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
≤0.50%
0.07%
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
对映异构体≤0.30%/Enantiomer≤0.30%
0.08%
高效液相色谱纯度≥99.00%/Purity of HPLC≥99.00%
99.80%
单杂≤0.30%/Max Single Impurity≤0.30%
0.06%
总杂质≤1.00%/Total impurity≤1.00%
0.20%
含量/Assay by HPLC
98.00%~102.00%
99.14%
溶剂残留
Residual solvents
乙醇≤6000ppm/Methanol≤6000ppm
178ppm
二氯甲烷≤600ppm/Dichloromethanes600ppm
98ppm
乙酸乙酯≤5000ppm/Ethyl Acetates5000ppm
670ppm
四氢呋喃≤720ppm/Tetrahydrofuran≤720ppm
200ppm
甲基叔丁基醚≤720ppm/Methyl tert butyl ether≤720ppm
179ppm
水份 /Water
重金属/Heavy Metals
≤20ppm
未检出/N.D
结论/Detection result
合格/Qualified
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