Advances on genotoxic impurities of sulfonate esters in pharmaceuticals
文献类型：期刊论文
| 作者 | Liu Xuewei4; Li Cheng3; Han Haiyun2; Zhang Wenpeng4; Chen Dongying4
|
| 刊名 | Chinese Journal of Chromatography
 |
| 出版日期 | 2018 |
| 卷号 | 36期号:10页码:952-961 |
| ISSN号 | 1000-8713 |
| 关键词 | genotoxic impurity sulfonate ester control strategy chromatographic method review |
| 其他题名 | 药物中磺酸酯类基因毒性杂质研究进展 |
| 文献子类 | Review |
| 英文摘要 | This article reviews the refinement of regulatory guidelines and progress of research on the control of genotoxic impurities in pharmaceuticals in the last decade. It outlines advances in the regulatory requirements for genotoxic impurities from strict avoidance to the currently accepted concept of threshold of toxicological concern (TTC), which is based on risk control considerations. Specific control limits, which are required by predominant administrative regulatory agencies, such as U. S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), etc. Sulfonate esters, an important class of potential genotoxic impurities, are usually generated by side-reactions between sulfonic acids or their derivatives and relative low molecular mass alcohols, such as methanol, ethanol, and isopropanol. The resulting sulfonate esters are characterized with diverse chemical structures. Reaction mechanisms of the formation of sulfonate esters and various strategies to control them have been schematically described. A detailed summary has been given for the analytical methodology developed using high performance liquid chromatography (HPLC) and gas chromatography (GC) to determine trace amounts of sulfonate esters in pharmaceuticals. Furthermore, we have comprehensively discussed the options for the chromatographic methods, sample pretreatments, and derivatization methods, as well as each method's sensitivity and recovery at trace level. This review intended to provide constructive suggestions for the rational control of sulfonate esters in pharmaceuticals to ensure their clinical safety. |
| 资助项目 | 中国科学院药物创新研究院自主部署科研项目[00000000] |
| WOS研究方向 | Chemistry (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:6345412 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/269153]  |
| 专题 | 药物质量控制与固体化学研究中心 |
| 通讯作者 | Chen Dongying |
| 作者单位 | 1.; 2.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China. 3.Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China.; 4.Shanghai Institute of Materia Medica, Chinese Academy of Sciences; 5.Shanghai; |
| 推荐引用方式 GB/T 7714 | Liu Xuewei,Li Cheng,Han Haiyun,et al. Advances on genotoxic impurities of sulfonate esters in pharmaceuticals[J]. Chinese Journal of Chromatography,2018,36(10):952-961. |
| APA | Liu Xuewei,Li Cheng,Han Haiyun,Zhang Wenpeng,&Chen Dongying.(2018).Advances on genotoxic impurities of sulfonate esters in pharmaceuticals.Chinese Journal of Chromatography,36(10),952-961. |
| MLA | Liu Xuewei,et al."Advances on genotoxic impurities of sulfonate esters in pharmaceuticals".Chinese Journal of Chromatography 36.10(2018):952-961. |
入库方式： OAI收割
来源：上海药物研究所
浏览0
下载0
收藏0
其他版本
除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。