EP8.0–2.6.13非无菌药品的微生物限度检查：特殊微生物的检查(中英对照).docVIP

EP 8.0 04/2010:20613 2.6.13. MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3) 非无菌药品的微生物限度检查：特殊微生物的检查 1. INTRODUCTION 导言 The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. 下述检验方法用于检在试验条件下特定微生物限度。 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