Metoprolol EP Impurity C, also designated Metoprolol Related Compound C and Bisoprolol EP Impurity L (free base), CAS 29122-74-5, is a defined structural impurity with molecular formula C13H19NO3 and molecular weight 237.29 g/mol. The compound is a beta-amino alcohol ether of the aryloxypropanolamine class, consistent with process-related formation through incomplete etherification, regioisomeric synthesis, or hydrolytic transformation of related beta-blockers. Its separation often requires reversed-phase LC coupled to UV and confirmation by LC-MS/MS, with NMR used for structural assignment and impurity profiling. Regulatory evaluation focuses on related-substance control rather than ICH M7 genotoxic concern.
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