La impureza 3-Nitroso-2 | 3 | 4 | 5-tetrahydro-1H-1 | 5-methanobenzo[d]azepine es un derivado nitroso de un anillo azepínico que puede formarse por nitrosación de aminas secundarias durante la síntesis o por exposición a agentes nitrosantes en condiciones de almacenamiento. Presenta propiedades fisicoquímicas que incluyen polaridad moderada y reactividad redox | y muestra sensibilidad a la reducción y a la luz. Su identificación y cuantificación se realiza preferentemente mediante HPLC con detección UV y confirmación por LC-MS y RMN | empleando métodos analíticos validados. El control se basa en evitar agentes nitrosantes | optimizar condiciones de pH y purificación por cromatografía y fijar límites de aceptación en especificaciones de impurezas.
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