Investigation of quality standard of purified siliceous earth for pharmaceutical excipients
10.19778/j.chp.2025.02.002
- VernacularTitle:药用辅料硅藻土质量标准的研究
- Author:
Tian TIAN
1
;
Shu ZHOU
;
Yanyun LIU
;
Xiaobei ZHENG
;
Yan JIANG
Author Information
1. 湖北省药品监督检验研究院,武汉 430075;湖北省药品质量检测与控制工程技术研究中心,武汉 430075
- Publication Type:Journal Article
- Keywords:
purified siliceous earth;
quality standard;
project revision;
content determination;
soluble aluminum
- From:
Drug Standards of China
2025;26(2):122-127
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To revise the quality standards of purified siliceous earth in the Chinese Pharmacopoeia 2020 Vol Ⅳ.Methods:Referring to USP2024 and GB 14936-2012 food additive purified siliceous earth and related ref-erences,the current quality standards for pharmaceutical excipient purified siliceous earth were revised,including description,dissolved substances in water,dissolved substances in acid,and content determination.The soluble a-luminum content was also investigated.Results:Revised the description of characteristic items,methods for deter-mining dissolved substances in water and acid,and limits for content determination;Through the investigation of soluble aluminum before and after filtration of human serum albumin(HSA)samples using purified siliceous earth as a filter aid,it is shown that purified siliceous earth has a certain degree of adsorption effect on aluminum ele-ment.At present,the use of low-temperature ethanol ultrafiltration process does not increase the residual aluminum content in biological products,so an aluminum element determination item is not added to the standard.Conclusion:The comprehensive quality standards for purified siliceous earth will be included in the Chinese Phar-macopoeia 2025 edition,providing strong technical support for the quality and safety supervision of this product.
