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In Silico Strategies to Assess Potentially Mutagenic Impurities Under ICH M7

pdf fileLepley L; Barber CG;

The ability to assess an impurity as either non-mutagenic or not present in the final API can offer significant efficiencies without compromising safety. In silico tools can provide a robust and cost-efficient solution, provided they are fit-for-purpose.

These are the slides and supporting workbook from the Lhasa Limited 2017 SOT vendor session in which an integrated solution to ICH M7 was reviewed. The case study was based on the synthetic scheme of Pimavanserin and included database/literature searching, in silico prediction using an expert rule-based and statistical-based system and consideration of the purging of intermediates.

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