Research on crucial quality attributes of pharmaceutical excipient egg yolk lecithin and its application on standard revision
10.19778/j.chp.2025.04.004
- VernacularTitle:药用辅料蛋黄卵磷脂关键质量属性研究及其在标准制修订中应用
- Author:
Xun ZHAO
1
;
Jianli WEI
;
Lei CHEN
;
Yaozuo YUAN
;
Mei ZHANG
Author Information
1. 江苏省食品药品监督检验研究院,南京 210019
- Publication Type:Journal Article
- Keywords:
egg yolk lecithin;
egg yolk lecithin(for injection);
quality standard;
crucial quality attributes
- From:
Drug Standards of China
2025;26(4):359-365
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To revise the quality standards of pharmaceutical excipients egg yolk lecithin and egg yolk lecithin(for injection)in Chinese Pharmacopoeia of 2025.Methods:Study on the quality of egg yolk lecithin by research on the crucial quality attributes and comparing domestic and abroad quality standards in pharmacopoeias.Results:Identification,water,residual solvents,and assay have been revised and free fatty acids has been deleted in the quality standard for egg yolk lecithin.Identification,water,residual solvents,related substances,bacterial endotoxins,and assay have been revised and free fatty acids has been deleted in the quality standard for egg yolk lecithin(for injection).Conclusion:The revised quality standards for egg yolk lecithin and egg yolk lecithin(for injection)have been included in the Chinese Pharmacopoeia of 2025,which provide data support and basis for qual-ity control and scientific supervision of egg yolk lecithin.
