Research on the Coordinated Implementation Strategy Between the Chinese Pharmacopoeia Pharmaceutical Excipient Standards and ICH Q3C
10.3870/j.issn.1004-0781.2025.02.006
- VernacularTitle:《中华人民共和国药典》药用辅料标准与ICH Q3C协调实施策略研究
- Author:
Min CHEN
1
;
Weicong WU
;
Yu SONG
;
Caimei WANG
;
Yajuan GUO
;
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:
Chinese pharmacopoeia;
ICH Q3C;
Residual solvents;
Pharmaceutical excipient standards
- From:
Herald of Medicine
2025;44(2):208-212
- CountryChina
- Language:Chinese
-
Abstract:
Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.
