Procaine Impurity B, formula C13H20N2O3 and molecular weight 252.31 g/mol, is a structurally related aromatic amino ester impurity associated with procaine chemistry rather than a classical nitrosamine or genotoxic alert compound. It is typically considered a process-related or degradation-derived species arising from incomplete esterification, transesterification, or hydrolytic redistribution of the p-aminobenzoate and diethylaminoethanol fragments. Owing to its close polarity and ionization behavior, trace determination generally requires LC-MS/MS with selected reaction monitoring, often supported by high-resolution MS and chromatographic separation under acidic conditions to resolve it from the parent anesthetic and related esters.
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