Maribavir Impurity 11 (CAS 176161-56-1) is a process- and degradation-related impurity detected in maribavir batches and stability samples, characterized by LC-MS and confirmed by NMR and high resolution mass spectrometry for structural elucidation. It typically coelutes near late-eluting polar degradants in reversed-phase HPLC, requiring tailored chromatographic conditions for robust separation and quantification. Impurity formation is linked to a specific synthetic step and to accelerated storage conditions, making it relevant for control strategy development. Identification, quantitation and qualification per ICH Q3A/Q3B are recommended, with defined acceptance criteria, reference standard preparation and risk assessment for potential toxicological concern.
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