摘要
目的建立丙泊酚原料药细菌内毒素检查方法,保证方法的合理性,满足相关药品管理法规的要求。方法参照《中国药典》2015年版通则(1143)细菌内毒素检查法,以二甲亚砜作为溶剂,采用凝胶法验证。结果符合《中国药典》2015年版验证实验的基本要求。结论该方法能作为丙泊酚原料药的细菌内毒素检查方法。
Objective To establish a test method of bacterial endotoxin of propofol API to assure its rationality and to meet the requirements of related drug management rules. Methods Referring to the test method of bacterial endotoxin listed in general rules（1143） of Chinese Pharmacopoeia（2015 version）, gel method was applied for the validation, using dimethylsulfoxide as solvent. Results The basic requirements of validation experiments listed in Chinese Pharmacopoeia（2015 version） were satisfied. Conclusion The method can be used to test bacterial endotoxin in propofol API.
出处
《食品与药品》
CAS
2016年第5期339-343,共5页
Food and Drug
