Advances in analytical techniques for the determination of genotoxic impurities in pharmaceuticals
10.11665/j.issn.1000-5048.20160303
- VernacularTitle:药物中基因毒性杂质分析方法的研究进展
- Author:
Xiaoling RUAN
1
;
Xiangyuan ZHENG
;
Jie XU
;
Li DING
;
Feng ZHENG
Author Information
1. 中国药科大学药物分析教研室；中国药科大学药物质量与安全预警教育部重点实验室
- Publication Type:Journal Article
- Keywords:
genotoxic impurities;
analytical method;
alkyl halides;
alkyl sulfonates;
hydrazines;
epoxides;
acyl halides
- From:
Journal of China Pharmaceutical University
2016;47(3):267-274
- CountryChina
- Language:Chinese
-
Abstract:
Genotoxic or potentially genotoxic impurities seriously threaten people′s health, therefore, it is necessary to identify and quantify these impurities in pharmaceutical materials even at trace levels. Due to the special requirements on the sensitivity, selectivity, analyte stability and matrix effect, development of analytical methods is a challenge for the determination of genotoxic impurities. This paper reviews the recent advances in analytical methods for trace levels of commonly encountered genotoxic or potentially genotoxic impurities, including alkyl halides, alkyl sulfonates, hydrazines, epoxides and acyl halides, which would be helpful to control these impurities.
