La impureza Bupropion 3,4-Dichloro Impurity (CAS 1346598-72-8) es una impureza halogenada relacionada con el proceso del marco sintético de bupropión, probablemente originada por arrastre de precursores aromáticos clorados o por rutas de reacción secundaria durante la preparación de intermediarios. Con fórmula molecular C13H18Cl3NO y peso molecular de 310.65 g/mol, constituye un análogo estructural y no un simple producto de degradación. Su sustitución triclorada incrementa la hidrofobicidad cromatográfica y puede modificar la ionización, por lo que su caracterización exige habitualmente LC-MS/MS, LC-MS de alta resolución y, cuando procede la derivatización volátil, GC-MS. La evaluación regulatoria se enmarca en ICH Q3A/Q3B y criterios de cualificación toxicológica basados en umbrales.
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