摘要
目的:建立枸橼酸的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则要求,使用两个厂家的鲎试剂进行细菌内毒素干扰试验预试验和干扰试验,并对样品进行细菌内毒素检查。结果:枸橼酸浓度在0.25 mg·mL^(-1)及以下时对细菌内毒素检查无干扰,细菌在毒素限值定为0.50EU·mg^(-1)(按干燥品计)。对6批样品进行检查,结果均符合规定。结论:所建立的细菌内毒素检查法(凝胶法)可用于枸橼酸的细菌内毒素检查。
Objective:To establish a bacterial endotoxins test method for citric acid.Methods:The interference pre-test and interference test of bacterial endotoxins were performed with TALs from two manufacturers,and the bacterial endotoxins of samples were tested and the results were judged according to general notices of the Chinese Pharmacopeia 2020 Volume IV.Results:There was no interference on bacterial endotoxins test when the concentration of citric acid was not more than 0.25mg·mL^(-1).The limit value of the bacterial endotoxins was set as 0.50 EU·mg^(-1)(anhydrous substance).The test results of bacterial endotoxins in 6 batches of samples met the criteria.Conclusion:The established method(gel method)can be used for bacterial endotoxin test of citric acid.
作者
陈薪宇
曹春然
孙圆媛
CHEN Xinyu;CAO Chunran;SUN Yuanyuan(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)
出处
《中国药品标准》
CAS
2021年第1期61-66,共6页
Drug Standards of China
关键词
枸橼酸
细菌内毒素
凝胶法
citric acid
bacterial endotoxins test
gel method
