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Details:
Appearance White or almost white, crystalline powder
Solution Slightly soluble in methanol,practivally insoluble in water
Identification (1)IR: the IR spectrum is consistent with that obtained with the reference standard.
(2)HPLC: the ratio of retention time of the major peak of the internal standard of the sample solution,corresponds to that of the standard solution,as obtained in the assay.
Water ≤0.5%
Residue on ignition ≤0.1%
Heavy metal ≤10ppm
Related compounds Olmesartan: ≤0.5%max
Olmesartan medoxomil related compound A: ≤0.1%max
Olefinic impurity:≤0.6%
N-alkyl impurity:≤0.1%
Any other individual unidentified impurity:≤0.1%
Total impurities:≤1.3%
Residual solvents Acetone ≤5000ppm
Assay 98.5~101.5%(on anhydrous and solvent-free basis)