1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-bupropion (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
El N-Nitroso bupropion (CAS: 2763780-10-3) es una impureza nitrosada relevante en el perfil de calidad del bupropion. Se caracteriza por su potencial genotóxico inherente a los compuestos N-nitroso | lo que exige monitorización rigurosa durante la síntesis | purificación y almacenamiento. Su detección y cuantificación se realiza típicamente mediante LC-MS/MS o GC-MS con límites de cuantificación bajos y requiere métodos validados y criterios de aceptación alineados con guías regulatorias. La gestión del riesgo incluye eliminación de precursores nitrosantes | control de pH | uso de agentes reductores y condiciones anóxicas para minimizar su formación | así como estudios de estabilidad bajo estrés.
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