L-5-甲基四氢叶酸钙液相分析方法验证
依据2015版中华人民共和国药典第四部通则中《9101药品质量标准分析方法验证指导原则》的要求，对L-5-甲基四氢叶酸钙液相分析方法进行了验证,结论：检出限为0.015μg/mL，定量限为0.05，μg/mL，RSD为0.31%，加标回收率范围97.3%-114%，方法适用。
the method of liquid phase analysis of L-5-methyltetrahydrofolate was verified according to the requirements of the "Guidelines for Validation of the Standard Analysis Method for Drug Quality 9101" in the fourth edition of the 2015 edition of the Pharmacopoeia of the People's Republic of China. Result: The detection limit was 0.015μg/mL, the quantitative limit was 0.015μg/mL, the RSD was 0.31%,the recoveries was in the range of 97.3-114%.
标题：L-5-甲基四氢叶酸钙液相分析方法验证
英文标题：Application of HPLC mathematical statistics in Calcium L-5-Methyltetrahydrofolate
作者：
陈煜 南通市食品药品监督检验中心
蒋林惠 南通市食品药品监督检验中心
中文关键词:L-5-甲基四氢叶酸，液相色谱法，分析方法验证,
英文关键词:Calcium L-5-Methyltetrahydrofolate,Liquid chromatography,Analysis method validation,
发表日期：2018-12-14
- 文件大小:
- 466.69 KB
- 下载次数:
- 60
-
高速下载
|
|
