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 powder
白色粉末
White powder
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≥98.00% Purity of HPLC≥98.00%
99.79%
其他未知單雜≤0.20% Any Individual Impurity≤0.20%
0.14%
對映異構體≤0.15%/Enantiomer≤0.15%
未檢出/N.D
總雜質≤2.00% Total impurity≤2.00%
0.21%
手性純度
Chiral Purity
手性純度≥99.0%
NLT 99.0%
合格
Conforms
灼燒殘渣
Ignition residue
≤0.50%
0.22%
重金屬/Heavy Metals
≤20ppm
干燥失重/Loss on drying
0.39%
水份/Water
0.04%
結論/Detection result
合格/Qualified
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