美国药典USP31NF26无菌检查法.docVIP

美国药典USP31-NF26无菌检查法《71》.doc 71 STERILITY TESTS 无菌检查法 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols ( ) to specify this fact. 此通则的各部分已经与欧洲药典和/或日本药典的对应部分做了协调。不一致的部分用符号（ ）来标明。 ? The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. Pharmacopeial articles are to be teste