摘要
目的建立丙泊酚原料药微生物限度检查方法,保证方法的合理性和适用性。方法参照《中国药典》2010年版二部附录微生物限度检查法,添加聚山梨酯80作为乳化剂,采用薄膜过滤法验证。结果符合《中国药典》2010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微生物限度检查方法。
Objective To establish a method for microbial limit test of propofol API and ensure the rationality and applicability of this method. Methods Refering to the appendix ＂microbial limit test method＂ listed in Chinese Pharmacopoeia of 2010 version （CP2010）, the membrane-filter method with polysorbate 80 as emulsifier was used for counting of the bacteria, molds and yeasts. Results The method can meet the requirement listed in CP2010 version. Conclusion This method can be used as microbial limit method for propofol API.
出处
《食品与药品》
CAS
2015年第6期430-434,共5页
Food and Drug
