| 可提取物和浸出物定性定量分析方法的发展近况 |
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| 引用本文： | 翟小语,张毅兰.可提取物和浸出物定性定量分析方法的发展近况[J].中国医药工业杂志,2020(4):461-466. |
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| 作者姓名： | 翟小语 张毅兰 |
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| 作者单位： | 中国医药工业研究总院上海医药工业研究院 |
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| 摘 要： | 药品包装材料可提取物和浸出物研究是相容性研究的重要组成部分。可提取物和浸出物是一种包含痕量挥发物、半挥发物、不挥发性物及痕量元素杂质的复杂样品,必须使用正交、专属、灵敏的分析方法进行全面分析。本文系统介绍了可提取物和浸出物的来源、色谱质谱联用技术在分析可提取物和浸出物中的应用,以及未知物的鉴定策略。
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| 关 键 词： | 可提取物和浸出物 色谱质谱联用技术 高分辨质谱 未知物分析 综述 |
Recent Development in Qualitative and Quantitative Analysis Methods for Extractables and Leachables |
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| Authors: | ZHAI Xiaoyu ZHANG Yilan |
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| Institution: | (CFDA Research and Inspection Center of Pharmaceutical Packaging Materials,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203) |
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| Abstract: | Extractables and leachables study on drug packaging materials is an important part of compatibility research.A sample of extractables and leachables is a complex system containing trace amounts of volatiles,semivolatiles,non-volatiles and trace element impurities,which should be performed using orthogonal,proprietary,and sensitive analytical methods to analyze thoroughly.This paper systematically describes the sources of extractables and leachables,the application of chromatographic mass spectrometry on the study of extractables and leachables,and the strategy of unknown compound identification. |
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| Keywords: | extractables and leachables chromatographic mass spectrometry high resolution mass spectrometry unknown compound analysis review |
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