项目Item 检测标准Test Criterion 结果Result 外观Appearance 白色结晶粉末 white crystalline powder 符合Conforms 含量Assay min 98.0% 99.32% Identification(by IR) Must be comparable to the standard specturm run under the same conditions. conform 干燥失重Loss on drying max 0.5% 0.2% 灼烧残渣Residue on Ignition max 0.4% 0.2% N-Acetyl-L-tert-Leucine Not more than 0.05% ND L-MOC-Dimer Not more than 0.3% Less than 0.01% Any other individual impurity Not more than 0.1% 0.07% Total impurity Not more than2.0% 0.7% R-enantiomer Not more than 0.2% Less than 0.01%