项目Item 测试标准Test Criterion 结果Result 外观Appearance 白色结晶粉末 White crystal powder 符合Conforms 含量Assay 99.0%~101% 99.30% 比旋度Specific rotation -11.0° to -9.0° (C=5, H2O) -9.55° 光学纯度Optical Purity NLT 99.5% 99.83% 氯Chloride (Cl) NMT 0.02% 符合Conforms 重金属Heavy Metals (Pb) NMT 15ppm 符合Conforms 干燥失重Loss on drying max 0.2% 0.02% 灼烧残渣Residue on ignition max 0.30% 0.06% 非动物源性Non- animal origin 符合Conforms 符合Conforms