Información adicional sobre el Rifamycin Impurity- 3(INHM)
Fármaco de origen
Rifampicin
Nombre IUPAC
Rifamycin Impurity- 3(INHM)
Sinónimos
N/A
Descripción
Rifamycin Impurity-3 (INHM) es una impureza derivada de la degradación de compuestos rifamicínicos que requiere evaluación analítica rigurosa. Presenta propiedades fisicoquímicas que dificultan su separación por HPLC sin métodos de gradiente y suele detectarse por LC-MS y resonancia magnética nuclear para confirmación estructural. Su presencia afecta el perfil de impurezas | la estabilidad y la pureza del ingrediente farmacéutico | por lo que se establecen límites de especificación y estrategias de control mediante métodos indicativos de estabilidad. La cuantificación reproducible y los estándares de referencia son esenciales para la gestión de riesgo | investigación de vías de formación y cumplimiento regulatorio.
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