API IMPURITIES

Bazedoxifene Acetate

API Name :

Bazedoxifene acetate

Impurity Code:

Monohydroxy impurity

Chemical Name:

4-{1-[4-(2-Azepan-1-yl-ethoxy)-benzyl-5-benzyloxy-3-methyl-1 H-indole-2-yl}-phenol

CAS No:

328933-58-0

Molecular formula:

C37H40N2O3

Molecular weight:

560.73

API Name :

Bazedoxifene acetate

Impurity Code:

Dihydroxy impurity

Chemical Name:

2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol

CAS No:

91444-54-1

Molecular formula:

C15H13NO2

Molecular weight:

239.27

API Name :

Bazedoxifene acetate

Impurity Code:

Trihydroxy impurity

Chemical Name:

1-(4-Hydroxy-benzyl)-2-(4-hydroxy-phenyl)-3-methyl-1H-indole-5-ol

CAS No:

104599-10-2

Molecular formula:

C22H19NO3

Molecular weight:

345.39

API Name :

Bazedoxifene acetate

Impurity Code:

Aza-indole impurity

Chemical Name:

1-(4-(2-(Azepan-1-yl)ethoxy)benzyl)-5-(benzyloxy)-2-(4-benzyloxy)phenyl)-3-methyl-1H-indole

CAS No:

198480-21-6

Molecular formula:

C44H46N2O3

Molecular weight:

650.85

API Name :

Bazedoxifene acetate

Impurity Code:

N-Oxide impurity

Chemical Name:

1-(4-(2-(Azepan-1-yl)ethoxy)benzyl)-5-(benzyloxy)-2-(4-benzyloxy)phenyl)-3-methyl-1H-indole

CAS No:

1174289-22-5

Molecular formula:

C30H34N2O4

Molecular weight:

486.60

API Name :

Bazedoxifene acetate

Impurity Code:

Ketoamine impurity

Chemical Name:

1-(4-(benzyloxy)phenyl)-2-(4-benzyloxy)phenylamino-propan-1-one

CAS No:

1048697-94-4

Molecular formula:

C29H27NO3

Molecular weight:

437.53

Mirabegron

API Name :

Mirabegron

Impurity Code:

Amine impurity

Chemical Name:

(R)-2-(4-Aminophenethylamino)-1-phenylethanol hydrochloride

CAS No:

391901-45-4

Molecular formula:

C16H21ClN2O

Molecular weight:

292.80

API Name :

Mirabegron

Impurity Code:

Amide impurity

Chemical Name:

N-(2-{4-[2-(2-Amino-thiozol-4-yl)acetyl amino]-phenyl}-ethyl-2-hydroxy-2-phenyl-acetamide

CAS No:

Molecular formula:

C21H22N4O3S

Molecular weight:

410.49

API Name :

Mirabegron

Impurity Code:

Deshydroxy impurity

Chemical Name:

2-(2-Amino-thiozol-4-yl)-N [4-(2-phenethyl amino-ethyl)-phenyl]-acetamide

CAS No:

1581284-82-3

Molecular formula:

C21H24N4OS

Molecular weight:

380.51

API Name :

Mirabegron

Impurity Code:

S-Isomer

Chemical Name:

(S) -2-(2-amino thiozol-4-yl)-4-[2-[(2-hydroxy-2-phenyl ethyl) amino] ethyl] acetamide

CAS No:

1796931-48-0

Molecular formula:

C21H24N4O2S

Molecular weight:

396.51

API Name :

Mirabegron

Impurity Code:

Bis impurity

Chemical Name:

2-(2-Amino-thiozol-4-yl)-N-(4-{2-[[2-(2-amino-thiazol-4-yl)-acetyl]-(2-hydroxy-2-phenyl-ethyl)-amino} -ethyl}-phenyl)-acetamide

CAS No:

1684452-83-2

Molecular formula:

C26H28N6O3S2

Molecular weight:

536.67

API Name :

Mirabegron

Impurity Code:

S-isomer of KSM

Chemical Name:

((S)-2-((4-nitrophenethyl) amino)-1-phenylethanol hydrochloride

CAS No:

Molecular formula:

C16H19ClN2O3

Molecular weight:

322.79

API Name :

Mirabegron

Impurity Code:

Deshydroxy imp of MIR1

Chemical Name:

4-(2-(phenethylamino)ethyl)aniline hydrochloride

CAS No:

1581285-26-8

Molecular formula:

C16H21ClN2

Molecular weight:

276.80

Dronedarone Hydrochloride

API Name :

Dronedarone Hydrochloride

Impurity Code:

Des-butyl impurity

Chemical Name:

N-{2-Butyl-3-[4-(3-butylamino-propoxy)-benzoyl]-benzofuran-5-yl}methanesulfonamide

CAS No:

Molecular formula:

C27H36N2O5S

Molecular weight:

500.65

API Name :

Dronedarone Hydrochloride

Impurity Code:

Des-mesyl impurity

Chemical Name:

(5-Amino-2-butyl-benzofuran-3-yl)-[4-(3-dibutylamino-propoxy)-phenyl]-methanone

CAS No:

Molecular formula:

C30H42N2O3

Molecular weight:

478.67

API Name :

Dronedarone Hydrochloride

Impurity Code:

Di mesyl impurity

Chemical Name:

N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)-N-(methylsulfonyl) methane sulfonamide

CAS No:

Molecular formula:

C32H46N2O7S2

Molecular weight:

634.85

API Name :

Dronedarone Hydrochloride

Impurity Code:

N-oxide impurity

Chemical Name:

N-[2-n-Butyl-3-[4-[3-(di-n-butylamino)propoxy]benzoyl] benzofuran-5-yl]methanesulfonamid -N-oxide

CAS No:

1638586-56-7

Molecular formula:

C31H44N2O6S

Molecular weight:

572.76adf

Cinacalcet Hydrochloride

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Amine impurity

Chemical Name:

(R)-(+)-1-(2-Naphthyl)ethylamine Hydrochloride

CAS No:

3906-16-9

Molecular formula:

C12H14ClN

Molecular weight:

207.70

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Benzyl amine impurity

Chemical Name:

(R)-a-methyl-N-[3-[3-(trifluoromethyl)phenyl]methyl]-1-naphtalenemethane amine

CAS No:

Molecular formula:

C20H18F3N

Molecular weight:

329.36

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Bis impurity

Chemical Name:

(1-Napthalen-1-yl-ethyl)-bis-[3-(3-triflurometyhl-phenyl]-propyl)-amine

CAS No:

1271930-15-4

Molecular formula:

C32H31F6N

Molecular weight:

543.59

API Name :

Cinacalcet Hydrochloride

Impurity Code:

N-oxide impurity

Chemical Name:

(R )-N-(1-(Naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl) phenyl)propan-1-amine N-oxide

CAS No:

1229224-94-5

Molecular formula:

C22H21F3NO-

Molecular weight:

372.40

API Name :

Cinacalcet Hydrochloride

Impurity Code:

S-Isomer impurity

Chemical Name:

(S)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-aminehydrochloride

CAS No:

226256-56-0

Molecular formula:

C22H22F3N

Molecular weight:

357.41

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Carbamate impurity

Chemical Name:

3-(3-(trifluoromethyl)phenyl)propyl 1-(naphthalen-5-yl)ethylcarbamate

CAS No:

Molecular formula:

C23H22F3NO2

Molecular weight:

401.42

API Name :

Cinacalcet Hydrochloride

Impurity Code:

mixture

Chemical Name:

(SR)-N-1-(naphthalen-1-yl) ethyl)-2-(3-(trifluoromethyl)phenyl) propan-1-amine

CAS No:

Molecular formula:

C22H22F3N

Molecular weight:

357.41

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Diasteromer-2

Chemical Name:

(R)-N-((R)-1-(naphthalen-1-yl)ethyl)-2-(3-(trifluoromethyl)phenyl)propan-1-amine

CAS No:

Molecular formula:

C22H22F3N

Molecular weight:

357.41

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Cinacalcet bete-arylated impurity

Chemical Name:

2-(3-(trifluoromethyl)phenyl) propanal

CAS No:

1034094-54-6

Molecular formula:

C10H9F3O

Molecular weight:

202.17

API Name :

Cinacalcet Hydrochloride

Impurity Code:

Regioisomer

Chemical Name:

(R)-N-(1-(naphthalen-2-yl) ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine

CAS No:

Molecular formula:

C22H22F3N

Molecular weight:

357.41

Lacosamide

API Name :

Lacosamide

Impurity Code:

Carbamate impurity

Chemical Name:

Benzyl-carbamic acid isobutyl ester

CAS No:

Molecular formula:

C12H17NO2

Molecular weight:

207.27

API Name :

Lacosamide

Impurity Code:

Hydroxy impurity

Chemical Name:

(R)-2-Acetamido-N-benzyl- -3-hydroxy propanamide

CAS No:

175481-38-6

Molecular formula:

C12H16N2O3

Molecular weight:

236.27

API Name :

Lacosamide

Impurity Code:

Hydroxy impurity

Chemical Name:

(R)-2-Acetamido-N-benzyl- -3-hydroxy propanamide

CAS No:

175481-38-6

Molecular formula:

C12H16N2O3

Molecular weight:

236.27

API Name :

Lacosamide

Impurity Code:

O-Isobutyl impurity

Chemical Name:

(R) -2-(benzylcarbamoyl)-2-acetamidoethyl isobutyl carbonate

CAS No:

Molecular formula:

C17H24N2O5

Molecular weight:

336.38

API Name :

Lacosamide

Impurity Code:

O-Isobutyl impurity

Chemical Name:

(R) -2-(benzylcarbamoyl)-2-acetamidoethyl isobutyl carbonate

CAS No:

Molecular formula:

C17H24N2O5

Molecular weight:

336.38

API Name :

Lacosamide

Impurity Code:

O-Acetyl impurity

Chemical Name:

(R)-2-Acetamido-3-benzylamino-3-oxopropyl acetate

CAS No:

1318777-54-6

Molecular formula:

C14H18N2O4

Molecular weight:

278.30

API Name :

Lacosamide

Impurity Code:

Acetamide impurity

Chemical Name:

N-Benzyl acetamide

CAS No:

Molecular formula:

C9H11NO

Molecular weight:

149.19

API Name :

Lacosamide

Impurity Code:

Benzyl amino impurity

Chemical Name:

(R)-2-Amino-N-benzyl-3- Methoxypropanamide

CAS No:

1322062-76-9

Molecular formula:

C11H16N2O2

Molecular weight:

208.26

API Name :

Lacosamide

Impurity Code:

Dimer Impurity

Chemical Name:

( R)-2-[(R)-2-acetamido-3-methoxy propanamido]-N-benzyl-3-methoxy propanamide

CAS No:

Molecular formula:

C17H25N3O5

Molecular weight:

351.40

API Name :

Lacosamide

Impurity Code:

LAC-1 isomer

Chemical Name:

(S)-2-acetamido-N-benzyl-3-hydroxypropanamide

CAS No:

171623-03-03

Molecular formula:

C12H16N2O3

Molecular weight:

236.27

API Name :

Lacosamide

Impurity Code:

LAC-2 NMBA

Chemical Name:

(R)-2-acetamodo-N-benzyl-3-methoxy-N-methylpropanamide

CAS No:

171623-03-03

Molecular formula:

C14H20N2O3

Molecular weight:

264.32

API Name :

Lacosamide

Impurity Code:

LAC-Enantiomer

Chemical Name:

(S)-2-acetamido-N-benzyl-3-methoxypropanamide

CAS No:

175481-37-5

Molecular formula:

C13H18N2O3

Molecular weight:

250.29

API Name :

Lacosamide

Impurity Code:

Propenamide acid impurity

Chemical Name:

N-Benzyl-2-acetamido-2-propene acid amide impurity

CAS No:

86921-49-5

Molecular formula:

C12H14N2O2

Molecular weight:

218.25

API Name :

Lacosamide

Impurity Code:

Desacetyl-Desmethyl impurity

Chemical Name:

2-Amino-N-benzyl-3-hydroxy-propionamide

CAS No:

175481-39-7

Molecular formula:

C10H14N2O2

Molecular weight:

194.23

API Name :

Lacosamide

Impurity Code:

Propionamide Impurity

Chemical Name:

N-Benzyl-3-methoxy-2-propionylamino-propionamide

CAS No:

1318777-56-8

Molecular formula:

C14H20N2O3

Molecular weight:

264.32

Dabigatran Etexilate Mesylate

API Name :

Dabigatran Etexilate Mesylate

Impurity Code:

Methyl ester impurity

Chemical Name:

Methyll 2-{[(4-N-hexyloxy carbonyl carbmimidaoyl phenyl)amino]methyl}-1-methyl-1H-benzimidazole-5-carboxylate

CAS No:

Molecular formula:

C33H39N7O5

Molecular weight:

613.71

API Name :

Dabigatran Etexilate Mesylate

Impurity Code:

DBG-3A Desamino pyridine

Chemical Name:

(E)-2-(((4-(N’-((hexyloxy )carbonyl) carbamimidoyl) phenyl) amino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carboxylic acid

CAS No:

Molecular formula:

C24H29N5O4

Molecular weight:

451.52

API Name :

Dabigatran Etexilate Mesylate

Impurity Code:

Ethyl ester impurity

Chemical Name:

Ethyl 2-{[(4-N-hexyloxy carbonyl carbmimidaoyl phenyl)amino]methyl}-1-methyl-1H-benzimidazole-5-carboxylate

CAS No:

Molecular formula:

C17H17N5O2

Molecular weight:

323.35

API Name :

Dabigatran Etexilate Mesylate

Impurity Code:

Amidine ester impurity

Chemical Name:

Ethyl 2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1H-benzimidazole-5-carboxylate hydrochloride

CAS No:

Molecular formula:

C19H22ClN5O2

Molecular weight:

387.86

Asenapine

API Name :

Dabigatran Asenapine

Impurity Code:

ASM-6 regioisomer-I

Chemical Name:

trans-(3aRS,12bRS)-11-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7] oxepino[4,5-c] pyrrol-1-one

CAS No:

129385-59-7

Molecular formula:

C17H14ClNO2

Molecular weight:

299.75

API Name :

Dabigatran Asenapine

Impurity Code:

ASM-6 regioisomer-II

Chemical Name:

trans-(3aRS,12bRS)-11-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz

[2,3:6,7]oxepino[4,5-c]pyrrol-1-one

CAS No:

129385-59-7

Molecular formula:

C17H14ClNO2

Molecular weight:

299.75

API Name :

Dabigatran Asenapine

Impurity Code:

ASM-5

Chemical Name:

cis-(3aRS,12bRS)-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrol-1-one

CAS No:

912356-09-3

Molecular formula:

C17H14ClNO2

Molecular weight:

299.75

Desloratadine

API Name :

Dabigatran Desloratadine

Impurity Code:

Carbonitrile impurity

Chemical Name:

3-[2-(3-chlorophenyl)ethyl] pyridine-2-carbonitrile

CAS No:

31255-57-9

Molecular formula:

C14H11ClN2

Molecular weight:

242.70

API Name :

Dabigatran Desloratadine

Impurity Code:

Bromo-DEL1

Chemical Name:

4-(8-Bromo-5,6-dihydro-benzo[5,6]cycloheptal[1,2b]pyridin-11-ylidene)-piperdine-1-carboxylic acid ethyl ester

CAS No:

Molecular formula:

C22H23BrN2O2

Molecular weight:

427.33

API Name :

Dabigatran Desloratadine

Impurity Code:

Bromo impurity DES-1

Chemical Name:

8-bromo-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

CAS No:

117796-50-6

Molecular formula:

C19H19BrN2

Molecular weight:

355.27

API Name :

Dabigatran Desloratadine

Impurity Code:

Uncyclized impurity, TRL related

Chemical Name:

(1-methyl-4-piperidinyl)-3-[2-(3-chlorophenyl) ethyl]-2-pyridinyl-methanone

CAS No:

130642-50-1

Molecular formula:

C20H23ClN2O

Molecular weight:

342.86

API Name :

Dabigatran Desloratadine

Impurity Code:

TRL-Bromo impurity

Chemical Name:

8-Bromo-11- (1-methyl-4- piperidinylidene)-6,11-dihydro-5H- Benzo [5,6] cyclohepta [1,2-b] pyridine

CAS No:

130642-57-8

Molecular formula:

C20H21BrN2

Molecular weight:

369.30

Valsartan

API Name :

Valsartan

Impurity Code:

Isoleucine impurity of CBM

Chemical Name:

N-((2′-cyanobiphenyl-4-yl)methyl)-L-isoleucine methyl ester

CAS No:

137863-88-8

Molecular formula:

C21H24N2O2

Molecular weight:

336.43

API Name :

Valsartan

Impurity Code:

Butyryl valsartan impurity

Chemical Name:

(S)-N-butyryl-N-{[2’-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl} valine

CAS No:

952652-79-8

Molecular formula:

C23H27N5O3

Molecular weight:

421.49

Atorvastatin

API Name :

Atorvastatin

Impurity Code:

Desflouro atorvastatin

Chemical Name:

Calcium (3R,5R)-3,5-dihydroxy-7-(2-isopropyl-4.5-diphenyl-3-(phenylcarbamoyl)-1H-pyrool-1-yl)heptanoate

CAS No:

433289-83-9

Molecular formula:

C21H24N2O2

Molecular weight:

1119.38

Irbesartan

API Name :

Irbesartan

Impurity Code:

Pentanoic acid amide

Chemical Name:

N-(1-cyanocyclopentyl)pentanamide

CAS No:

194984-24-2

Molecular formula:

C11H18N2O

Molecular weight:

194.27

Olmesartan

API Name :

Olmesartan

Impurity Code:

Olmesartan impurity

Chemical Name:

4-chloro-4-methyl-5-methylene-1,3-dioxolan-2-one

CAS No:

95579-71-8

Molecular formula:

C5H5ClO3

Molecular weight:

148.54

Ranolazine

API Name :

Ranolazine

Impurity Code:

Ranolazine impurity

Chemical Name:

1,3-bis-(2-methoxyphenoxy)propane-2-ol

CAS No:

16929-60-5

Molecular formula:

C17H20O5

Molecular weight:

304.34

API Name :

Ranolazine

Impurity Code:

Dichloro Impurity

Chemical Name:

2, 2-Dichloro-N-(2, 6-dimethylphenyl) acetamide

CAS No:

39084-88-3

Molecular formula:

C10H11Cl2NO

Molecular weight:

232.11

API Name :

Ranolazine

Impurity Code:

Ranolazine Related Compound D

Chemical Name:

1, 4-Bis-[(2, 6-dimethylphenyl)-aminocarbonylmethyl]piperazine

CAS No:

C24H32N4O2

Molecular formula:

C10H11Cl2NO

Molecular weight:

408.54