项目Item 测试标准Test Criterion 结果Result 外观Appearance white crystalline powder white crystalline powder 鉴别Identification(HPLC) HPLC 测试时,样品制备色谱图的 主峰的保留时间与标准溶液色谱图 中的主峰的保持时间一致。 The retention time of the principal peak in the chromatogram of sample preparation corresponds to that of the principal peak in the chromatogram of the standard solution,as obtained in the test of assay by HPLC. conforms 纯度Purity(HPLC) min 99.0% 99.91% 干燥失重Loss on drying max 0.5% 0.20% Checker: Che Shengli Director: Chen jian