Enzalutamide Impurity 11 (2-Fluoro-4-bromobenzoic acid, CAS 112704-79-7) is a process-related aromatic carboxylic impurity encountered during enzalutamide synthesis. It exhibits characteristic chromatographic retention and UV absorbance, necessitating targeted analytical characterization for precise quantitation within the impurity profile. Structural confirmation is performed by LC-MS, NMR and high-resolution mass spectrometry to differentiate halogenated benzoic by-products. Control measures focus on optimized reaction parameters, controlled bromination and selective workup to reduce formation, complemented by validated HPLC methods for routine QC and stability studies. Monitoring this impurity informs regulatory compliance and impurity risk assessment for drug substance quality.
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