Investigation on the quality standard of oleic acid for pharmaceutical excipients
10.19778/j.chp.2025.02.003
- VernacularTitle:药用辅料油酸的质量标准研究
- Author:
Ying SHI
1
;
Juan ZHANG
;
Lei CHEN
Author Information
1. 广州市药品检验所,广东省药品监督管理局缓控释制剂质量分析重点实验室,广州 510160
- Publication Type:Journal Article
- Keywords:
oleic acid;
pharmaceutical excipients;
quality standard;
assay
- From:
Drug Standards of China
2025;26(2):128-134
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish scientific and standardized quality standards for oleic acid to strengthen its quality control and ensure drug safety.Methods:Through a systematic comparison of domestic and international quality standards for oleic acid,combined with multi-batch sample testing data,key parameters such as fatty acid composition and assay were comprehensively investigated.Reasonable quality specification limits were proposed based on analysis.Results:The drafted quality standard for oleic acid includes more than ten critical tests.Innova-tively,the limits for fatty acid composition and assay were graded according to the labeled percentage content of ole-ic acid,reflecting the scientific and applicable nature of the quality standard.Conclusion:The quality standard established in this study fills a domestic gap and provides important technical support for the quality control of oleic acid as a pharmaceutical excipient and drug safety.It holds positive significance for enhancing China's pharmaceuti-cal quality standard system.
