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

作　　者：杜英硕 丛金丽 汪汀 Du Yingshuo;Cong Jinli;Wang Ting(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100121,China)

机构地区：[1]华润双鹤药业股份有限公司,北京100121

出　　处：《山西化工》2024年第5期103-104,共2页Shanxi Chemical Industry

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/m L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10 EU/g。Objective:To establish a method for bacterial endotoxin test of zoledronic acid raw material.Methods:The 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/m L 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 

分 类 号：R917[医药卫生—药物分析学]