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The use of glutathione as a derivatising agent for the analysis of Michael acceptor genotoxic impurities in pharmaceuticals

机译:使用谷胱甘肽作为用于分析药物中迈克尔受体遗传毒性杂质的衍生剂

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摘要

This work describes the development strategy and validation of an analytical method to determine trace levels of a genotoxic impurity, pyranone 2, in a pharmaceutical intermediate. A specific sensitive method capable of determining part per million (ppm) levels of this genotoxic impurity was required. The approach taken exploits the inherent Michael-acceptor reactivity present within the pyranone, utilising a novel derivatisation with glutathione followed by quantitative LC-MS/MS analysis or an LC-MS limit test. The methods have been demonstrated to be suitable to determine trace levels of the pyranone 2 at the required step in the API synthesis.
机译:None

著录项

  • 来源
    《Analytical methods》 |2017年第10期|共8页
  • 作者单位

    Bristol Myers Squibb Chem &

    Synthet Dev Reeds Lane Moreton CH46 1QW England;

    Bristol Myers Squibb Global Mfg &

    Supply 1 Squibb Dr New Brunswick NJ 08903 USA;

    Bristol Myers Squibb Chem &

    Synthet Dev Reeds Lane Moreton CH46 1QW England;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 分析化学;
  • 关键词

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