唑来膦酸原料细菌内毒素检查方法学研究
Methods for Bacterial Endotoxin Test of Zoledronic Acid
杜英硕 1丛金丽 1汪汀1
作者信息
- 1. 华润双鹤药业股份有限公司,北京 100121
- 折叠
摘要
目的:建立唑来膦酸原料细菌内毒素的检查方法.方法:依据2020年版《中国药典(四部)》附录1143建立唑来膦酸原料细菌内毒素的检测限.结果:唑来膦酸原料药在≤0.05 mg/mL时对细菌内毒素检查方法无干扰.结论:唑来膦酸原料的细菌内毒素限值可设定为10EU/g.
Abstract
Objective:lo establish a method for bacterial endotoxin test of zoledronic acid raw material.Methods:lhe detection limit of bacterial endotoxin of zoledronic acid raw material was established according to Appendix 1143 of Chinese Pharmacopoeia(Ⅳ)2020 edition.Results:Zoledronic acid had no interference with bacterial endotoxin test when the concentration was 0.05 mg/mL or less.Conclusion:The bacterial endotoxin limit of zoledronic acid raw material can be set to 10 EU/g.
关键词
唑来膦酸/细菌内毒素/鲎试剂/干扰实验Key words
zoledronic acid/bacterial endotoxin/tachypleus amebocyte lysate/interference test引用本文复制引用
出版年
2024
NETL
NSTL
万方数据