检测项/Item
检测内容/Specification
检测结果/Result
外观
Physical appearance
白色、类白色粉末
White、or off-white powder
白色粉末
White powder
识别
Identify
核磁确认与供试样品保持一致
NHR confirmation is consistent with the test sample
与样品一致
Conformed
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
有关物质
Related substances
高效液相色谱纯度≥98.00% Purity of HPLC≥98.00%
99.86%
其他未知单杂≤0.20% Any Individual Impurity≤0.20%
0.08%
总杂质≤2.00% Total impurity≤2.00%
0.14%
手性纯度
Chiral Purity
手性纯度≥99.0%
NLT 99.0%
合格
Conforms
灼烧残渣Ignition residue
≤0.50%
0.05%
比旋度/Specific rotation
-15°~-20°
-17.4°
重金属/Heavy Metals
≤20ppm
未检出/N.D
干燥失重/Loss on drying
≤1.00%
0.19%
水份/Water
0.26%
结论/Detection result
合格/Qualified
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