USP（62）-非无菌产品的微生物检验特定微生物的试验.pdfVIP

Printed on: Thu Mar 21 2019, 09:55:56 am Printed by: John Schlemmer Currently Ocial as of: 21-Mar-2019 Ocial Prior to 2013 DocId: GUID-A68DE4C6-A898-490B-8198-C9FE1ADF1B60_1_en-US Printed from: /uspnf/document/GUID-A68DE4C6-A898-490B-8198-C9FE1ADF1B60_1_en-US?highlight=62 © 2019 USPC 〈 62〉 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS INTRODUCTION The tests described hereafter will allow determination of the absence of, or limited occurrence of, specied microorganisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specication 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 stated below. Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated. GENERAL PROCEDURES The preparation of samples is carried out as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 〈61〉. If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralized as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 〈61〉. If surface-active substances are used for sample preparation, their absence of toxicity for microorganisms and their compatibility with any inactivators used must be demonstrated as described in Microbiological Examination o