Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.11.008
- VernacularTitle:2025年版《中华人民共和国药典》光散射法测定粒度通则修订与应用
- Author:
Hui WU
1
;
Baoxi ZHANG
;
Ping ZHENG
;
Yongjian YANG
;
Qiaoru XUE
;
Yihong LU
;
Xuefan CHEN
;
Langui XIE
;
Xia ZHAO
Author Information
1. 中国食品药品检定研究院,北京 100050;药品监管科学全国重点实验室,北京 100050
- Publication Type:Journal Article
- Keywords:
The Pharmacopoeia of the People's Republic of China;
Light scattering method;
Particle size;
Revision
- From:
Herald of Medicine
2025;44(11):1773-1778
- CountryChina
- Language:Chinese
-
Abstract:
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
