As a drug candidate moves successfully through the development process it becomes increasingly important to identify drug related impurities.  Isolation of low-level (0.1-1.0%) drug product degradants for structure identification can prove very cumbersome and time consuming when going directly through the drug product as a sample source.  Sample enrichment becomes a critical step to support the structure elucidation process.  One can exploit the degradation chemistry “toolbox” by generating targeted screens with a narrow approach in experimental design.  Case studies will be presented to highlight sample enrichment and isolation process that ultimately support MS and NMR structure elucidation of targeted low level drug product degradants.<br/>

Applying investigative forced degradation strategies to better understand drug product formulation stability

252nd National Meeting (2016)

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