检测项/Item
检测内容/Specification
检测结果/Result
外观
Physical appearance
白色、类白色至黄色粉末
White、or off-white to yellow powder
白色粉末
White Powder
灼烧残渣
Ignition residue
≤1.00%
0.25%
识别
Identify
液相出峰保留时间与供试样品保持一致
The peak time of HPLC is consistent with the test sample
与样品一致
Conformed
有关物质
Related substances
对映异构体≤0.15%/Enantiomer≤0.15%
未检出/N.D
非对应异构体≤1.00%/Non corresponding isomer≤1.00%
0.19%
高效液相色谱纯度≥98.00%/Purity of HPLC≥98.00%
99.75%
单杂≤1.00%/Max Single Impurity≤1.00%
0.03%
总杂质≤1.50%/Total impurity≤1.50%
含量/Assay by HPLC
98.00%~102.00%
99.14%
水份 /Water
0.31%
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