VALSARTAN

Name

Valsartan

Molecular Formula

C24H29N5O3

Molecular Weight

435.52

QualityStandard

EP/USP/JP

Package Size

25kg/drum

Brief Introduction

Valsartan (trade name Diovan) is an angiotensin II receptor antagonist
(commonly called an ARB, or angiotensin receptor blocker), that is selective
for the type I (AT1) angiotensin receptor. Valsartan is mainly used for treatment
of high blood pressure, congestive heart failure, and to increase the chances of
living longer after a heart attack.

ITEMS

STANDARDS

RESULTS

Appearance

White to almost white powder

White 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

Absorbance

NMT 0.02

0.003

Water

NMT2.0%

0.56%

Residue on ignition

NMT0.1%

0.06%

Heavy metals

NMT0.001%

Related compounds

(HPLC)

Compound A NMT1.0%

0.49%

Compound B NMT0.2%

0.08%

Compound C NMT0.1%

Undetected

Any other individual impurity NMT0.1% (excluding compound A )

0.04%

Total impurities NMT0.3% (excluding compound A )

0.20%

Residual solvents(GC)

Ethyl acetate NMT5000ppm

2820ppm

Dichloromethane NMT600ppm

Undetected

Methanol NMT3000ppm

Undetected

N,N-Dimethylformamide NMT880ppm

Undetected

Assay

98.0—102.0%

99.2%

Conclusion

The analysis results show that this batch of valsartan conforms to USP