Información adicional sobre el 5-Nitro-1-Nitroso-1H-imidazole
Fármaco de origen
Imidazole
Nombre IUPAC
5-Nitro-1-nitroso-1H-imidazole
Sinónimos farmacopeicos
N/A
Otros sinónimos
N/A
Smile
O=NN1C([N+]([O-])=O)=CN=C1
InChI
InChI=1S/C3H2N4O3/c8-5-6-2-4-1-3(6)7(9)10/h1-2H
Descripción
5-Nitro-1-Nitroso-1H-Imidazole es una impureza asociada a reacciones de nitración y nitrosación en síntesis de derivados de imidazol. Su presencia | marcada por los grupos nitro y nitroso | altera polaridad y espectroscopía UV y puede interferir en dosificación y pureza del API. El control analítico robusto mediante HPLC y LC-MS es esencial para su identificación | cuantificación y separación de isómeros. Desde el punto de vista de estabilidad esta impureza puede formarse por degradación oxidativa y requiere almacenamiento en ambiente inerte y protección frente a la luz y calor. Los límites deben establecerse según guías ICH y requerir evaluación toxicológica y calificación si procede.
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