檢測項/Item
檢測內容/Specification
檢測結果/Result
外觀
Physical appearance
白色、類白色結晶性粉末
White、or off-white crystalline powder
白色結晶性粉末
White crystalline powder
溶解度/Solubility
易溶于二甲基亞砜 Freely soluble in DMSO
符合規(guī)定Complies
識別
Identify
核磁確認與供試樣品保持一致
NHR confirmation is consistent with the test sample
與樣品一致
Conformed
液相出峰保留時間與供試樣品保持一致
The peak time of HPLC is consistent with the test sample
有關物質
Related substances
高效液相色譜純度≥98.50% Purity of HPLC≥98.50%
99.15%
異構體≤0.10% Isomer≤0.10%
未檢出/N.D
其他未知單雜≤0.50% Any Individual Impurity≤0.50%
0.25%
總雜質≤1.50% Total impurity≤1.50%
0.85%
溶劑殘留
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%
灼燒殘渣/Ignition residue
≤0.20%
0.05%
干燥失重/Loss on drying
0.16%
結論/Detection result
合格/Qualified
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