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| ReviewsResearch Progress on Detection Techniques for Elemental Impurities in Drugs |
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| DOI： |
| KeyWord:drug elemental impurities analytical techniques review |
| Author | Institution |
| ZHU Li,ZHAO Yu,YAO Shang-chen,XU Ming-zhe，YIN Li-hui,HU Chang-qin |
National Institutes for Food and Drug Control |
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| 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 Chinas 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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