檢測項/Item
檢測內容/Specification
檢測結果/Result
外觀
Physical appearance
白色、類白色至黃色粉末
White、or off-white to yellow powder
白色粉末
White powder
溶解度/Solubility
易溶于二甲基亞砜
Freely soluble in DMSO
符合規(guī)定
Complies
識別/Identify
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
與樣品一致
Conformed
有關物質
Related substances
高效液相色譜純度≥99.00%/Purity of HPLC≥99.00%
99.95%
其他未知單雜≤0.30% /Any Individual Impurity≤0.30%
0.03%
總雜質≤1.00%/Total impurity≤1.00%
0.05%
含量/Assay by HPLC
98.00%~102.00%
99.66%
溶劑殘留
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%
灼燒殘渣/Ignition residue
0.11%
結論/Detection result
合格Qualified
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