5-Cloro bupropion fumarato (CAS 1193779-50-8) se presenta como impureza crítica en el desarrollo farmacéutico y requiere control analítico riguroso. Su perfil de impurezas debe caracterizarse mediante HPLC | LC-MS y RMN para confirmar identidad | cuantificar presencia y establecer límites de aceptación. Estudios de estabilidad forzada y degradación acelerada permiten definir rutas de formación y condiciones que favorecen su aparición. La cuantificación validada y reproducible es esencial para especificaciones | manejo de riesgos y cumplimiento regulatorio. Una documentación completa de métodos | validación y límites de identificación facilita la trazabilidad y el control de calidad durante fabricación y liberación.
Referencias
“Bupropion (Wellbutrin), NAMI: National Alliance on Mental Illness.†Nami.org, 2021, www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Bupropion-(Wellbutrin)#:~:text=Bupropionisanantidepressantmedication, feelingsademptyortearful.
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