Información adicional sobre el Norepinephrine Impurity 31 (Na Salt)
Fármaco de origen
Norepinephrine
Nombre IUPAC
3-hydroxy-1-methyl-6-oxido-5-oxo-2, 3, 4, 5-tetrahydro-3aH-indol-1-ium-3a-sulfonate, sodium salt (1:1)
Sinónimos
N/A
Descripción
Norepinephrine Impurity 31 (Na Salt) es una impureza observada en el perfil de degradación de norepinefrina en su forma de sal sódica. Presenta características fisicoquímicas definidas que influyen en su solubilidad | pKa y comportamiento cromatográfico; su identificación y caracterización se realizan mediante técnicas HPLC con detección UV y confirmación por espectrometría de masas de alta resolución | que aportan información sobre su masa exacta y fragmentación. La evaluación de su formación en condiciones de estrés | estabilidad y procesos de síntesis es crítica para establecer límites de aceptación basados en evaluación toxicológica y gestión de riesgo. Su control es parte integral del aseguramiento de calidad y del perfil de impurezas.
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