Character White to off white crystalline powder, slightly soluble in alcohol and in methylene chloride, practically insoluble in water
Identification A) IR spectrum is in accordance with the spectrum obtained with Irbesartan RS
B) The retention time of the major peak in the chromatogram of the assay corresponds to Irbesartan RS.
Water 0.5% max
metals 0.002% max
Residue on ignition 0.1% max
Related substances(HPLC)
USP Impurity A
Any unidentified impurity
Total impurity
0.2% max
0.1% max
0.5% max
Organic volatile impurities Meets the requirements of USP
Residual azide 10ppm max
Assay 98.0~102.0%(calculated on anhydrous basis)
