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 powder
类白色粉末
off-white powder
溶解度/Solubility
易溶于二甲基亚砜、二氯甲烷
Freely soluble in DMSO、DCM
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≥98.00%/Purity of HPLC≥98.00%
99.75%
其他未知单杂≤0.50% /Any Individual Impurity≤0.50%
0.09%
异构体≤0.20%/Isomer ≤ 0.20%
0.07%
总杂质≤2.00%/Total impurity≤2.00%
0.25%
灼烧残渣/Ignition residue
≤1.00%
0.24%
水份/Water
≤0.50%
0.11%
干燥失重/Loss on drying
≤2.00%
0.26%
结论/Detection result
合格Qualified
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