药品微生物限度检查法有效性验证实验研究

王知坚;邵惠琴;杜芸;刘咏梅

引用本文:	王知坚;邵惠琴;杜芸;刘咏梅.药品微生物限度检查法有效性验证实验研究[J].中国现代应用药学,2004,(3):211-213.
	WANG Zhi-jian,SHAO Hui-qin, DU Yun, LIU Yong-mei.Experimental study on validation of microbial limt tests[J].Chin J Mod Appl Pharm(中国现代应用药学),2004,(3):211-213.

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药品微生物限度检查法有效性验证实验研究
王知坚;邵惠琴;杜芸;刘咏梅

作者	单位
王知坚;邵惠琴;杜芸;刘咏梅

摘要:

关键词: 微生物限度检查法中国药典有效性验证

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Experimental study on validation of microbial limt tests

WANG Zhi-jian,SHAO Hui-qin, DU Yun, LIU Yong-mei

Abstract:

OBJECTIVE To establish a doable validation method for estimating the microbial limit tests in Chinese Pharmacopoeia. METHOD The validation have been tested by microbial recovery from 164 new drugs and the availability was estimated by the ratio of recov

Key words: microbial limit tests Chinese Pharmacopoeia availability validation