Appearance White to yellow powder Off-white powder Identification IR: The IR absorption spectrum of the sample must be concordant with Test Standard Conforms HPLC: The HPLC spectrum of the sample be concordant with the standard substance Conforms Related Substances Any other impurity: NMT 0.3% 0.27% Total impurities: NMT 1.0% 0.57% Residual Solvents Meets current ICH requirement Conforms Residue on ignition Not more than 0.2% Conforms Heavy Metals Not more than 20ppm Conforms Assay (basis on anhydrous) 98.0% ~ 102.0% 99.1%