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  • Theoretical purge factor determination as a control strategy for potential mutagenic impurities in the synthesis of drug substances
    Kragelj Lapanja, Nevenka ...
    Mutagenic impurities (MIs) are of serious concern for pharmaceutical industry, regulatory agencies and public health. The first guideline addressing the control of genotoxic impurities (GTIs) dates ... back to 2006. Since then there have been several updates and refinements, which eventually resulted in the guideline, published by the International Conference on Harmonisation (ICH) in June 2014. The ICH M7 guideline, compared to previous ones, offers greater flexibility in terms of control strategies for GTIs in drug substances. More specifically, it describes a control strategy that relies on process controls in lieu of analytical testing which is based on understanding the process chemistry and process parameters that impact the levels of GTIs. This principle is adopted in the theoretical purge factor determination tool proposed by Teasdale et al. Several case studies applying the proposed theoretical purge factor determination tool were published in recent years. The results confirm the tool%s good predictability of the extent to which the impurity is removed by the process. Hopefully, this approach will soon be released as an in-silico tool, generally accepted by the regulatory agencies.
    Vir: Acta chimica slovenica. - ISSN 1318-0207 (Vol. 64, no. 1, 2017, str. 1-14)
    Vrsta gradiva - članek, sestavni del
    Leto - 2017
    Jezik - angleški
    COBISS.SI-ID - 4393841

    Povezava(-e):

    https://journals.matheo.si/index.php/ACSi/article/view/2840
    Digitalna knjižnica Slovenije - dLib.si
    DOI

vir: Acta chimica slovenica. - ISSN 1318-0207 (Vol. 64, no. 1, 2017, str. 1-14)
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