| X射线荧光光谱法在药品元素杂质分析中的应用 |
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| 引用本文： | 徐昕怡,刘贞,洪小栩.X射线荧光光谱法在药品元素杂质分析中的应用[J].江苏药学与临床研究,2019,27(5):368-370. |
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| 作者姓名： | 徐昕怡 刘贞 洪小栩 |
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| 作者单位： | 国家药典委员会,江西省药品检验检测研究院,国家药典委员会 |
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| 摘 要： | X射线荧光光谱（X-ray Fluorescence Spectrometry，XRF）是基于测量由初级X射线激发的原子内层壳电子产生的特征X射线光量子的一种仪器分析方法。本文介绍了XRF的分类、特点和各国药典标准，综述了国内外XRF在药品研发以及原料药、药用辅料和制剂元素杂质分析中的应用进展，以期为药品的元素杂质控制研究提供参考。
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| 关 键 词： | X射线荧光光谱法 药品 元素杂质 应用 |
| 收稿时间： | 2019/4/28 0:00:00 |
| 修稿时间： | 2019/10/11 0:00:00 |
Application of X-Ray Fluorescence Spectrometry in Analysis of Drug Elemental Impurities |
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| XU Xinyi,LIU Zhen and HONG Xiaoxu.Application of X-Ray Fluorescence Spectrometry in Analysis of Drug Elemental Impurities[J].Jiangsu Pharmacertical and Clinical Research,2019,27(5):368-370. |
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| Authors: | XU Xinyi LIU Zhen and HONG Xiaoxu |
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| Institution: | Chinese Pharmacopoeia Commission,Jiangxi Institute for Drug Control,Chinese Pharmacopoeia Commission |
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| Abstract: | X-ray fluorescence spectrometry (XRF) is an instrumental analysis method based on measuring characteristic X-ray photons generated by atomic inner shell electron excited by the primary X-rays. This paper introduces the classification, characteristics and national pharmacopoeia standards of XRF, and summarizes the research progress of XRF in the research and development of drugs and the analysis of elemental impurities in active pharmaceutical ingredients, pharmaceutical excipients and preparations, in order to provide a reference for the study of drug elemental impurity control. |
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| Keywords: | X-ray fluorescence spectrometry Medicine Elemental impurities Application |
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