| 化学药物杂质研究进展 |
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| 引用本文： | 岳悦.化学药物杂质研究进展[J].微生物学杂志,2015(7). |
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| 作者姓名： | 岳悦 |
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| 作者单位： | 1. 中国药科大学分析化学教研室，江苏 南京 210009；2. 南京卡文迪许生物工程技术有限公司，江苏 南京 210033 |
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| 摘 要： | 药物杂质的分析和控制是用药安全有效的基础。从杂质谱分析、杂质检测、杂质限度的制定等方面综述了近年来国内外化学药
物杂质研究进展，旨在为化学药物杂质的研究提供有效思路和方法。
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| 关 键 词： | 杂质谱 杂质检测 杂质限度 有关物质 手性杂质 遗传毒性杂质 |
A dvances in Researches on Impurities in Chemical
Drugs |
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| YUE Yue.A dvances in Researches on Impurities in Chemical
Drugs[J].Journal of Microbiology,2015(7). |
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| Authors: | YUE Yue |
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| Institution: | 1. Department of Analytical Chemistry, China Pharmaceutical University, Nanjing 210009, China; 2. Nanjing Cavendish Bio-Engineering
Technology Co., Ltd., Nanjing 210033, China |
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| Abstract: | Analysis and control of drug impurities are the basics for effective and safe use of drugs. This paper reviews the advances in researches
on impurities in chemical drugs from the aspects of impurity profiling, impurity detection and formulation of impurity limit, so as to provide
constructive ideas and effective methods for researches on impurities in chemical drugs. |
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| Keywords: | impurity profile impurity detection impurity limit related substance chiral impurity genotoxic impurity |
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