2.6.12(新)微生物限度检测.docVIP

2.6.12.MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: MICROBIAL ENUMERATION TESTS 2．6.12.非无菌药品的微生物检测：微生物计数试验 1. INTRODUCTION 导言 The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi which may grow under aerobic conditions. 本试验用于检测在有氧条件下生长的嗜温性细菌和真菌总数。 The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes follow the instructions given below, including the number of samples to be taken, and interpret the results as st