檢測項(xiàng)/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 to yellow powder
白色粉末
White Powder
灼燒殘?jiān)?/span>
Ignition residue
≤1.00%
0.25%
識(shí)別
Identify
液相出峰保留時(shí)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
對映異構(gòu)體≤0.15%/Enantiomer≤0.15%
未檢出/N.D
非對應(yīng)異構(gòu)體≤1.00%/Non corresponding isomer≤1.00%
0.19%
高效液相色譜純度≥98.00%/Purity of HPLC≥98.00%
99.75%
單雜≤1.00%/Max Single Impurity≤1.00%
0.03%
總雜質(zhì)≤1.50%/Total impurity≤1.50%
含量/Assay by HPLC
98.00%~102.00%
99.14%
水份 /Water
0.31%
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