[On the revision of microbial tests in the Pharmacopoeia of Japan].

Abstract

Revision of microbial tests in the Pharmacopoeia of Japan has been in progress since 1992. The affected areas include sterility tests, microbial limit tests, antimicrobial preservatives-effectiveness, and methods for strilization. Here, the revision of sterility tests, as well as of microbial limit tests, is discussed in detail. Several problems in JPXII are also described.