Diclofenac EP Impurity B, also designated Diclofenac Related Compound B or Diclofenac Benzaldehyde Analog, is the aldehydic precursor o-(2,6-dichloroanilino)benzaldehyde, CAS 22121-58-0, with formula C13H9Cl2NO and molecular weight 266.12 g/mol. This aromatic amino benzaldehyde represents a synthetic intermediate and potential process-related impurity in diclofenac manufacture, arising from incomplete conversion or side-chain oxidation before formation of the phenylacetic acid motif. Its carbonyl function and dichloroanilino substituent make it chemically distinct from the active drug. Trace-level determination typically relies on LC-MS/MS, LC-UV with impurity-specific separation, and, where needed, GC-MS after derivatization.
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