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Case Study: Unstable API Impurity

A recent client contracted with a company that was unsuccessful in isolating an API impurity due to instability of the impurity (see Isolation scenario 1). The client subsequently contracted with Novatia to do the same work. The impurity was sufficiently characterized by LCMS to confirm its likely identity and chemical nature. Conditions were then designed to minimize degradation during isolation following preparative chromatographic separation (Isolation Scenario 2). Complete and clean data sets were employed in documenting the impurity’s identity and spectral assignments.