ABSTRACT

Because drug products may undergo physicochemical degradation during manufacturing and storage, it is imperative that the inherent stability characteristics of a product be evaluated to ensure that safety is not compromised by the presence of toxic impurities [1, 2]. In particular, the isolation and structure elucidation of degradation products becomes critical in regulatory documents where the assessment of safety must be established. Potential toxic or mutagenic degradation products often need to be identified and unambiguously characterized.