文章摘要
郝翔.富马酸伊布利特注射液细菌内毒素检查法研究[J].中国药品标准,2019,(4):356-359
富马酸伊布利特注射液细菌内毒素检查法研究
Study on the bacterial endotoxins test method for Ibutilide Fumarate Injection
投稿时间:2019-01-24  修订日期:2019-06-24
DOI:
中文关键词: 富马酸伊布利特注射液  细菌内毒素  凝胶法  干扰实验
英文关键词: Ibutilide Fumarate Injection  bacterial endotoxin  gel method  interference test
基金项目:
作者单位E-mail
郝翔 徐州市食品药品监督检验中心 110806448@qq.com 
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中文摘要:
      目的:建立富马酸伊布利特注射液的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则进行实验和结果判断。结果:富马酸伊布利特注射液稀释10倍时对细菌内毒素检查无干扰,细菌内毒素限值为25 EU.mg-1。对3批富马酸伊布利特注射液进行常规检查,结果均符合规定。结论:所建立的细菌内毒素检查法可用于富马酸伊布利特注射液的细菌内毒素检查。
英文摘要:
      Objective:To establish a bacterial endotoxins test method for Ibutilide Fumarate Injection. Methods:The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 Vol Ⅳ. Results: There was no interference on bacterial endotoxins test when Ibutilide Fumarate Injection was diluted for 10 times. The limit value of the bacterial endotoxin was 25 EU.mg-1. The test results of bacterial endotoxin in 3 batches of samples met the criteria. Conclusion: The established method can be used for bacterial endotoxin test for Ibutilide Fumarate Injection.
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