Appearance White or whitish crystalline powder White crystalline powder High-performance liquid chromatograph HPLC The retention time of test sample major peak complies to reference standard Conforms IR-infrared spectrum The retention time of test sample major peak complies to reference standard Conforms Loss on drying 1.0% 0.5% Residue on ignition 0.1% 0.06% Related impurity Total impurities:1.0% 0.59% Single impurity:0.5% Conforms Ethyl acetate 0.5% Conforms Heavy metals 20ppm <20ppm Purity 98.5% 99.41%
