Drug Standards of China 2025;26(1):051-057

doi:10.19778/j.chp.2025.01.008

The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition

CHEN Lei ; LUI Yanming ; YUAN Yaozuo ; CHEN Ying ; DAI Hong ; ZHANG Jun ; MA Shuangcheng

Keywords

Chinese Pharmacopoeia; pharmaceutical excipients; standards; revised

Country

China

Language

Chinese

Abstract

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, and the total number has reached 387. 245 pharmaceutical excipients monographs have been revised, of which 109 monographs have only textual revisions and 136 monographs have substantive revisions. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.