N-Nitroso Osimertinib 3-Hydroxy Impurity is a nitrosamine-derived degradation product characterized by nitrosation of the Osimertinib scaffold with a 3-hydroxy substitution, posing analytical and control challenges in drug substance development. This polar impurity is typically monitored by LC-HRMS and LC-MS/MS for accurate mass and fragmentation patterns, with orthogonal confirmation by 1H and 13C NMR and HPLC-UV retention profiling. Formation pathways include nitrosation under acidic or oxidative conditions and hydroxylation during synthesis or storage. Effective control strategies include optimization of synthetic routes, elimination of nitrosating reagents, validated purification and desalting steps, and stability testing with established limits.
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