检测项/Item
检测内容/Specification
检测结果/Result
外观
Physical appearance
白色、类白色粉末
White、or off-white powder
白色粉末
White powder
识别
Identify
核磁确认与供试样品保持一致
NHR confirmation is consistent with the test sample
与样品一致
Conformed
液相出峰保留时间与供试样品保持一致
The peak time of HPLC is consistent with the test sample
有关物质
Related substances
高效液相色谱纯度≥99.50% Purity of HPLC≥99.50%
99.85%
其他未知单杂≤0.10% Any Individual Impurity≤0.20%
0.03%
总杂质≤0.50% Total impurity≤≤0.50%
0.15%
手性纯度
Chiral Purity
手性纯度≥99.9%
NLT 99.9%
合格
Conforms
含量
Assay by HPLC
98.00%~102.00%
99.58%
灼烧残渣
Ignition residue
≤0.30%
重金属
Heavy Metals
≤20ppm
未检出/N.D
残留溶剂
Solvent residue
甲醇≤300ppm/Methanol≤300ppm
丙酮≤500ppm
乙腈≤41ppm/Acetonitrile≤41ppm
3ppm
二氯甲烷≤60ppm/Dichloromethanes60ppm
12ppm
异丙醚≤500ppm/sopropyl Ether≤500pppm
乙酸乙酯≤500ppm/Ethyl Acetates500ppm
17ppm
四氢呋喃≤72ppm/Tetrahydrofuran≤72ppm
醋酸异丙酯≤40ppm/Isopropyl acetate≤40ppm
22ppm
乙醇≤300ppm/Methanol≤300ppm
6ppm
水份/Water
≤0.50%
0.26%
内毒素/Bacterial Endotoxin
NMT0.5EU Per Mg
微生物
Microbial Limit
Total amount of aerobe:NMT1000cfu/g
Yeast&molds: NMT 100cfu/g
结论/Detection result
合格/Qualified
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