Ibuprofen EP Impurity A, also designated m-Isobutyl Ibuprofen, is a positional isomeric related substance of ibuprofen with CAS 66622-47-7, molecular formula C13H18O2, and molecular weight 206.28 g/mol. Structurally, it retains the arylpropionic acid scaffold while relocating the isobutyl substituent, consistent with an isomerization or regioisomeric synthetic byproduct profile rather than a classical degradation product. In pharmacopeial impurity control, it is assessed as a defined related compound using reversed-phase HPLC with diode-array detection and, for unequivocal structural assignment or trace-level quantification, LC-MS/MS or GC-MS. Its presence supports impurity profiling and specification setting for ibuprofen drug substance and formulations.
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