Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
10.19778/j.chp.2025.01.007
- VernacularTitle:2025年版《中国药典》四部理化分析通用技术要求增修订概况
- Author:
XU Xinyi
;
WEI Shifeng
;
ZHANG Qiming
;
HE Langchong
;
ZHANG Jun
;
MA Shuangcheng
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
physical and chemical analysis;
general chapter;
additions and revisions
- From:
Drug Standards of China
2025;26(1):045-050
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.
- Full text:202503111407598434720250207.pdf
