| 奥沙利铂杂质C的制备研究 |
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| 引用本文： | 牛冲,徐志洲,李涛,李军. 奥沙利铂杂质C的制备研究[J]. 药物分析杂志, 2011, 0(7) |
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| 作者姓名： | 牛冲 徐志洲 李涛 李军 |
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| 作者单位： | 山东省药品检验所; |
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| 基金项目： | 国家科技重大专项重大新药创制-输液生产线关键工艺在线监控技术平台建设(2009ZX09313-023) |
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| 摘 要： | 目的:建立奥沙利铂杂质C的制备方法,进行结构解析并测定其含量。方法:以奥沙利铂为原料,用3%的H2O2溶液氧化制备杂质C,并采用高效液相色谱法测定其含量。结果:杂质C的产率为83%,其含量为99.5%。结论:所建的制备方法简单、快速,可用于奥沙利铂杂质C对照品的制备。
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| 关 键 词： | 奥沙利铂 杂质C 双氧水 有关物质 结构 鉴定 含量 |
Study on preparation of oxaliplatin impurity C |
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| NIU Chong,XU Zhi-zhou,LI Tao,LI Jun. Study on preparation of oxaliplatin impurity C[J]. Chinese Journal of Pharmaceutical Analysis, 2011, 0(7) |
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| Authors: | NIU Chong XU Zhi-zhou LI Tao LI Jun |
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| Affiliation: | NIU Chong,XU Zhi-zhou,LI Tao,LI Jun(Shandong Provinical Institute for Drug Control,Jinan 250101,China) |
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| Abstract: | Objective:To establish a method of preparing,structure elucidation and assay of oxilaplatin impurity C.Methods:Impurity C was synthesized with Oxaliplatin and H2O2,its content was assayed by HPLC.Results:The yield of impurity C was 83%,and its content was 99.5%.Conclusion:The method was simply and convenient,and can be used to prepare the impurity C reference substance. |
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| Keywords: | oxaliplatin impurity C H2O2 related substance sturcture identification assay |
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