List of Impurities & Working Standards

SR. NO.

PRODUCT

STANDARDS

CHEMICAL NAME

PHARMACOPIA / INHOUSE

1

ALLOPURINOL

ALLOPURINOL

1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one

EP & USP

IMPURITY-A

5-amino-1H-pyrazole-4-carboxamide

EP & USP

IMPURITY-B

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

EP & USP

IMPURITY-C

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

EP & USP

IMPURITY-D

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

USP

IMPURITY-E

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

USP

2

BRINZOLAMIDE

BRINZOLAMIDE

(R)-4-(Ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno
[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-dioxide    

USP

IMPURITY-C

(2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazole-4-yloxy)propan-2-ol

INHOUSE

BZM4 RACEMIC

(4S)-6-chloro-3,4-dihydro-2H-thieno[3,2-e][1,2] thiazin-4-ol 1,1-dioxide Racemic standard

INHOUSE

BZM6 RACEMIC

4(R)(S)-4-hydroxy-2-(3-methoxypropyl)-3,4-dihydro-2H-theino[3,2-e][1,2][thiazine-6-sulfonamide 1,1-dioxide Racemic standard

INHOUSE

BZM RACEMIC

(S)(R)-(-)-4-Ethylamino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2-e]-thiazine-6-sulphonamide-1,1-dioxide

INHOUSE

3

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

(4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b] thiopyran-2- sulfonamide 7,7-dioxide, monohydrochloride

EP&USP

IMPURITY-A

(4R,6R)-4-(ethyl amino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide

EP & INHOUSE

IMPURITY-B

(4R,6S)-4-(ethyl amino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide

EP & INHOUSE

4

BRIMONIDINE TARTRATE

BRIMONDINE TARTRATE

5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalin-6-amine tartrate

NON-PHARMACOPIAL

IMPURITY-A

5-bromoquinoxalin-6-amine

 INHOUSE

IMPURITY-B

N-[(2E)-1-acetylimidazolidin-2-ylidene]-5-bromoquinoxalin-6-amine

INHOUSE

IMPURITY-C

N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine

INHOUSE

IMPURITY-H

5-Chloro-N-(imidazolidin-2-ylidene) quinoxalin-6-amine tartrate

INHOUSE

IMPURITY-E

2-(5-bromoquinoxalin-6-yl)guanidine

EP

IMPURITY-D

2-[(5-bromoquinoxalin-6-yl)amino]imidazolidin-2-ol

INHOUSE

5

RASAGILINE MESYLATE

RASAGILINE MESYLATE RACEMIC

(1R,S)-N-Prop-2-yn-1-ylindan-1-amine methanesulfonic acid salt

INHOUSE

RSG CHLORO IMPURITY

RSG Chloro impurity(TRANS)

INHOUSE

6

QUETIAPINE FUMARATE

QUETIAPINE FUMARATE

2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)
ethoxy] ethanol hemifumarate

NON-PHARMACOPIA

IMPURITY-C

Dibenzo[b,f][1,4]thiazepine-11(10H)one

INHOUSE

IMPURITY-B (EP)

11-(piperazin-1-yl) dibenzo [b, f][1, 4] thiazepine dihydrochloride

EP

DES ETHOXY IMPURITY

2-[2-(4-Dibenzo[b,f][1,4]thiazepine 11-yl-piperazinyl)] ethanol hydrochloride

INHOUSE

7

FEBUXOSTAT

FEBUXOSTAT

2-(3-cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid

NON-PHARMACOPIA

IMPURITY-A

Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate

INHOUSE

IMPURITY-B

Ethyl 2-(3-carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate

INHOUSE

8

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

[Bicyclohexyl]-1-carboxylic acid, 2-(diethylamino)ethyl ester, hydrochloride

EP &USP

IMPURITY A

Bicyclohexyl-1-carboxylic acid

EP

IMPURITY B

2-(diethylamino)ethyl-1,1’-bi(cyclohexane)-1’-ene-12-carboxylate

INHOUSE

9

BESIFLOXACIN HYDROCHLORIDE

IMPURITY E

7-[(3R)-azepan-3-ylamino]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.

INHOUSE

IMPURITY F

7-[(3R)-azepan-3-ylamino]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.

INHOUSE

IMPURITY D

BFX Dimer Impurity

INHOUSE

IMPURITY G

(R)-3-Amino Hexahydro-1H-Azepan

INHOUSE

BESIFLOXACIN HYDROCHLORIDE RACEMIC

7-[(3RS)-aminoazepan-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxoquinoline-3-carboxylic acid hydrochloride.

INHOUSE

10

 

LACOSAMIDE

LACOSAMIDE (S) ISOMER

2S-(acetylamino)-3-methoxy-N-(phenylmethyl)-propanamide

INHOUSE/EP(A)

LACOSAMIDE IMPURITY A

(2R)-2-amino-N-benzyl-3-methoxypropanamide

INHOUSE

BBC1 R ISOMER

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

INHOUSE

BBC S ISOMER

Tert-butyl [(1S)-2-(benzylamino)-1-(hydroxymethyl-2-oxoethyl]carbamate

INHOUSE

LACOSAMIDE IMPURITY B/
(O-ACETYL IMPURITY)

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

EP

LACOSAMIDE IMPURITY F

(2R)-2-(acetylamino)-N-benzyl-3-hydroxypropanamide

EP

11

APIXABAN

METHYL ESTER IMP (IMPURITY B)

Methyl-1-(4-methoxy phenyl)-7-oxo-6-(4-(2-oxopiperidine-1-yl)phenyl)-4,5,6,7,-tetrahydro-1H-pyrazolo(3,4,-C)pyridine-3-carboxylate

INHOUSE

APIXABAN

APIXABAN

INHOUSE

APX 3 (IMPURITY A)

1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidine-1-yl) phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo [3,4-c]pyridine-3-carboxylic acid

INHOUSE

12

CANAGLIFLOZIN

CANAGLIFLOZIN

CANAGLIFLOZIN

INHOUSE

IMPURITY A
CGF DIASTEREOMER)

(2R, 3R, 4R, 5S, 6R)-2-(3-((5-(4-fluorophenyl) thiophene-2-yl) methyl)-4-methylphenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3, 4, 5-triol (CGF Diastereomer)

INHOUSE

IMPURITY B

(2S,3R, 4R, 5S, 6S)-(6-(3-((5-(4-fluorophenyl) thiophene-2-yl) methyl)-4-methylphenyl)- 3, 4, 5-trihydroxy tetrahydro-2H-pyran-2-yl) methyl acetate

INHOUSE

IMPURITY C

(2S,3R, 4R, 5S, 6S)-3, 4, 5-tris (ydroxyl)-2-((benzyloxy) methyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl-4-methylphenyl) tetrahydro-2H-pyran

INHOUSE

CGF4 DIASTEREOMER

(2R,3R, 4R, 5S, 6S)-3, 4, 5-tris (benzyloxy)-2-((benzyloxy) methyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)-methyl)-4-methyl-phenyl) tetrahydro-2H-pyran (CGF4 Diastereomer)

INHOUSE

13

ALOGLIPTIN

ALOGLIPTIN

ALOGLIPTIN WORKING STANDARD

INHOUSE

IMPURITY A

(R)-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile

INHOUSE

IMPURITY B

2-(bromomethyl)benzonitrile

INHOUSE

IMPURITY C

(R)-2-((1-(3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidine-3-ylamino)methyl)benzonitrile

INHOUSE

IMPURITY D

(R)-2-((6-(1-(3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-ylamino)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile

INHOUSE

IMPURITY E

(R)-N-(1-(3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl) piperidin-3-yl) benzamide

INHOUSE

AGP (S-ISOMER)

(S)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl) benzonitrile benzoate.

INHOUSE

AGP RACEMIC

2-(6-(3-aminopiperidine-1-yl)-3-methyl-2-4-dioxo-3,4-dihydropyridin-1-(2H)-yl)methyl benzonitrile benzoate

INHOUSE

14

MIRABEGRON

 

 

 

MIRABEGRON

MIRABEGRON WORKING STANDARD

INHOUSE

MBR DEHYDROXY IMPURITY(IMP A)

2-(2-aminothiazol-4-yl)-N-(4-(2-(phenethylamino)ethyl)phenyl)acetamide

INHOUSE

MBR IMP D

(R)N-(4-(2aminothiazol-4-yl)acetamido)phenethyl-(2-hydroxy-2-phenylethyl acetamide

INHOUSE

MBR RACEMIC

Mirabegron

INHOUSE

 

Achievements

 

  • Characterization and isolation of Impurity of Dicyclomine
  • Characterization and isolation -Impurities of Omeprazole
  • Characterization and isolation- Impurities of Formulated products
  • Analytical Methods for Chiral Intermediates of Dorzolamide HCl
  • Polymorphism in Desloratidine
  • More than 100 in-house impurity standards.
  • Validation of Particle size analysis method for customer
  • Validation of Quantitative XRD methods for Customer