2014年英国药典.docxVIP

Appendix XVI B. Microbiological Examination of Non-sterile Products1. Test for Specified Micro-organisms1(Ph. Eur. method 2.6.13)1 INTRODUCTIONThe tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described.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 re