Analysis of Coordination Strategies with ICH Q3C for Residual Solvent Control in Pharmacopoeia of Various Countries
10.3870/j.issn.1004-0781.2025.02.009
- VernacularTitle:各国药典标准残留溶剂控制与ICH Q3C协调策略分析
- Author:
Min CHEN
1
;
Weicong WU
;
Xinyi XU
;
Suming WANG
;
Xiao LING
;
Qiming ZHANG
;
Ying CHEN
;
Lei CHEN
Author Information
1. 广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州 510663
- Publication Type:Journal Article
- Keywords:
ICH Q3C;
Residual solvents;
Pharmacopoeia;
Coordinated strategies
- From:
Herald of Medicine
2025;44(2):227-235
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.
