During the multi-stage process of developing active ingredients (AIs) toward a successful commercial launch, a critical activity in enabling product registration is the identification and structural assignment of all significant metabolites and impurities.  Additionally, commercialized actives also require similar support post registration.  As the structural complexity of AIs has increased over the years,  synthesis of the corresponding metabolites and process impurities is  equally challenging.  This presentation will discuss implementing novel approaches designed to overcome key  challenges such as regioselectivity, chemo selectivity, and robustness of  novel routes toward preparation of these  targets.

Expediting novel total synthetic routes to support AI registration

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ACS Spring 2023

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