High Purity Anti Hypertensive Drugs Irbesartan for Hypertension Treatment,CAS:138402-11-6 CAS NO.138402-11-6

item of testing

inspection standard

result

appearance

white to off-white, crystalline 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

water

nmt 0.5%

0.31%

limit of azide

nmt 10ppm

not detected

heavy metals

nmt 0.002%

conforms

related compounds

compound a nmt 0.2%

0.02%

any other impurity nmt 0.1%

0.04%

total impurities nmt 0.5%

0.09%

residual solvents(gc)

ethanol nmt 5000ppm

26ppm

toluene nmt 890ppm

133ppm

t-butyl methyl ether nmt 5000ppm

not detected

assay(on the anhydrous basis)

98.0~102.0%

99.3%

conclusion

the analysis results show that this batch

of irbesartan conform