IRBESARTAN

Name

Irbesartan

Molecular Formula

C25H28N6O

Molecular Weight

428.53

QualityStandard

EP/USP

Package Size

25kg/drum

Brief Introduction

Irbesartan is an angiotensin II receptor antagonist used mainly for
the treatment of hypertension. It was developed by Sanofi Research
(now part of Sanofi-Aventis). It is jointly marketed by Sanofi-Aventis
and Bristol-Myers Squibb under the trade names Aprovel, Karvea, and Avapro.

ITEMS

SPECIFICATION

RESULTS

APPEARANCE

WHITE TO OFF-WHITE,CRYSTALLINE POWDER

WHITE CRYSTALLINE POWDER

IDENTIFICATION

INFRARED ABSORPTION:THE IR SPECTRUM IS CONSISTENT WITH THAT OBTAINED WITH THE REFERENCE

CONFORMS

THE RETENTION TIME OF THE MAJOR PEAK IN THE CHROMATOGRAM OF THE ASSAY PREPARATION CORRESPONDS TO THAT IN THE CHROMATOGRAM OF THE STANDARD PREPARATION,AS OBTAINED IN THE ASSAY

CONFORMS

WATER

NMT 0.5%

0.24%

LIMIT OR AZIDE

NMT 10PPM

NOT DETECTED

HEAVY METALS

NMT 0.002%

CONFORMS

RELATED COMPOUNDS

COMPOUND A NMT 0.2%

0.01%

ANY OTHER IMPURITY NMT 0.1%

0.04%

TOTAL IMPURITIES NMT 0.5%

0.09%

RESIDUAL SOLVENTS(GC)

ETHANOL NMT 5000PPM

2307PPM

TOLUENE NMT 890PPM

238PPM

DICHLOROMETHANE NMT 600PPM

NOT DETECTED

N,N-DIMETHYLFORMAMIDE NMT 880PPM

NOT DETECTED

T-BUTYL METHYL ETHER NMT 5000PPM

NOT DETECTED

ASSAY(ON THE ANHYDROUS BASIS)

98.0%~102.0%

99.1%

CONCLUSION:THE ANALYSTS RESULTS SHOW THAT THIS BATCH OF IRBESARTAN CONFORMS TO USP