美国药典USP3171无菌检查法双语版.pdfVIP

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 t