ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs

朱俐; 赵瑜; 姚尚辰; 许明哲; 尹利辉; 胡昌勤

doi:doi：10.3969/j.issn.1004-4957.2020.04.019

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ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs

更新时间：2023-04-18

- ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs
- Vol. 39, Issue 4, Pages: 547-554(2020)
- 作者机构：
  
  中国食品药品检定研究院
- 作者简介：
- 基金信息：
- DOI：doi：10.3969/j.issn.1004-4957.2020.04.019
  CLC：
- Published：2020
- 稿件说明：
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朱俐, 赵瑜, 姚尚辰, 许明哲, 尹利辉, 胡昌勤. ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs[J]. 2020, 39(4): 547-554.
DOI：

朱俐, 赵瑜, 姚尚辰, 许明哲, 尹利辉, 胡昌勤. ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs[J]. 2020, 39(4): 547-554. DOI： doi：10.3969/j.issn.1004-4957.2020.04.019.

摘要

元素杂质的控制一直是药物研发过程中的重要问题，某些元素杂质不仅会对药物的稳定性、保质期产生不利影响，还可能因为潜在的毒性引发药物副作用。欧盟和美国对元素杂质的控制越来越严格，USP<232>、USP<233>、ICH Q3D对元素杂质的分类和控制都提出了新的要求，中国于2017年6月加入ICH后对此项目的检测也应向国际靠拢，因此建立有效的检测方法尤其重要。该文从样品制备、元素杂质的快速筛查方法及仪器分析方法等方面介绍了近年来药物中元素杂质分析的最新进展，以期为药品中的元素杂质分析提供理论支持和技术参考。

Abstract

Control of elemental impurities has always been an important issue in the research and development for drugs.Some elemental impurities may not only adversely affect the stability and shelf life of a drug

but also cause side-effects of the drug due to its potential toxicity.The European Union and the United States are increasingly stricter on the control of elemental impurities.New requirements in USP<232>

USP<233> and ICH Q3D have been put forward for the classification and control of elemental impurities.Therefore

the detection for this item after Chinas entry into the ICH should also be closer to that of the international community

ant it is especially important to establish an effective testing method.In this paper

the recent progress in the analysis techniques for elemental impurities in drugs is introduced from the aspects of sample preparation

rapid screening and instrumental analysis

anticipating to provide a theoretical support and a technical reference for the analysis of elemental impurities in pharmaceuticals.

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