Oxybuprocaine Hydrochloride EP Impurity C (CAS 2374-03-0), chemically 3-hydroxy-4-aminobenzoic acid or 3-Hydroxy-PABA, is a polar aromatic degradation product and synthetic by-product that requires targeted control in pharmaceutical quality systems. Its ionizable carboxyl and amino groups produce distinct chromatographic behavior, typically eluting early in reversed-phase HPLC and showing a characteristic [M-H] ion by LC-MS. Reliable identification and quantification rely on orthogonal techniques such as LC-MS, proton NMR and IR spectroscopy combined with validated sample preparation to address matrix effects. Monitoring this impurity is essential for EP compliance, impurity profiling, stability assessment and analytical method validation.
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