项目Item 测试标准Test Criterion 结果Result 外观Appearance 白色结晶粉末 white crystalline powder Conforms 含量Assay Min 99.0% 99.4% 比旋度Specific Rotation 31 o to 32o (C=1, H2O 24 oC) 31.6° 干燥失重Loss on drying ≤0.30% 0.09% 其他氨基酸Other amino acids(HPLC) Max 0.01% Conforms PH value 5.4-6.4 6.1 灼烧残渣Residue on ignition ≤0.10% 0.03% Chloride(Cl) ≤0.020% <0.020% Ammonium(NH4) ≤0.020% <0.020% Sulfate(SO4) ≤0.020% <0.020% Iron(Fe) ≤20ppm <20ppm Heavy metals(Pb) ≤10ppm <10ppm Arsenic(As2O3) ≤1ppm <1ppm