Advances on genotoxic impurities of sulfonate esters in pharmaceuticals
文献类型：期刊论文
| 作者 | Liu, Xuewei1; Li, Cheng2; Han, Haiyun1; Zhang, Wenpeng1; Chen, Dongying1
|
| 刊名 | Se pu = Chinese journal of chromatography
 |
| 出版日期 | 2018-10-08 |
| 卷号 | 36期号:10页码:952-961 |
| ISSN号 | 1000-8713 |
| DOI | 10.3724/SP.J.1123.2018.05004 |
| 文献子类 | Meeting Abstract;Article |
| 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. |
| 语种 | 中文 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/266750]  |
| 专题 | 药物质量控制与固体化学研究中心 |
| 作者单位 | 1.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; 2.Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China |
| 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]. Se pu = 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.Se pu = Chinese journal of chromatography,36(10),952-961. |
| MLA | Liu, Xuewei,et al."Advances on genotoxic impurities of sulfonate esters in pharmaceuticals".Se pu = 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
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