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
溶解度/Solubility
易溶于二甲基亚砜
Freely soluble in DMSO
符合规定
Complies
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
高效液相色谱纯度≥99.00%/Purity of HPLC≥99.00%
99.95%
其他未知单杂≤0.30% /Any Individual Impurity≤0.30%
0.03%
总杂质≤1.00%/Total impurity≤1.00%
0.05%
含量/Assay by HPLC
98.00%~102.00%
99.66%
溶剂残留
Residual solvents
乙醇≤5000ppm/Ethanol ≤5000ppm
234ppm
甲醇≤3000ppm/Methanol≤3000ppm
210ppm
水份/Water
≤0.50%
干燥失重/Loss on drying
0.41%
灼烧残渣/Ignition residue
0.11%
结论/Detection result
合格Qualified
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