Key Topics of the Japanese Pharmacopoeia (JP) 18th Edition and the Basic Principles of the JP 19th Edition

Abstract

The Japanese Pharmacopoeia (JP) 18^th edition was published on June 7, 2021 and its key topics are as follows: (1) implementation of ICH-Q3D; (2) 33 new monographs, (3) one new and five revised general tests; (4) seven new general information; and (5) removal of harmful reagents, and use of the word “enantiomer” instead of “optical isomer;” (6) removal of some alias names (commonly used names), and revision of several titles. This article summarizes the above key topics. In addition, the difference in the basic principles for the preparation of the JP 18^th edition and those of the JP 19^th edition, which was announced on September 2, 2021, are presented.