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Issue 10, 2017
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The use of glutathione as a derivatising agent for the analysis of Michael acceptor genotoxic impurities in pharmaceuticals

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Abstract

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.

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

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Publication details

The article was received on 17 Jan 2017, accepted on 17 Feb 2017 and first published on 20 Feb 2017


Article type: Paper
DOI: 10.1039/C7AY00158D
Anal. Methods, 2017,9, 1603-1610

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

    J. Chadwick, A. Kelly and E. Quirk, Anal. Methods, 2017, 9, 1603
    DOI: 10.1039/C7AY00158D

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