Información adicional sobre el Caffeine Impurity 1 (Na Salt)
Fármaco de origen
Caffeine
Nombre IUPAC
4-(1, 3-dimethylureido)-1-methyl-1H-imidazole-5-carboxylate, sodium salt (1:1)
Sinónimos
N/A
Descripción
La impureza de cafeína 1 en su forma salina sódica presenta características fisicoquímicas distintivas relevantes para control de calidad y desarrollo analítico. Su naturaleza iónica incrementa la solubilidad en fase acuosa y puede modificar el comportamiento cromatográfico | generando desplazamientos en tiempos de retención en HPLC y afectando la respuesta UV. Es detectable y cuantificable mediante HPLC acoplada a espectrometría de masas y confirmable por RMN | permitiendo evaluar degradación | perfiles de síntesis incompletos y trazas de subproductos. Se recomienda monitorear estabilidad frente a humedad y temperatura y aplicar criterios de identificación y límites de aceptación adecuados para cumplimiento regulatorio.
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