檢測項/Item
檢測內(nèi)容/Specification
檢測結(jié)果/Result
外觀
Physical appearance
白色、類白色至黃色粉末
White、or off-white powder
類白色粉末
off-white powder
溶解度/Solubility
易溶于二甲基亞砜、二氯甲烷
Freely soluble in DMSO、DCM
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(guān)物質(zhì)
Related substances
高效液相色譜純度≥98.00%/Purity of HPLC≥98.00%
99.75%
其他未知單雜≤0.50% /Any Individual Impurity≤0.50%
0.09%
異構(gòu)體≤0.20%/Isomer ≤ 0.20%
0.07%
總雜質(zhì)≤2.00%/Total impurity≤2.00%
0.25%
灼燒殘渣/Ignition residue
≤1.00%
0.24%
水份/Water
≤0.50%
0.11%
干燥失重/Loss on drying
≤2.00%
0.26%
結(jié)論/Detection result
合格Qualified
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