摘要
本文建立复方氨酚烷胺制剂的微生物限度检查方法。按《中国药典》2005年版微生物限度检查法进行验证和试验。经方法学验证试验得出的检查方法可用于复方氨酚烷胺片剂、胶囊剂和颗粒剂的微生物限度检查。
The method of microbial limit test for compound paracetamol and amantadine hydrochloride preparations was established according to microbial limit test method, Appendix XI J, Edition 2005 of Chinese Pharmacoepia. The validation results showed that the method can be used for microbial limit test of compound paracetamol and amantadine hydrochloride tablets and capsules.
出处
《中国药事》
CAS
2006年第12期739-741,共3页
Chinese Pharmaceutical Affairs
关键词
复方氨酚烷胺制剂
微生物限度检查
验证
compound paraeetamol and amantadine hydrochloride preparations
microbial limit test
validation tests
