Valsartan EP Impurity C, also designated Valsartan Related Compound B or Valsartan N-Butyryl Analog, is a structurally defined synthetic process impurity of the angiotensin II receptor antagonist valsartan. CAS 952652-79-8; molecular formula C23H27N5O3; molecular weight 421.49 g/mol. The impurity differs from the parent drug by N-acyl homologation of the valine-derived amino functionality, consistent with side product formation during acylation or amidation steps in API synthesis. It is not a nitrosamine, but its presence is assessed within impurity profiling and related-substance control strategies. Quantification commonly relies on stability-indicating LC-MS/MS and LC-UV, with LC-HRMS for structural confirmation.
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