N-Nitroso Aceclofenac is the N-nitrosamine derivative of aceclofenac, a structurally defined impurity of toxicological concern arising from nitrosation of the anilide nitrogen under acidic, nitrite-containing, or process-related conditions. With molecular formula C16H12Cl2N2O5 and molecular weight 383.18 g/mol, it contains the canonical N-nitroso motif associated with potential genotoxicity and assessment under ICH M7 and related nitrosamine risk frameworks. Trace-level determination typically requires selective LC-MS/MS or high-resolution LC-MS, with confirmatory GC-MS when volatility and chromatographic behavior permit, because conventional UV methods lack sufficient specificity for this class of impurity.
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