Research on Residual Solvent Control of Pectin Standard for Pharmaceutical Excipients in the Chinese Pharmacopoeia Based on ICH Q3C Coordination
10.3870/j.issn.1004-0781.2025.02.010
- VernacularTitle:基于ICH Q3C协调的《中华人民共和国药典》药用辅料果胶标准中残留溶剂控制
- Author:
Weicong WU
1
;
Sixiang LIN
1
;
Yajuan GUO
1
;
Caimei WANG
1
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:
Pectin;
Residual solvents;
ICH Q3C;
Chinese pharmacopoeia
- From:
Herald of Medicine
2025;44(2):235-238
- CountryChina
- Language:Chinese
-
Abstract:
Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.
