Ibuprofen EP Impurity B, identified as p-Butyl Ibuprofen, is a positional isomeric arylpropionic acid impurity associated with the ibuprofen manufacturing route and may arise from incomplete alkylation or regioisomeric carryover during Friedel-Crafts acylation and subsequent side-chain transformations. CAS 3585-49-7 corresponds to molecular formula C13H18O2 and molecular weight 206.29 g/mol. As a non-genotoxic structural impurity rather than a reactive alerting moiety, its significance is principally pharmacopoeial and compositional. Trace-level determination typically requires reversed-phase HPLC with UV detection, confirmed by LC-MS or GC-MS when isomeric discrimination is necessary.
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