Información adicional sobre el N-Nitroso Desmethyl Bedaquiline
FDA Potency Category 1 NDSRI
26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-bedaquiline (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitroso Desmethyl Bedaquiline es una impureza nitrosaminada derivada de la desmetilación y posterior nitrosación del precursor bedaquilina | relevante como preocupación de seguridad por su potencial genotóxico. Su caracterización analítica requiere métodos sensibles como LC-MS/MS y GC-MS con límites de detección en trazas | además de técnicas cromatográficas HPLC para separación y cuantificación. El perfil de formación se asocia a condiciones de síntesis | fuentes de nitrosantes y almacenamiento; por eso el control de proceso | criterios de aceptación en el lote y estudios de estabilidad son críticos. La identificación estructural | la purificación y la validación del método son esenciales para cumplimiento regulatorio.
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