691.61

N

N N

O NN

O

O

O

N

NN

ClCl


triazol-1-ylmehyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-

yl]phenyl]-2-(1-propyl)-2-,4-dihydro-3H-1,2,4-triazol-3-one.

EP-C 74855-91-7 C34H36Cl2N8O4

691.61 NN

N

O

N N OO

O

NN

N

Cl

Cl

Lamivudine

4-Amino-1-[(2R,3S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-

yl]pymidin-2(1H)-ONE S-Oxide.

-----

4-Amino-1-[(2R,3S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-

yl]pymidin-2(1H)-ONE S-Oxide.

--------

Lamotrigene

3-Amino-6-(2,3-dichloro-phenyl)-

6H-[1,2,4]triazin-5-one

Impurity -A /

Amide impurity

C9H6Cl2N4O

Mol. Wt.: 257.08

N

NN

O NH2

Cl

Cl

Lamotrigene

Impurity -B

C9H7Cl2N5Mol. Wt.: 256.09

H2N

NN

Cl

Cl

NH2N

2,3-Dichloro-benzoic acid

Impurity -E

C7H4Cl2O2Mol. Wt.: 191.01 Cl

Cl

OH

O

N-[5-Amino-6-(2,3-dichloro-

phenyl)-[1,2,4]triazin-3-yl]-2,3-

dichloro-benzamide

Impurity-F /

Dimer

C16H9Cl4N5OMol. Wt.: 429.09

O

NH

Cl

Cl

N

NN

Cl

Cl

NH2

Lansoprazole

2-(Chloromethyl-3-methyl-4-(2,2,2-trifluoethoxy)-pyridine.

239.62

N

H3C

Cl

O

CF3

1H-Benzimidazole-2-thiol. (3.5000) (99.3%)

150.20

N

HN

SH

(2[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-

pyridyl]methyl]sulfonyl]-1H-benizimidazole

sulfone 385.36

N

HN

S

O

O

N

H3C

O

CF3

2[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-

pyridinyl]methyl]thio]-1H-benzimidazole.

353.36

N

HN

S N

H3C

O

CF3


pyridinyl]methyl]sulfinyl]-1H-benizimidazole).

N-Oxide 385.36

N

HN

S N

H3C

O

CF3

O

O

Levetiracetam

(S)-N-(1-Amino-oxobutan-2-yl)-4-chlorobutanamide

USPRCA C8H15ClN2O2 206.67

O

NH

Cl

NH2

O

(S)-2-Amino-butanamide hydrochloride

USPRCB C4H11ClN2O 138.60 O

H2N

H2N

H Cl

(S)-2-(2-Oxopyrrolidin-1-yl)butanoic acid

LTC Acid C8H13NO3 171.19

O

HO

N

O

2-Hydroxy pyridine

C5H5NO 95.10

N

HO

(αS)- α-Ethyl-2-oxo-1-pyrrolidine acetic acid

171.20

N

O

NH2

CH3

O

( αR)- α-Ethyl-2-oxo-1-pyrrolidine acetamide

170.21

N

O

NH2

CH3

O

(R)-(+)- α-Methyl benzylamine

121.18

NH2

CH3

Levocetirizine hcl

Levofloxacin hemihydrate

8-Fluoro-3-methyl-9-(4-methyl-

piperazin-1-yl)-6-oxo-2,3-dihydro-

6H-1-oxa-3a-aza-phenalene-5-

carboxylic acid

Racemic mixture

C18H20FN3O4

361.14

N

O

OH

O

F

O

N

N

8,9-Difluoro-3-methyl-6-oxo-2,3-

dihydro-6H-1-oxa-3a-aza-

phenalene-5-carboxylic acid

Imp-A (Levo acid)

C13H9F2NO4

281.05

N

O

OH

O

F

O

F




carboxylic acid ethyl ester

Imp-B (Ethyl

ester)

)

C20H24FN3O4

389.18

N

O

OC2H5

O

F

O

N

N

8-Fluoro-3-methyl-6-oxo-9-

piperazin-1-yl-2,3-dihydro-6H-1-

oxa-3a-aza-phenalene-5-carboxylic

acid

IMP-C

(Piperazine)

C17H18FN3O4

347.13

N

O

OH

O

F

O

N

HN




carboxylic acid

N-Oxide Impurity

C18H20FN3O5

377.14

N

O

OH

O

F

O

N

N

O


piperazin-1-yl)-2,3-dihydro-1-oxa-

3a-aza-phenalen-6-one

Decarboxylated

impurity

C17H20FN3O2

317.15

N

O

F

O

N

N




carboxylic acid

OTHER ISOMER C18H20FN3O4

361.14

N

O

OH

O

F

O

N

N

C18H20FN3O4

361.14

Lisinopril

Trifluoro acetyl L-lysine

C8H13F3N2O3 242.20

NH2N

O OH

O

F

F

F

(S)-1-Carboxy-3-phenylpropyl-L-lysine

C16H24N2O4 308.37

HN

NH2

O

OH

O

HO

4-Methyl benzene sulphonic acid.

7H8O3S 172.20 S

O

O

OH

(2S)-1-[(2S)-6-amino-2-[[(IR)-1-

carboxy-3-phenylpropyl]amino]hexanoyl]pyrr

olidine-2-carboxylic acid

------

(R,S)-2-Amino-4-phenylbutanoic acid

C10H13NO2 179.22

O

OH

H2N

Losartan potassium

4’-[(2-Butyl-4-chloro-5-(hydroxymethyl)-1H-Imidazol-1-

yl)methyl]-*1,1’biphenyl+-2-carbonitrile.

C22H22ClN3O 379.88

N

N

N

OH

Cl

4’-[(2-butyl-4-chloro-5-formyl-1H-imidazol-1-yl)methyl]-*1,1’-

biphenyl]-2-carbonitrile

C22H20ClN3O 377.87

N

N

N

O

Cl

2-Butyl-4-chloro-1-**2’-(1H-tetrazol-5-yl)*1,1’-biphenyl]-4-yl]-methyl-1H-imidazole-5-carboxylic acid

C22H21ClN6O2 436.89

N

N

OOH

NH

NN

N

Cl

Meloxicam

4-Hydroxy-2-methyl-1,1-dioxo-1,2-

dihydro-1l6-benzo[e][1,2]thiazine-

3-carboxylic acid ethyl-(5-methyl-

thiazol-2-yl)-amide

Imp-C / Ethyl

Meloxicam

C16H17N3O4S2

379.07 NS

(E)

OH

O O

N

O N

S

4-Hydroxy-2-methyl-1,1-dioxo-1,2-

dihydro-1l6-benzo[e][1,2]thiazine-

3-carboxylic acid methyl-(5-methyl-

thiazol-2-yl)-amide

Imp-E / Methyl

Meloxicam

C15H15N3O4S2

365.05 NS

(E)

OH

O O

N

O N

S

4-Hydroxy-1,1-dioxo-1,2-dihydro-

1l6-benzo[e][1,2]thiazine-3-

carboxylic acid ethyl ester Impurity-G

C11H11NO5S

269.04 NHS

(E)

OH

O O

O

O

(1,1,3-Trioxo-1,3-dihydro-1l6-

benzo[d]isothiazol-2-yl)-acetic acid

ethyl ester Impurity-F

C11H11NO5S

269.04 SO O

N

O

O

O

5-Methyl-thiazol-2-ylamine

Imp-B / 2-amino-

5-methyl thiozole

C4H6N2S

114.03 N

SH2N

Memantine Hcl

1-acetamido-3,5-dimethyl adamantane.

C14H23NO 221.34

O

NH

Mesalamine

2-Hydroxy-3-nitro-benzoic acid

Impurity-R

C7H5NO5

183.12

OH

NO2

OH

O

4-Amino-benzenesulfonic acid

Impurity-O

C6H7NO3S

173.19 SO3H

H2N

2-Chloro-3-nitro-benzoic acid

Impurity-Q C7H4ClNO4 201.56

NO2

OH

O

Cl

2-Chloro-benzoic acid

Impurity-L

C7H5ClO2 156.57

OH

O

Cl

5-Amino-2-hydroxy-benzoic acid

Impurity-E

C7H7NO3

153.14 OH

O

OH

H2N

2-Hydroxy-5-phenylazo-benzoic

acid

Impurity-I

C13H10N2O3

242.23 OH

O

OH

NN

3,5-Diamino-2-hydroxy-benzoic

acid

Impurity-J C7H8N2O3

168.15 OH

O

OH

H2N

NH2

3-Amino-phenol Impurity-B

C6H7NO

109.13 OHH2N

3-Amino-benzoic acid

Impurity-D

C7H7NO2

137.14 OH

O

NH2

2-Hydroxy-benzoic acid

IMP-H

C7H6O3

138.12 OH

O

OH

2-Hydroxy-5-nitro-benzoic acid

IMP-N C7H5NO5

183.12 OH

O

OH

O2N

2-Chloro-5-nitro-benzoic acid

IMP-M/2-Chloro-

5-nitro

benzoic acid

C7H4ClNO4

201.56 OH

O

Cl

O2N

Metoprolol succinate

1-Ethylamino-3-[4-(2-methoxy-

ethyl)-phenoxy]-propan-2-ol Imurity A

C14H23NO3

253.17

OCH3

O

HO

HN

1-Chloro-3-[4-(2-methoxy-ethyl)-

phenoxy]-propan-2-ol Imurity B

C12H17ClO3

244.09

OCH3

O

HO

Cl

4-(2-Hydroxy-3-isopropylamino-

propoxy)-benzaldehyde

Imurity C

C13H19NO3

237.14 O

OH

HN

O

H

1-({2-Hydroxy-3-[4-(2-methoxy-

ethyl)-phenoxy]-propyl}-isopropyl-

amino)-3-[4-(2-methoxy-ethyl)-

phenoxy]-propan-2-ol

Imurity D

C27H41NO6

475.29 H3CO

O

OH

N

O

OCH3

HO

3-[4-(2-Methoxy-ethyl)-phenoxy]-

propane-1,2-diol

Metoprolol Diol

Impurity

C12H18O4

226.12

H3CO

O

OH

OH

Metoprolol Impurity

Epichlorohydrin

impurity

Montelukast

(1-{1-{3-[2-(7-Chloro-quinolin-2-yl)-ethyl]-phenyl}-3-[2-(1-hydroxy-1-

methyl-ethyl)-phenyl]-propylsulfanylmethyl}-cyclopropyl)-

acetic acid

Saturated analog

C35H38ClNO3S Mol. Wt.: 588.20

N

S

HO

OH

O

Cl

(1-{1-{3-[2-(7-Chloro-quinolin-2-yl)-vinyl]-phenyl}-3-[2-(1-hydroxy-1-methyl-ethyl)-phenyl]-propane-1-sulfinylmethyl}-cyclopropyl)-acetic

acid

Sulphoxide impurity


N

S

ClOH

OH

O

O

{1-[1-{3-[2-(7-Chloro-quinolin-2-yl)-vinyl]-phenyl}-3-(2-isopropenyl-phenyl)-propylsulfanylmethyl]-

cyclopropyl}-acetic acid

Styrine impurity


N

S

OH

O

Cl

(1-{1-{3-[2-(7-Chloro-quinolin-2-yl)-vinyl]-phenyl}-3-[2-(1-hydroxy-1-


acetonitrile

Nitrile impurity

C35H35ClN2OS Mol. Wt.: 567.18

N

S

CN

ClOH

[1-(3-(2-Acetyl-phenyl)-1-{3-[2-(7-chloro-quinolin-2-yl)-vinyl]-phenyl}-propylsulfanylmethyl)-cyclopropyl]-

acetic acid

Keto impurity


N

S

OH

O

ClO

(1-{1-{3-[2-(7-Chloro-quinolin-2-yl)-vinyl]-phenyl}-3-[2-(1-hydroxy-1-


acetic acid

Other Isomer


N

S

ClOH

OH

O

1-{3-[2-(7-Chloro-quinolin-2-yl)-vinyl]-phenyl}-3-[2-(1-hydroxy-1-

methyl-ethyl)-phenyl]-propan-1-ol

C29H28ClNO2 Mol. Wt.: 457.99

N

OH

ClOH

(1-Mercaptomethyl-cyclopropyl)-acetonitrile

C6H9NS 127.21

SH

CN

C6H9NS

127.21

2-(1-{1-{3-[2-(7-Chloro-quinolin-2-yl)-ethyl]-phenyl}-3-[2-(1-hydroxy-

1-methyl-ethyl)-phenyl]-propylsulfanylmethyl}-cyclopropyl)-

acetamide

Amide impurity

C35H39ClN2O2S Mol. Wt.: 587.21

N

S

HO

NH2

O

Cl

2-(1-((((R) -1-(3-(2-(7-Chloroquinolin-2-yl)ethyl)phenyl)-

3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)Sulfanyl)methyl)cy

clopropyl)acetic acid

Saturated imp C35H38ClNO3S Mol. Wt.: 588.20

S O

OH

NCl

HOCH3H3C

1-[[[(IR)-1-[3-[(IE)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-

hydroxy-1-ethylethyl)phenyl]propyl]thio]meth

yl]cyclopropane acetamide.

Amide C35H37ClN2O2S Mol. Wt.: 585.20

S O

NH2

NCl

HOCH3H3C

[1-[[[1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl)phenyl)-3-(2-(2-

hydroxpropan-2l)phenyl]propyl]sulfinyl]methyl]cy

clopropyl]acetic acid.

Sulfoxide impurity

C35H36ClNO4S

Mol. Wt.: 602.18 NCl

HO

SO

OH

O

1-[[[(IRS)-1-[3-[(IE)-2-(7-Chloroquinolin-2-

yl)ethenyl]phenyl]-3-[2-(prop-1-en-2-

yl)phenyl])propyl]sulfanyl]methyl]cyclopropyl]acetic acid

Recimate C36H38ClNO2S

Mol. Wt.: 584.21

S O

OH

NCl

H3CCH3H3C

S O

OH

NCl

H3CCH3H3C

2-[2-[3(S)-[3-[2-(7-Chloro-2-

quinolinyl)-ethenyl][phenyl]-3-hydroxypropyl]phenyl]-2-propyanol

Di ol- Imp

2(1-((((R)-1-(3-(2-(7-chloroquinolin-2-yl)ethyl)phenyl)-3-[2-(prop-1-en-

2-yydroxypropan-2-yl)phenyl)propyl)

sulfanyl)methyl)cyclopropyl)acetic acid

EP-B

Styrine

567.20

S O

OH

NCl

CH2H3C 1-[[[(IR)-1-[3-[(IZ)-2-(7-chloro-2-

quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-

methylethyl)phenyl]propyl]thio]methyl]cyclopropane acetic acid

Moxifloxacinhcl

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

hydrochloride

EP-A C20H21F2N3O3

389.16

N

O

OH

O

F

N

F

NH

1-Cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-

pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic

acid.

EP-B C22H27N3O5 413.20

N

O

OH

O

H3CO

N

OCH3

NH

1-cyclopropyl-8-ethoxy-6-fluoro-7-[(4aS,7aS)-octahydro-6H-

Pyrrolo[3,4-b]pyridi-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

EP-C C22H26FN3O4 415.19

N

O

OH

O

F

N

OC2H5

NH

1-Cyclopropyl -6-fluoro-8-methoxy-7-[(4aR,7aR)-octahydro-6H-

pyrrolo[3,4b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic

acid hydrochloride.

C21H24FN3O4 401.43

N

O

OH

O

F

N

OCH3

NH

1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4-

dihydroquinoline-3-carboxylic acid.

C14H11F2NO4 295.24

N

O

HO

O

O

F

F

1-Cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,7aS)-octahydro-6H-

pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihedroquinoline-3-carboxylic

acid

C20H22FN3O4 387.40

N

O

OH

O

F

N

OH

NH

Moxifloxacin HCl

8-methoxy

quinolonic acid

methyl ester

C22H26FN3O4

Mol. Wt.: 415.46 NH

N

F

OCH3

N

O

COOCH3

H

H

1-Cyclopropyl-6,7-difluoro-8-

methoxy-4-oxo-1,4-dihydro-

quinoline-3-carboxylic acid methyl

ester

8-methoxy

quinolonic acid

C15H13F2NO4

309.08

N

O

OCH3

O

F

OCH3

F


methoxy-4-oxo-1,4-dihydro-


8-hydroxy of

Moxifloxacin

C14H11F2NO4

295.07

N

O

OH

O

F

OCH3

F

1-Cyclopropyl-6-fluoro-8-hydroxy-

7-(octahydro-pyrrolo[3,4-b]pyridin-

6-yl)-4-oxo-1,4-dihydro-quinoline-

3-carboxylic acid

RR-isomer

C20H22FN3O4

387.16

N

O

OH

O

F

N

OH

NH

1-Cyclopropyl-6-fluoro-8-methoxy-

7-(octahydro-pyrrolo[3,4-b]pyridin-

6-yl)-4-oxo-1,4-dihydro-quinoline-

3-carboxylic acid

N-Methyl

piperazine imp

C21H24FN3O4

401.18

N

O

OH

O

F

N

OCH3

NH

H

H


7-(1-methyl-octahydro-pyrrolo[3,4-

b]pyridin-6-yl)-4-oxo-1,4-dihydro-


8-hydroxy of

Quinalonic acid

C22H26FN3O4

415.19

N

O

OH

O

F

N

OCH3

N


hydroxy-4-oxo-1,4-dihydro-


Fluoro Impurity

C13H9F2NO4

281.05

N

O

OH

O

F

OH

F


(octahydro-pyrrolo[3,4-b]pyridin-6-

yl)-4-oxo-1,4-dihydro-quinoline-3-

carboxylic acid

6,8-Dimethoxy

moxi.

C20H21F2N3O3

Mol. Wt.: 389.40

N

O

OH

O

F

N

F

NH

1-Cyclopropyl-6,8-dimethoxy-7-

(octahydro-pyrrolo[3,4-b]pyridin-6-

yl)-4-oxo-1,4-dihydro-quinoline-3-

carboxylic acid

8-Ethoxy Moxi.

C22H27N3O5

413.20

N

O

OH

O

H3CO

N

OCH3

NH

1-Cyclopropyl-8-ethoxy-6-fluoro-7-(octahydro-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydro-quinoline-3-

carboxylic acid

C22H26FN3O4

415.19

N

O

OH

O

F

N

OC2H5

NH

Naproxen

2-Acetyl-6-methoxy Naphthalene Impurity-A

C13H12O2 Mol. Wt.: 200.23 C

OCH3

H3CO

Methyl-2-(6-methoxy-2-naphthyl) propionate Naphthalene

Impurity-B

C15H16O3 Mol. Wt.: 244.29

H3CO

CH

CH3

COOCH3

Isopropyl-2-(6-methoxy-2-naphthyl) propionate Naphthalene

Impurity-C

C17H20O3 Mol. Wt.: 272.34

H3CO

CH

CH3

COO CH

CH3

CH3

1-(6-methoxy-2-napthyl) ethyl alcohol

Impurity-D

C13H14O2 Mol. Wt.: 202.25 CH

OH

CH3

H3CO

N-Octal –D-Glucamine Impurity-E

C14H31NO5 Mol. Wt.: 293.40

NH

HO

OH

OH

OH

HO

3-(6-Methoxy-naphthalen-2-yl)-3-methyl-oxirane-2-carboxylic acid

sec-butyl ester Epoxide Impurity

C19H22O4 Mol. Wt.: 314.38

H3CO

CH3

O

CH CO

CH CH3

CH2 CH3

O

2-(6-Methoxy-naphthalen-2-yl)-propionaldehyde

Aldehyde Impurity

C14H14O2 Mol. Wt.: 214.26

H3CO

CH3

CHO

2-(6-Methoxy-naphthalen-2-yl)-propionaldehydeoxime

Oxime Impurity

C14H15NO2 Mol. Wt.: 229.27

H3CO

CH3

CH N OH

Nebivolol hydrochloride

[2S*[IR*,5S*(S*)]]-alfa,alfa’-[Iminobis(methylene)]bis[6-fluoro-

3,4-dihydro-2H-1-benzopyran-2-methanol

C22H25F2NO4 405.44

NH

O

OH

FO

OH

F

[2S*[IR*,5R*(S*)]]-alfa,alfa’-[Iminobis(Methylene)]bis[6-fluoro-

3,4-dihydro-2H-1-benzopyran-2-methanol

C22H25F2NO4 405.44

NH

O

OH

FO

OH

F

(±)-[1S*(S*)]6-Flouro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran

C11H11FO2 194.20 O

OF

Nebivolol Peak-1

Nebivolol Peak-2

Nebivolol Di Steriomer

Norfloxacin

7-(2-Amino-ethylamino)-1-ethyl-

6,8-difluoro-4-oxo-1,4-dihydro-


Imp-B C14H15F2N3O3

311.11

N

(E)

F

HN

F

O

OH

O

NH2

1-Ethyl-6-fluoro-7-(4-formyl-



IMP-G C17H18FN3O4

347.13

N

(E)

F

N

O

OH

O

N

O

H

7-(4-Ethoxycarbonyl-piperazin-1-

yl)-1-ethyl-6-fluoro-4-oxo-1,4-


IMP-H C19H22FN3O5

391.15

N

(E)

F

N

O

OH

O

N

O

O

7-Chloro-1-ethyl-6-fluoro-4-oxo-

1,4-dihydro-quinoline-3-carboxylic

acid

C12H9ClFNO3

269.03

N

(E)

F

O

OH

O

Cl

6-Chloro-1-ethyl-4-oxo-7-piperazin-

1-yl-1,4-dihydro-quinoline-3-

carboxylic acid

Impurity-F

(chloro analogue)

C16H18ClN3O3

335.10

N

(E)

Cl

N

O

OH

O

HN

1-Ethyl-4-oxo-6,7-di-piperazin-1-yl-


acid

Imp-C/Dimer

C20H27N5O3

385.21

NN

O

OH

O

HN

N

HN

7-Chloro-1-ethyl-4-oxo-6-piperazin-

1-yl-1,4-dihydro-quinoline-3-

carboxylic acid

Imp-E C16H18ClN3O3

335.10

N

O

OH

O

N

Cl

HN

Ofloxacin




carboxylic acid ethyl ester

Ethylester C20H24FN3O4

389.18

N

O

OC2H5

O

F

O

N

N

3-Methyl-9-(4-methyl-piperazin-1-

yl)-6-oxo-2,3-dihydro-6H-1-oxa-3a-

aza-phenalene-5-carboxylic acid

Desfluoro

impurity

C18H21N3O4

343.15

N

O

OH

O

O

N

N

Olanzapin

2-(2-Amino-phenylamino)-5-methyl-thiophene-3-carbonitrile

C12H11N3S Mol. Wt.: 229.30

NH

NH2

S

CN

4-(2-Methyl-4H-3-thia-4,9-diaza-benzo[f]azulen-10-yl)-piperazine-1-

carbaldehyde Formyl impurity

C17H18N4OS Mol. Wt.: 326.42

NH

N

S

N N

H

O

2-Methyl-10-piperazin-1-yl-4H-3-thia-4,9-diaza-benzo[f]azulene

Desmethyl impurity

C16H18N4S Mol. Wt.: 298.41

NH

N

S

N NH

2-Methyl-10-(4-methyl-piperazin-1-yl)-4H-3-thia-4,9-diaza-

benzo[f]azulene N - Oxide

C17H20N4OS Mol. Wt.: 328.43

NH

N

S

N N

O

1-[4-(2-Methyl-4H-3-thia-4,9-diaza-benzo[f]azulen-10-yl)-piperazin-1-

yl]-ethanone Acetyl

C18H20N4OS Mol. Wt.: 340.44

NH

N

S

N N

O

2-Methyl-10-[4-(2-methyl-4H-3-thia-4,9-diaza-benzo[f]azulen-10-yl)-piperazin-1-yl]-4H-1-thia-4,9-

diaza-benzo[f]azulene

dimer

C28H26N6S2 Mol. Wt.: 510.68

NH

N

S

N N NHN

S

CH3

1-Chloromethyl-1-methyl-4-(4H-3-thia-4,9-diaza-benzo[f]azulen-10-

yl)-piperazin-1-ium Quaternary salt

C17H20ClN4S+ Mol. Wt.: 347.88

NH

N

S

N NCl

2-Methyl-4H-3-thia-4,9-diaza-benzo[f]azulen-10-ylamine

C12H12ClN3S Mol. Wt.: 265.76

NH

N

S

NH2.HCl

2-Methyl-4,9-dihydro-3-thia-4,9-diaza-benzo[f]azulen-10-one

DEG PIN

C12H10N2OS Mol. Wt.: 230.29

NH

HN

S

O

4-Amino-2-methyl-10H-thieno-[2,3-

b][1,5]benzodiazapine. -----

2-Methyl-4-(1-piperazinyl)-10H-thieno-[2,3-b][1,5]benzodiazepine.

C16H18N4S 298.41

NH

N

S

N

NH

2-(1,2-phenylenediamino)-5-

methyl-thiophene-3-carbonitrile. -------

2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-

4-one.

USP-B C12H10N2OS 230.29

HN

NHS

O

2-Methyl-4-(4-ethyl-1-piperazinyl)-10H-thieno[2,3-

b][1,5]benzodiazepine.

Ethyl Derivative C18H22N4S 326.46

NH

N

S

N

N

2-(2-Nitroaniline)-5-methyl-thiophene-3-carbonitrile

USP-A ------

2-Amino-5-methyl-thiophene-3-carbonitrile

C6H6N2S 138.19

S

N

NH2

1-Flouro-2-nitro benzene.

C6H4FNO2 141.10

N+

O

O-F

Olmesartan medoxomil

(5-methyl-2-oxo-1,3-dioxol-4-yl)mehtyl-4-(2-hydroxy-propan-2-

yl)-2-propyl-1-**2’-(1-triphenylmethyl-1H-tetrazole-5-

yl)biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylate

EP-D C48H43N6O6 799.89

N

N

O

O-N

N N

N

HO

O

O

O

Tri phenyl methanol

C19H16O 260.33

OH

4-(2-Hydroxypropan-2-yl)-2-propyl-1-**2’-(1H-tetrazole-5-yl)-biphenyl-

4-yl]methyl]-1H-Imidazole-5-carboxylic acid

EP-A C24H26N6O3 446.50

N

N

OHO

NH

NN

N HO

4-[1-Hydroxy-1-methylethyl]-2-

propyl-1-**2’-[1(triphenylmethyl)-1H-Tetrazol-5-yl+1,1’-biphenyl-4-yl-

methyl]-1H-imidazole-5-carboxylicacid(5-methyl-2-oxo-1,3-

dioxal-4-yl)methyl ester

4-[1-Hydroxy-1-methylethyl]-2-propyl-1-**2’-1H-tetrazole-5-yl+1,1’-

biphenyl-4-yl-methyl]- 1H-Imidazole-5-carboxlylic acid

Omeprazole

5-Methoxy-1H-benzoimidazole-2-thiol

Impurity-A

C8H8N2OS Mol. Wt.: 180.23

N

HN

SH

O

2-(3,5-Dimethyl-pyridin-2-ylmethanesulfinyl)-5-methoxy-1H-

benzoimidazole Impurity-B

C16H17N3O2S Mol. Wt.: 315.39

N

HN

O

S

O

N

5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-

ylmethylsulfanyl)-1H-benzoimidazole

Impurity-C

C17H19N3O2S Mol. Wt.: 329.42

N

HN

S N

O

O

5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-

ylmethanesulfonyl)-1H-benzoimidazole

Impurity-D

C17H19N3O4S Mol. Wt.: 361.42

N

HN

S

O

ON O

O

5-Methoxy-2-(4-methoxy-3,5-dimethyl-1-oxy-pyridin-2-

ylmethanesulfinyl)-1H-benzoimidazole

Impurity-E

C17H19N3O4S Mol. Wt.: 361.42

N+S

ON

HN

O

O

-O

7-Methoxy-1,3-dimethyl-10-thioxo-10H-4a,5,9b-triaza-indeno[2,1-

a]inden-2-one Impurity-F

C16H13N3O2S Mol. Wt.: 311.36

N

N

NO

S

O

8-Methoxy-1,3-dimethyl-10-thioxo-10H-4a,5,9b-triaza-indeno[2,1-

a]inden-2-one Impurity-G

C16H13N3O2S Mol. Wt.: 311.36

N

N

NO

S O

2-(4-Chloro-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-5-methoxy-1H-

benzoimidazole Impurity-H


N

HN

O

S

O

N

Cl

2-(4-Chloro-3,5-dimethyl-pyridin-2-ylmethanesulfonyl)-5-methoxy-1H-

benzoimidazole Impurity-I


N

HN

O

S

O

N

Cl

O

O Ondansetron

3-Dimethylaminomethyl-9-methyl-1,2,3,9-tetrahydro-carbazol-4-one

Impurity-A

C16H20N2O Mol. Wt.: 256.34

N

O N

9-Methyl-1,2,3,9-tetrahydro-carbazol-4-one

Impurity-C

C13H13NO Mol. Wt.: 199.25

N

O

9-Methyl-3-methylene-1,2,3,9-tetrahydro-carbazol-4-one

Impurity-D/Methylene

impurity

C14H13NO Mol. Wt.: 211.26

N

O

1H-Imidazole Impurity-E/

C3H4N2 Mol. Wt.: 68.08

HNN

2-Methyl-1H-imidazole Impurity-F/

C4H6N2 Mol. Wt.: 82.10

HNN

3-Imidazol-1-ylmethyl-3,9-dimethyl-1,2,3,9-tetrahydro-

carbazol-4-one Impurity-G/

C18H19N3O Mol. Wt.: 293.36

N

O NN

3-Imidazol-1-ylmethyl-9-methyl-1,2,3,9-tetrahydro-carbazol-4-one

Desmethyl impurity

C17H17N3O Mol. Wt.: 279.34

N

O NN

Oseltamivir phosphate

(5-methyl-2-oxo-1,3-dioxol-4-yl)mehtyl-4-(2-hydroxy-propan-2-

yl)-2-propyl-1-**2’-(1-triphenylmethyl-1H-tetrazole-5-

yl)biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylate.

EP-D C48H43N6O6 799.89

N

N

O

O-N

N N

N

HO

O

O

O

Tri phenyl methanol

C19H16O 260.33

OH

4-(2-Hydroxypropan-2-yl)-2-propyl-1-**2’-(1H-tetrazole-5-yl)-biphenyl-

4-yl]methyl]-1H-Imidazole-5-carboxylic acid

EP-A C24H26N6O3 446.50

N

N

OHO

NH

NN

N HO

4-[1-Hydroxy-1-methylethyl]-2-

propyl-1-**2’-[1(triphenylmethyl)-1H-Tetrazol-5-yl+1,1’-biphenyl-4-yl-

---------

methyl]-1H-imidazole-5-carboxylicacid(5-methyl-2-oxo-1,3-

dioxal-4-yl)methyl ester

4-[1-Hydroxy-1-methylethyl]-2-propyl-1-**2’-1H-tetrazole-5-yl+1,1’-

biphenyl-4-yl-methyl]- 1H-Imidazole-5-carboxlylic acid

------

Pantaprozole

5-(difluoromethoxy)-1H-benzimidazole-2-thiol.

EP-C C8H6F2N2OS 216.21

N

HN

HS

O

F

F

2-(Chloromethyl)-3,4-dimethoxy-pyridine hydrochloride.

224.08

N

OMeOMe

CH2Cl

. HCl

5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-

yl)methyl]sulphonyl]-1H-Benzimidazole.

EP-A

C17H16F2N2O6S Mol. Wt.: 414.38

OF

F

N

HN

S

O

CH3 O CH3

O

O

O

5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-

yl]methyl]sulphanyl]-1H-benzimidazole.

EP-B C17H16F2N2O5S Mol. Wt.: 398.38

OF

F

N

HN

S

O

CH3 O CH3

O

O

2-Chloromethyl-3,4-dimethoxy-pyridine

Chloro impurity

C8H10ClNO2 Mol. Wt.: 187.62

N

O

Cl O

5-Difluoromethoxy-1H-benzoimidazole-2-thiol

Benzimidazole

C8H6F2N2OS Mol. Wt.: 216.21

HN

NSH

OF

F

6-Difluoromethoxy-1-(3,4-dimethoxy-pyridin-2-ylmethyl)-2-

(3,4-dimethoxy-pyridin-2-ylmethylsulfanyl)-1H-

benzoimidazole

N-alkylated

C24H24F2N4O5S Mol. Wt.: 518.53

N

N

S

N

OOO

F

F

N

O

O

6-Difluoromethoxy-2-(3,4-dimethoxy-pyridin-2-ylmethylsulfanyl)-1H-

benzoimidazolePantaprozole

Sulphide imp

C16H15F2N3O3S Mol. Wt.: 367.37 H

N

NS N

OO

O

F

F

5-Difluoromethoxy-2-(3,4-dimethoxy-1-oxy-pyridin-2-

ylmethanesulfinyl)-1H-benzoimidazole

N-oxide

C16H15F2N3O5S Mol. Wt.: 399.37

N

NH

S

O

N

OO

O

F

F

O

5-Difluoromethoxy-2-(3,4-dimethoxy-pyridin-2-ylmethylsulfanyl)-1H-

benzoimidazole

N-oxide sulphide

C16H15F2N3O4S Mol. Wt.: 383.37

N

NH

S N

OO

O

F

F

O

5-Difluoromethoxy-2-(3,4-dimethoxy-pyridin-2-

ylmethanesulfonyl)-1H-benzoimidazole

Sulphone imp

C16H15F2N3O5S Mol. Wt.: 399.37

N

NH

S

ON O

O

O

F

F O


ylmethanesulfinyl)-1-methyl-1H-benzoimidazole

N-Methyl impurity/Impuirt

y-D

C17H17F2N3O4S Mol. Wt.: 397.40

N

NS

O

N

OO

O

F

F


ylmethanesulfinyl)-1-methyl-2,3-dihydro-1H-benzoimidazole

N-Methyl impurity/Impuirt

y-F

C17H19F2N3O4S Mol. Wt.: 399.41

N

NH

S

O

N

OO

O

F

F

Paroxetenehcl

4-(4-Fluoro-phenyl)-1-methyl-

1,2,3,6-tetrahydro-pyridine

Imp-E C12H14FN

191.11

N F

3-(Benzo[1,3]dioxol-5-

yloxymethyl)-4-(4-fluoro-phenyl)-1-

methyl-piperidine

C20H22FNO3

343.16

N

F

O

O

O


yloxymethyl)-4-(4-fluoro-phenyl)-1-

methyl-piperidine

RC-F C20H22FNO3

343.16

N

F

O

O

O


yloxymethyl)-4-(4-fluoro-phenyl)-

piperidine-1-carboxylic acid methyl

ester

C21H22FNO5

387.15 N

F

O

O

O

OCH3O


yloxymethyl)-4-(4-fluoro-phenyl)-

piperidine

RC-C C19H21ClFNO3

365.12

HN

F

O

O

O

.HCl

Pioglitazone hydrochloride

5-[[4-2-(5-Ethyl-2-pyridyl)ethoxy]phenyl]methyl]-2-

imino-thiazolidine-4-one

C19H21N3O2S 355.45 S

N

O

NH

O

N

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

C34H35N3O4S 581.72

S

NO

O

O

NO

N

Pramiprexoledihydrochloride

(S)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole

C7H11N3S 169.25

S

N

NH2H2N

(S)-2-Amino-6-propionamido tetrahydro benzothiazole.

C10H15N3OS 225.31 S

NH

O

HN

H2N

(R)-4,5,6,7-tetrahydro-N6-propyl-

2,6-benzothiazolediamine.

C10H17N3S 211.33

SN

NH2

NH2

Pregabalin

(R)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid.

C9H17NO3 187.24

O

HO

O

H2N

(R)-3-(Aminomehtyl)-5-methyhexanoic acid.

C8H17NO2 159.23 O

OH

H2N

Q.acid

7-Chloro-1-cyclopropyl-6-methoxy-

4-oxo-1,4-dihydro-quinoline-3-

carboxylic acid

Methoxy

impurity

C14H12ClNO4

Mol. Wt.: 293.70

N

H3CO

Cl

O

OH

O

6,7-Dichloro-1-cyclopropyl-4-oxo-


acid

Chloro analog

C13H9Cl2NO3

Mol. Wt.: 298.12

N

Cl

Cl

O

OH

O



carboxylic acid methyl ester

Methyl ester

C14H11ClFNO3

Mol. Wt.: 295.69

N

Cl

F

O

OCH3

O

7-Chloro-1-cyclopropyl-4-oxo-1,4-


Des fluoro

impurity

C13H10ClNO3

Mol. Wt.: 263.68

NCl

O

OH

O



carboxylic acid

C13H9ClFNO3

Mol. Wt.: 281.67

NF

O

OH

O

Cl


4-oxo-1,4-dihydro-quinoline-3-

carboxylic acid

C14H12FNO4

Mol. Wt.: 277.25

NF

O

OH

O

H3CO

Quetipinehemifumarate

Dibenzo-(1,4)-thiazepine-11(10H)-

one

EP-G

227.28

S

HN

O

11-(1-piperazinyl) dibenzo-(1,4)-

thiazepine

EP-B 295.41

S

NN

NH

2-(4-Dibenzo[b,f]-[1,4]-thiazepine-

11-yl-1-piperazineyl)ethanol.

S-OXIDE 399.51

S

NN

N

O OH

O

2-[2-(4-Dibenzo[b,f]-[1,4]thiazepin-

11-yl-1-piperazinyl)ethoxy]ethanol

N-oxide

N-OXIDE 399.51

S

NN

N

O OH

O

11-(1-piperazinyl)dibenzo-(1,4)-thiazepine

C17H17N3S 295.40

S

N

N

HN

2-(4-Dibenzo[b,f]-[1,4]-thiazepine-

11-yl-1-piperazinyl)ethanol hemifumarate

--------

Rabeprazole sodium

2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]mehtyl]thio]-

1H-benzimidazole

C18H21N3O2S 343.44

N

HN

S

N

O

O

2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]mehtyl]]-1H-

benzimidazole.

C18H21N3O2 311.38 N

NH N

O

O

4-(3-Methoxypropoxy)-3-methyl-2-chloromethyl-

pyridine,hydrochloride

C11H17Cl2NO2 266.16

NCl

O

O

H

Cl

1H-benzimidazole-2-thiol

C7H6N2S 150.20

N

HN

HS

Raloxifene hydrochloride

Methanone,[6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-

yl][4-[2-(1-oxido-1- piperidinyl)ethoxy]phenyl].

N -Oxide C28H28NO5S- 490.59

O

O

NH-O

S

HO

OH

(RFHRC01)

Ramipril

2-(5-Methyl-4,7-dioxo-decahydro-3b,6-diaza-cyclopenta[a]inden-6-

yl)-4-phenyl-butyric acid ethyl ester Impurity-D

C23H30N2O4 Mol. Wt.: 398.50

N

C2H5O O

NH3C

O

O H

H

1-[2-(1-Carboxy-3-phenyl-propylamino)-propionyl]-

octahydro-cyclopenta[b]pyrrole-2-carboxylic acid

Impurity-E

C21H28N2O5 Mol. Wt.: 388.46

NH

HO O

N

O H

HHOOC

2-(1-Carboxy-ethylamino)-4-phenyl-butyric acid ethyl ester

Impurity-F/ECPP alanine

C15H21NO4 Mol. Wt.: 279.33

NH

C2H5O O

OH

O

Ramipril Impurity-

G/Toluene

2-[4-(1-Ethoxycarbonyl-3-phenyl-propyl)-2,5-dimethyl-3,6-dioxo-piperazin-1-yl]-4-phenyl-butyric

acid ethyl ester

Impurity-O

C30H38N2O6 Mol. Wt.: 522.63

N

C2H5O O

NO

O

OC2H5

O

1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-

octahydro-cyclopenta[b]pyrrole-2-carboxylic acid

Impuirty-N

C23H32N2O5 Mol. Wt.: 416.51

NH

C2H5O O

NH3C

O H

HHOOC

Octahydro-cyclopenta[b]pyrrole-2-carboxylic acid benzyl ester

RRR Isomer

C15H19NO2 Mol. Wt.: 245.32

HN

H

H

OPh

O

2-(1-Carboxy-ethylamino)-4-phenyl-butyric acid ethyl ester

(R,R)-Isomer

C15H21NO4 Mol. Wt.: 279.33

NH

C2H5O O

OHH3C

O

1-[2-(3-Cyclohexyl-1-ethoxycarbonyl-propylamino)-

propionyl]-octahydro-cyclopenta[b]pyrrole-2-carboxylic

acid

Impurity-C

C23H38N2O5 Mol. Wt.: 422.56

NH

C2H5O O

NH3C

O H

HHOOC

Benzyl(cis,endo)-octahydrocyclopenta[b]pyrrole-2(S)-carboxylate hydrochloride

C15H19ClNO2- 280.77

N

O

O-

H

Cl

H

H

N-[1(S)-Carboethoxy-3-phenylpropyl]-(S)-alanine

C15H21NO4 279.33

NH

O

OH

OO

(2S,3aS,6aS)-1[(S)-2-[[(S)-1-carboxy-3-

phenylpropyl]amino]propanoyl]octahydro cyclopenta[b]pyrrole-2-

carboxylic acid.

EP-E Di Acid

C21H28N2O5 388.46

N

O

OH

O

NH

OOH

H

H

Ranitidine

5-[[(2-aminoethyl) thio] methyl]-NN’-dimethyl-2-furanmethanamine

hemifumarate Impurity-A

C14H21N2O5S- Mol. Wt.: 329.39

ON

CH2SCH2CH2NH2C

C

COO-H

HOOC H

N, N’-Bis [2-[[[5-[(dimethylamino) methyl]-2- furanyl] methyl] thio]

ethyl] -2-nitro-1,1-ethanediamine (RMT)

Impurity-B

C20H39N3O3S Mol. Wt.: 401.61

ON S NH

2

CH

CHNO2

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

–N’-methyl-2-nitro-1, 1-ethenediamine.

Impurity-C

C13H22N4O4S Mol. Wt.: 330.40

ON

CH2S NHC

CHNO2

NHCH3

O

5-[(dimethylamino) methyl]-2-furanmethanol (RI-I)

Impurity-D

C8H13NO2 Mol. Wt.: 155.19

ON OH

5, 6-dihydro-3-methylamino-2H-1,4-thiazin-2-one oxime

Impurity-E

C5H9N3OS Mol. Wt.: 159.21

S

N NHCH3

NOH

N-methyl-2-nitro Acetamide (NAT) Impurity-F

C3H6N2O3 Mol. Wt.: 118.09

O

CNH

CH3O2N

N-[2-[[[5-[(dimethylamino) methyl]-2-furanyl] methyl] thio] ethyl]-2-

nitro Acetamide. (N Impurity-G

C12H19N3O4S Mol. Wt.: 301.36

ON S NHC

O

CH2NO2

Formaldehyde Adduct Impurity-I

C27H44N8O6S2 Mol. Wt.: 640.82

S NH

O2N

NHCH3

CH2

H3CHN NH

SO N

CH3

CH3

NO2

ON

H3C

H3C

1,1’-N-[Methylene bis(sulphanediyllethlene)+bis(N’-methyl-2-nitroethenamine-1,1-

diamine)

Impurity-J

C11H22N6O4S2 Mol. Wt.: 366.46

N

CHNO2H3C

HNH

S S NH

CHNO2NH

CH3

N-methyl,1-methyl thio-2-nitro ethenamine

Impurity-K

C3H5N2O2S Mol. Wt.: 133.15

CHNO2

C

SNHCH3

N,N-dimethyl-1-(5-(((2-((1-

(methylamino)-2-nitrovinyl)amino)ethyl)thio)methyl)

furan-2-yl)methanamine oxide

Ran-N-Oxide

C13H22N4O4S Mol. Wt.: 330.40

NHCH3O

N S NH

CHNO2

O

1,1-Bis-methylsulshonyl-2-nitro-ethane

BDMT

C4H7NO2S2 Mol. Wt.: 165.23

CHNO2

S S Repaglinide

2-Ethoxy-4-{[3-methyl-1-(2-

piperidin-1-yl-phenyl)-

butylcarbamoyl]-methyl}-benzoic

acid

IMP-E C27H36N2O4

Mol. Wt.: 452.59

NH

N

O OH

O

O




acid ethyl ester

C29H40N2O4

Mol. Wt.: 480.64

NH

N

O O

O

O

Repaglinide

Imp-A C23H37N3O5

Mol. Wt.: 435.56

NH2

N

OH

O

NH

O

O

OH

4-Carboxymethyl-2-ethoxy-benzoic

acid ethyl ester

Imp-B C13H16O5

Mol. Wt.: 252.26 HO

O

O

O

O


acid

Imp-A C11H12O5

Mol. Wt.: 224.21 HO

O

O

OH

O

3-Methyl-1-(2-piperidin-1-yl-

phenyl)-butylamine

Imp-C C16H26N2

Mol. Wt.: 246.39

N

NH2

2-Ethoxy-4-({3-methyl-1-[2-

(methyl-propyl-amino)-phenyl]-

butylcarbamoyl}-methyl)-benzoic

acid ethyl ester

Imp-D C29H40N2O4

Mol. Wt.: 480.64

N

NH

O

O

O

O




acid ethyl ester

C29H40N2O4

Mol. Wt.: 480.64

N

NH

CH2

O

O

O

O




acid

C27H36N2O4

Mol. Wt.: 452.59

N

NH

O

O

OH

O


acid methyl ester

Methyl ester

Impurity

C12H14O5

Mol. Wt.: 238.24

HO

O

O

O

O

2-Ethoxy-4-{[2-phenyl-1-(2-


ethylcarbamoyl]-methyl}-benzoic

acid

Imp-C C30H34N2O4

Mol. Wt.: 486.60

N

NH

O

O

OH

O

(3-ethoxy-4-ethoxycarbonyl-phenyl acetic acid)

USP-B

EP-B

252.26

O

O

CH3

O CH3HO

O

(S)-3-Methyl-1-[2-(1-piperidinyl)phenyl]butylamine

246.40

N

H3C CH3

NH2

H

Ethyl 2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(piperidin-1-

yl)phenyl]butyl]amino-2-oxoethyl]benzoate.

RC-D 480.64

N

H3C CH3

NH

HO

O

CH3

O CH3

O

(1S)-3-Methyl-1-[2-1-(piperidinyl)phenyl]

butylamine, N-acetyl-L-glutamate salt

USP-A 435.56

N

H3C CH3

NH2

HNH

CH3

HO

O

HOO

O

.

4-(carboxymethyl)-2-ethoxybenzoic acid

EP-A C11H12O5 224.21

O

HO

O

O

HO

Rilpivirine hydrochloride

4-Cyanoaniline

C7H6N2 118.14 NH2N

(E)-3-(4-(2-(4-Cyanophenylamino) pyrimidin-4-ylamino)-3,5-

dimehtylphenyl) acrylonitrile

C22H18N6 Mol. Wt.: 366.42

N

NH

N

N

NHN

(E)-3-(4-(2-(4-Cyanophenylamino) pyrimidin-4-ylamino)-3,5-

dimehtylphenyl) acrylamide.

C22H20N6O 384.43

O

NH2

NH

N

N

NHN

Ritonavir

γ-(S)-Amino α-(1S)-(thiazolylmethyloxycarbonyl)-

amino-(2-phenylethyl)-(S)-benzene butnol.

N-[[(methyl[[2-(1-methylethyl)-4-thizoyl]mehtyl]amino]carbonyl]-L-

valine

(2S)-N-[(1S,2S,4S)-1-benzyl-2-hydroxy-4-[[(2S)-3-methyl-2-

[[methyl[[2-(1- methylethyl)thiazol-4-

l]mehtyl]carbamoyl]amino]butanoyl]amino]-5-phenylpentyl]-3-methyl-

2-[[methyl[[2-(1-methylethyl)thiazol-4-

yl]methyl]carbamoyl]amino]butanamide

Rivastigmine

Ethyl-methyl-carbamic acid 3-(1-

methylamino-ethyl)-phenyl ester

Desmethyl

Rivastigmine

C13H20N2O2

Mol. Wt.: 236.31 NHON

O

Dimethyl-carbamic acid 3-(1-

dimethylamino-ethyl)-phenyl ester;

compound with methane

Dimethyl

Rivastigmine

C13H20N2O2

Mol. Wt.: 236.31 NON

O(R)

Rivastigmine Undesired Isomer

C14H22N2O2

Mol. Wt.: 250.34 NON

O(R)

Rivastigmine Diparatolyl D-

Tartaric acid

C19H16O8

Mol. Wt.: 372.33

(S)

O

O

OH

O

O

HO

O

O

(S)

Rizatriptan benzoate

N,N-Dimethyl-5-(1H-1,2,4-triazol-1-yl-methyl)-1H-indole-3-ethanamine

N-oxide

C15H19N5O 285.34 NH+

N

NN

N

-O

2-[5-(1H-1,2,4-triazol-1-yl-methyl)-1H-Indole-3-yl]ethanol

C13H14N4O 242.28

NH

NN

N

HO

Ropinrole

3-[2-(2-Dipropylamino-ethyl)-6-nitro-phenyl]-2-oxo-propionic acid

C17H24N2O5 Mol. Wt.: 336.38

NO2

OO

OH

N

3-[2-(2-Dipropylamino-ethyl)-6-nitro-phenyl]-2-oxo-propionic acid

ethyl ester

C19H28N2O5 Mol. Wt.: 364.44

NO2

OO

O

N

4-(2-Dipropylamino-ethyl)-1-hydroxy-1,3-dihydro-indol-2-one

C16H24N2O2 Mol. Wt.: 276.37

N

NO

OH

4-(2-Dipropylamino-ethyl)-1H-indole-2,3-dione

3-Oxo Impurity

C16H22N2O2 Mol. Wt.: 274.36

N

NH

O

O

[2-(2-Dipropylamino-ethyl)-6-nitro-phenyl]-acetic acid

C16H24N2O4 Mol. Wt.: 308.37

N

O

OHNO2

4-(2-Propylamino-ethyl)-1,3-dihydro-indol-2-one

Despropyl impurity

C13H18N2O Mol. Wt.: 218.29

NH

NH

O

[2-(2-Methyl-3-nitro-phenyl)-ethyl]-dipropyl-amine

C15H24N2O2 Mol. Wt.: 264.36

N

NO2 Rosiglitazone maleate

IMPURITY-I

Maleic acid

impurity

IMPURITY-II Dehydro impurity

IMPURITY-III

Rosuvastatin calcium

(R)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl methyl

sulfonamido)pyrimidin-5-yl)-3-hydroxy- 5-oxohept-6-enoic

acid

C22H26FN3O6S 479.52

O

OH

O OH

N

N

S

O

O

N

F

(3R, 5S, E)-mehtyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-

methyl methyl sulfonamido) pyrimidin-5- yl)-3,5-dihydroxyhept-

6-enoate.

C23H30FN3O6S 495.56

O

O

OH OH

N

N

S

O

O

N

F

Saquinavirmesilate

(2R)-N1-[(IS,2R)-1-benzyl-3-

[(3S,4aS,8aS)-3-[(1,1-dimethylethyl)carbamoyl]octa hydroisoquinolin-2(1H)-yl]-2-

hydroxypropyl]-2-[(quinolin-2-ylcarbonyl)amino]butanediamide

EP-D C38H50N6O5 670.84

NHN

ONH

O

N

H

H2NO

H

H OH

H

H

H

ONH

CH3

CH3

CH3

Ethyl(2S)-4-amino-4-oxo-2-[(quinolin-2-

ylcarbonyl)amino]butanoate

EP-B C16H17N3O4 315.32

O

O

HN

O

N O

NH2

(2S)-4-amino-4-oxo-2-[(quinolin-2-ylcarbonyl)amino]butanoic acid

EP-A C14H13N3O4 287.27 O

HO

HN

O

N O

NH2

(3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-(1,1-

dimethylethyl)decahydroisoquinoline-3-carboxamide

(EP-C) USPRCA

670.84

N

HN

O

NH

O

NH2

O

OH

N

OHN CH3

CH3

CH3

H

H

Sertraline hydrochloride

(+/-)-Cis-4-phenyl-1,2,3,4-tetrahydro-N- methyl-1-

napthalenamine hydrochloride

EP-B 273.8 HN

CH3

. HCl

(D)- Mandelic acid.

EP-E 152.15 H

OH O

OH

(+/-)-Cis-4(4-chlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-

napthalenamine hydrochloride

EP-C 308.24 HN

CH3

Cl

. HCl

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

EP-F 291.17

Cl

O

H

Cl

(+)-cis-4-phenyl-1,2,3,4-tetrahydro-

N-methyl-1-naphthalenamine HCl.

EP-B C17H20ClN

Mol. Wt.: 273.80 NH

H

Cl

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

C16H13Cl2NO Mol. Wt.: 306.19

Cl

Cl

NHO

(1S,4R)-Trans-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-

N-methyl-1-naphthalenamine hydrrochloride.

EP-A 342.69

Cl

HN

Cl

CH3

. HCl

(1R,4R)-Cis-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-

naphthalenamine hydrochloride.

EP-G 342.69

Cl

HN

Cl

CH3

. HCl

Sildenafil citrate

5-{2-Ethoxy-5-[(4-{[4-ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-

1H-pyrazolo[4,3-d]pyrimidin-5-yl)phenyl]sulfonyl}piperazino)

sulfonyl]phenyl}-1-methyl-3-propyl-6,7-dihydro-1H-Pyrazol[4,3-

d]Pyrimidin-7-one.

C40H48N8O8S2 834.96

SNO O

N

HNN

N

O CH3

CH3N

SO

CH3O

O

OH3C

N

NH

H3C

CH3 O

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

4-{[4-Ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-1H-

pyrazolo[4,3-d]pyrimidin-5-yl)phenyl]sulfonyl}-1-

methylhexahydro pyrazin-1-ium-1-olate

C22H30N6O5S Mol. Wt.: 490.58 N+

N

O-

S OO

N

HNN

N

O

O

4-Ethoxy benzoic acid

C9H10O3 166.17

O

OH

O


C9H10O3 166.18

OHO

O CH3


C9H10O3 166.18

OHO

O CH3

4-Ethoxy -3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)benzenesulfonic

acid

C17H20N4O5S 392.43 S OO

OH

N

HNN

N

O

O

5-(2-Ethoxy phenyl)-1-methyl-3n-propyl-1,6-dihydro-7H-

pyrazolo[4,3-d]pyrimidine-7-one

C17H20N4O2 312.37

N

HNN

N

O CH3

CH3O CH3

1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-

d]pyrimidine-5-yl)-4-ethoxy phenyl]sulfonyl]-piperazine

C22H30N6O4S 474.58

O

SNO O

H3C

N

HNN

N

O CH3

CH3N

H3C

1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d]pyrimidine-5-yl)-4-ethoxy phenyl]sulfonyl]-piperazine.

C21H28N6O4S 460.55

SNO O

N

HNN

N

O CH3

CH3NH

O CH3

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

C8H12N4O3 212.21

NN

O

NH2

N+O-O

5-{2-Ethoxy-5-[(4-

methypiperzino)sulfonyl] phenyl}-3-ethyl-1-methyl-6,7-

dihydro -1H-pyrazolo[4,3-d]pyrimidin-7-one

(1S)-3,4-di-dihydro-1-phenyl-2-(1H)-isoquinoline carboxylic

acid(3R)-1-azabicyclo[2.2.2]oct-3-yl ester N-oxide.

N-Oxide EP-B

378.46

N O

O

N

H

O

Recimate (mixture of RS,SS,RR)

C23H26N2O2

362.46

N O

O

N

Stavudine

1-(2-Deoxy-beta-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-

dione

C10H14N2O5 242.23

HN

N

OO

HO

O

HO

5-Methylpyramidine-2,4(1H,3H)-dione

C7H9N2O3 169.16 C

O

HN

H2N

OO

3’,5’-Anhydro thymidine

3’,5’-Di-(O-mesyl)-thymidine

C12H18N2O9S2 398.41

O

O

ON

O

HN

O

SO

O

S

O

O 5’Benzoyl-2’,3’-didehydro-3’-

deoxythymidine

Sumatriptan

[3-[2-(Dimethylamino)ethyl]-2-[[3-[2-(dimethylamino)ethyl]-1H-indol-

5-yl] methyl]-1H-indol-5-yl]-N-methylmethanesulphonamide

succinate

Impurity-A/ Dimer

impurity

C27H37N5O2S Mol. Wt.: 495.68

NH

N

NH

N

SO

OHN

N-Methyl[3-[2-(methylamino)ethyl]-1H-indol-5-yl]

methane sulphon amide

Impurity-B/ Des methyl

impurity

C13H19N3O2S Mol. Wt.: 281.37

NH

NH

SO

OHN

[3-[2-(Dimethylamino)ethyl]-1-(hydroxymethyl)-1H-indol-5-yl]- N-

methylmethanesulphonamide succinate

Impurity-C/Hydroxy

methyl impurity

C15H23N3O3S Mol. Wt.: 325.43

N

N

SO

OHN

HO

N,N-Dimethyl-2-[5-[(methylsulphamoyl)methyl]-1H-indol-3-yl] ethanamine N-oxide

Impurity-D/N-Oxide

impurity

C14H21N3O3S Mol. Wt.: 311.40

NH

N

SO

OHN

O

[3-(2-Aminoethyl)-1H-indol-5-yl]-N-methylmethanesulphonamide

Impurity-E/Desdimethyl

impurity

C12H17N3O2S Mol. Wt.: 267.35

NH

NH2

SO

OHN

N-Methyl(2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indol-6-yl) methane

sulphonamide

Impurity-F/ Pyrido

indole impurity

C13H17N3O2S Mol. Wt.: 279.36

NH

SO

OHN

NH

N-Methyl(2-methyl-2,3,4,9-tetrahydro-1Hpyrido[3,4-b]indol-6-

yl) methanesulphonamide

Impurity-G/ Pyrido

indole methyl impurity

C14H19N3O2S Mol. Wt.: 293.38

NH

SO

OHN

N

[3-[2-(Dimethylamino)ethyl]-1-[[3-[2-(dimethylamino)ethyl]-1H-indol-

5-yl]methyl]-1H-indol-5-yl]-N-methylmethanesulphonamide

Impurity-H

C27H37N5O2S Mol. Wt.: 495.68

NH

N

N

SO

OHN

N

Tadalafil

1-Benzo[1,3]dioxol-5-yl-2,3,4,9-

tetrahydro-1H-b-carboline-3-

carboxylic acid

C19H16N2O4

Mol. Wt.: 336.34

NH

NH

OOH

O

O



carboxylic acid

C19H16N2O4

Mol. Wt.: 336.34

NH

NH

OOH

O

O

Tadalafil Piperonal

6-Benzo[1,3]dioxol-5-yl-2-methyl-

2,3,6,7,12,12a-hexahydro-

pyrazino[1',2':1,6]pyrido[3,4-

b]indole-1,4-dione

C22H19N3O4

Mol. Wt.: 389.40

NH

N

O

O

NO

O

6-Benzo[1,3]dioxol-5-yl-2-methyl-

2,3,6,7,12,12a-hexahydro-

pyrazino[1',2':1,6]pyrido[3,4-

b]indole-1,4-dione

C22H19N3O4

Mol. Wt.: 389.40

NH

N

O

O

NO

O

H

2-Acetylamino-3-(1H-indol-3-yl)-

propionic acid

C13H14N2O3

Mol. Wt.: 246.26

NH

OHO

HN

O

2-Amino-3-(1H-indol-3-yl)-

propionic acid

C11H12N2O2

Mol. Wt.: 204.23

NH

NH2

OOH



carboxylic acid methyl ester

Mehyl ester

C20H19ClN2O4

Mol. Wt.: 386.83

NH

NH.HCl

OO

OO

2-Amino-3-(1H-indol-3-yl)-

propionic acid methyl ester

D-Triptophan

methyl ester

C12H14N2O2

Mol. Wt.: 218.25

NH

NH2

OO

(IR,3R)-Methyl 1,2,3,4-tetrahydro-2-chloroacetyl-(3,4-

mehylenedioxyphenyl)-9H-Pyrido-[3,4-6]indole-3-carboxylate.

C22H19ClN2O5

Mol. Wt.: 426.85

NH

N

O

OCH3

Cl

O

O

O

(6S-12aS)-2,3,6,7,12,12l-

hexahydro-2-methyl-6-(3,4-methy

enedioxyphenyl)pyrazino[2,1:6]pyri

do[3,4-6]indole-1,4-dione

SS

DIASTERIOMER

C22H19N3O4

Mol. Wt.: 389.40

NH

N

N

O

O

O

O

CH3

(6R-12aS)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-

methylenedioxyphenyl)pyrazino[2,1:6]pyrido[3,4-6]indole-1,4-dione

(6S-12aS)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-

methylenedioxyphenyl)pyrazino[2,1:6]pyrido[3,4-6]indole-1,4-dione.

RS

DIASTERIOMER

C22H19N3O4 Mol. Wt.: 389.40

NH

N

N

O

O

O

O

CH3

(6S-12aR) -2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-

methylenedioxyphenyl)pyrazino[2,1:6] pyrido [3,4-6] indole -1,4-

dione.

SR

DIASTERIOMER

C22H19N3O4

Mol. Wt.: 389.40

NH

N

N

O

O

O

O

CH3

Tamsulosin hydrochloride

Methanesulfonic acid 2-(2-ethoxy-phenoxy)-ethyl ester

2-EPEM

C11H16O5S Mol. Wt.: 260.3131

O

O

OSO

O

5-(2-Amino-propyl)-2-methoxy-benzenesulfonamide

Imp-B/TAM-III HCl

C10H16N2O3S Mol. Wt.: 244.31

H3CO

SO2NH2

NH2

H

Tamsulosin Hydrochloride Imp-A/Trialkyl

impurity

C30H40N2O7S Mol. Wt.: 572.71

H3CO

SO2NH2

N O

O

O

O

2-Methoxy-5-[2-(2-phenoxy-ethylamino)-propyl]-benzenesulfonamide

Imp-C/Desethoxy impurity

C18H24N2O4S Mol. Wt.: 364.46

H3CO

SO2NH2

HN O

3-{2-[2-(2-Ethoxy-phenoxy)-ethylamino]-propyl}-benzenesulfonamide

Imp-D/Methoxy impurity

C19H26N2O4S Mol. Wt.: 378.49

SO2NH2

HN O

O

5-Formyl-2-methoxy-benzenesulfonamide

Imp-E/Sulphonyl impurity

C8H9NO4S Mol. Wt.: 215.23

SO2NH2

H

O

H3CO

5-{2-[2-(2-Ethoxy-phenoxy)-ethylamino]-propyl}-2-methoxy-

benzenesulfonamide Imp-G/S-isomer

C20H28N2O5S Mol. Wt.: 408.51

SO2NH2

HN O

O

H

H3CO

[2-(2-Ethoxy-phenoxy)-ethyl]-[2-(4-methoxy-phenyl)-1-methyl-ethyl]-

amine

Imp-H/Desulphonami

de impurity

C20H27NO3 Mol. Wt.: 329.43 H

N O

O

H

H3CO

2-(2-Ethoxy-phenoxy)-ethylamine Imp-F/Amine

impurity

C10H15NO2 Mol. Wt.: 181.23

O

O

NH2 Telmisartan

4-(1,7'-Dimethyl-2'-propyl-1H-

[2,5']bibenzoimidazolyl-3'-

ylmethyl)-biphenyl-3-carboxylic

acid methyl ester

C34H32N4O2

528.64

N

N N

N

H3CO

O

1,7'-Dimethyl-2'-propyl-1H,3'H-

[2,5']bibenzoimidazolyl

Desmethyl C19H20N4

Mol. Wt.: 304.39

N

N NH

N

7-Methyl-2-propyl-3H-

benzoimidazole-5-carboxylic acid

C12H14N2O2

Mol. Wt.: 218.25

HO

O NH

N

IMPURITY

C46H38N4O4

Mol. Wt.: 710.82

N

N N

N

OH

O

HO

O

1,7'-Dimethyl-2'-propyl-1H,3'H-

[2,5']bibenzoimidazolyl

C19H20N4

Mol. Wt.: 304.39

N

N NH

N

4'-(5-Chloro-1,7'-dimethyl-2'-

propyl-1H-[2,5']bibenzoimidazolyl-

3'-ylmethyl)-biphenyl-2-carboxylic

acid

Chloro Impurity C33H29ClN4O2

Mol. Wt.: 549.06

N

N N

N

ClCOOH

4'-(1,7'-Dimethyl-2'-propyl-1H-



acid

Impurity-B C33H30N4O2

Mol. Wt.: 514.62

N

N N

N

HOOC



ylmethyl)-biphenyl-2-carbonitrile

Nitrile impurity

C33H29N5

Mol. Wt.: 495.62

N

N N

N

CN




acid amide

Amide impurity

C33H31N5O

Mol. Wt.: 513.63

N

N N

N

O

NH2

3-(2'-Carboxy-biphenyl-4-ylmethyl)-

7-methyl-2-propyl-3H-

benzoimidazole-5-carboxylic acid

Diacid impurity C26H24N2O4

Mol. Wt.: 428.48

HOOC N

N

O

OH

4'-Methyl-biphenyl-2-carboxylic

acid

C14H12O2

Mol. Wt.: 212.24

H3C

HOOC

4'-Methyl-biphenyl-2-carbonitrile

C14H11N

Mol. Wt.: 193.24

H3C

NC

4'-Methyl-biphenyl-2-carboxylic

acid methyl ester

C15H14O2

Mol. Wt.: 226.27

H3C

H3COOC

Methyl 4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-

benzimidazole-1-yl]methyl]biphenyl-2-carboxylate.

C34H32N4O2 528.64

OO

N

NN

N

4-methyl-6-(1-Methyl-1H-benzimidazol-2-yl)-2-propyl-1H-

benzimidazole

EP-A C19H20N4

Mol. Wt.: 304.39 N

N

CH3

N

NH

CH3

CH3

4'-[[7-methyl-5-(1-methyl-1H-

Benzimidazol-2yl)-2-propyl-1H-

benzimidazol-1-yl]methyl]biphenyl-

2-carboxylic acid

C33H30N4O2

Mol. Wt.: 514.62 N

N

CH3

N

N

CH3

CH3 OHO

1-[(2’-Carboxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-

benzimidazol-6-carboxylic acid

EP-E C26H24N2O4 428.48 N

N

O

HO OOH

4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-

benzimidazol-1-yl]methyl]biphenyl-2-carboxamide

EP-F C33H31N5O 513.63

OH2N

N

NN

N

4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-

benzimidazol-1-yl]methyl]biphenyl-2- carbonitrile

EP-G C33H29N5 495.62

NN

NN

N

Methyl 4’-(bromo methyl)biphenyl-

2-carboxyalte.

4’**4-Methyl-6-(1-(methyl biphenyl-2-carboxylicacid)-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carboxlicacid

Terbinafinehcl

N-methyl-C-(naphthalene-1-yl)methanamine

C12H13N Mol. Wt.: 171.24 NH

H3C

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

en-4-yn-1-amine.

C21H26ClN

Mol. Wt.: 327.89 N CH3

CH3CH3H3C

.HCl

1-Bromo-6,6-dimethyl hept-2-ene-4-yne

C9H13Br

Mol. Wt.: 201.10 Br CH3

CH3CH3

Tizanidine

(5-Chloro-benzo[1,2,5]thiadiazol-4-yl)-thiourea

Impurity-B

C7H5ClN4S2 Mol. Wt.: 244.72

NH

Cl NS

N

NH2

S

Tizanidine Impurity-C/ Dimer imp

C16H14Cl2N10S2 Mol. Wt.: 481.39

NH

Cl NS

N

NH

HN NH

NH

NH

NS

N

Cl

1-(5-Chloro-benzo[1,2,5]thiadiazol-4-yl)-2-methyl-isothiourea

Impurity-D

C8H7ClN4S2 Mol. Wt.: 258.75

NH

Cl NS

N

NH

S

5-Chloro-benzo[1,2,5]thiadiazol-4-ylamine

Impurity-E

C6H4ClN3S Mol. Wt.: 185.63

NH2

Cl NS

N

Tizanidine Imp-F

C16H11Cl2N9S2 Mol. Wt.: 464.35

ClNH

HN N

Cl

HN

N

NS

N

N

NS

Topiramate

2,3,4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranosyl

sulphonylchloride

C12H20ClO7S 343.80

HO

OO

O

O

S

O

OCl

2,3,4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose

C13H22O5

258.31

O

O

O O

CH3

CH3

H3C

H3C

HO

n h .h 2s o 4 h o - crimson international · 2016-11-05 · amlodipine ep impurity d ; amlodipine...

Documents