检测项/Item
检测内容/Specification
检测结果/Result
外观
Physical appearance
白色、类白色结晶性粉末
White、or off-white crystalline powder
白色结晶性粉末
White crystalline powder
溶解度/Solubility
易溶于二甲基亚砜 Freely soluble in DMSO
符合规定Complies
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≥98.50% Purity of HPLC≥98.50%
99.15%
异构体≤0.10% Isomer≤0.10%
未检出/N.D
其他未知单杂≤0.50% Any Individual Impurity≤0.50%
0.25%
总杂质≤1.50% Total impurity≤1.50%
0.85%
溶剂残留
Residual solvents
丙酮≤600ppm/Acetone≤600ppm
28ppm
二氯甲烷≤600ppm/Dichloromethanes600ppm
463ppm
乙酸乙酯≤2000ppm/Ethyl acetate≤2000ppm
3ppm
正庚烷≤2000ppm/Heptane≤2000ppm
17ppm
2.2-二甲氧基丙烷≤1000ppm
2.2-dimethoxypropane≤1000ppm
450ppm
含量/Assay by HPLC
98.00%~102.00%
99.01%
水份/Water
≤0.50%
0.14%
灼烧残渣/Ignition residue
≤0.20%
0.05%
干燥失重/Loss on drying
0.16%
结论/Detection result
合格/Qualified
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