摘要
建立了原料药维生素C的微生物限度检查法,包括细菌数、霉菌及酵母菌数及控制菌的检查。样品采用药典规定的常规法、薄膜过滤法进行微生物限度方法学验证,在进行控制菌-大肠菌群方法验证时,采用碳酸钠中和样品酸性,来进行检测方法验证。
A microbiological test method was established for Vitamin C pharmaceutical preparations： total viable aerobic count（including total aerobic microbial count and total combined yeasts/mould count） and test for specified micro-orga-nisms.Two kinds of methods were used as the normal regulation method and the membrane filtration method for validation of microbiological test,and test for coliform used the neutrality by the sodium carbonate for validation of microbiological test.
出处
《河北化工》
2011年第4期23-24,共2页
Hebei Chemical Industry
关键词
维生素C
维生物检查
方法验证
常规法
薄膜过滤法
Vitamin C
microbiological test
method demonstrate
normal regulation method
the membrane filtration method
