磷酸左奥硝唑酯二钠细菌内毒素检测方法验证  

Validation of Bacterial Endotoxin Testing Method for Levoornidazole Phosphate Disodium

作　　者：杨晨 谢益晖 王贺 顾德周 王林[1] Yang Chen;Xie Yihui;Wang He;Gu Dezhou;Wang Lin(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225321,China)

机构地区：[1]扬子江药业集团

出　　处：《中国药事》2019年第8期944-948,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:建立磷酸左奥硝唑酯二钠细菌内毒素的常规检测方法。方法:按《中华人民共和国药典》2015年版通则1143细菌内毒素检查法进行。结果:在验证条件下,样品原液稀释至6.25 mg·mL^-1时,对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查磷酸左奥硝唑酯二钠的细菌内毒素可行。Objective: To establish a conventional bacterial endotoxin testing method for levoornidazole phosphate disodium. Methods: The test method was carried out according to the bacterial endotoxin testing method of general rule 1143 in the Chinese Pharmacopoeia of 2015 edition. Results: Under the validation condition, the sample stock solution diluted to 6.25 mg·mL^-1 did not interfere with the bacterial endotoxin testing. Conclusion: The established method can be used for bacterial endotoxin testing of levoornidazole phosphate disodium.

关 键 词：磷酸左奥硝唑酯二钠 细菌内毒素 凝胶法 干扰试验 

分 类 号：R927.1[医药卫生—药学]