1-((1R | 5S)-8-amino-6-nitro-1 | 2 | 4 | 5-tetrahidro-3H-1 | 5-metanobenzo[d]azepin-3-yl)-2 | 2 | 2-trifluoroetan-1-ona es una impureza relacionada con el proceso que contiene un núcleo azepínico parcialmente saturado | un grupo nitro y una unidad trifluoroacetilo | rasgos que condicionan su polaridad y comportamiento analítico. Su presencia puede afectar la calidad del principio activo por variaciones en potencia y seguridad | por lo que su detección a niveles trazas es crítica. Se identifica y cuantifica por HPLC con detección UV y LC-MS | y su estructura se confirma mediante RMN. Se recomienda implementar una estrategia de control conforme a ICH | con métodos validados | perfiles de degradación y estudios de estabilidad y aislamiento para evaluación toxicológica.
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![1-((1R,5S)-8-amino-6-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one](https://veeprho.com/wp-content/uploads/2022/11/1-1R-5S-8-amino-6-nitro-1-2-4-5-tetrahydro-3H-1-5-methanobenzo-d-azepin-3-yl-2-2-2-trifluoroethan-1-one-sqr.png "1-((1R,5S)-8-amino-6-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one")
![1-((1R,5S)-6-amino-8-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one](https://veeprho.com/wp-content/uploads/2022/11/1-1R-5S-6-amino-8-nitro-1-2-4-5-tetrahydro-3H-1-5-methanobenzo-d-azepin-3-yl-2-2-2-trifluoroethan-1-one.png "1-((1R,5S)-6-amino-8-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one")
![3-benzyl-2,3,4,5-tetrahydro-1H-1,5-methanobenzo[d]azepine](https://veeprho.com/wp-content/uploads/2022/11/3-benzyl-2-3-4-5-tetrahydro-1H-1-5-methanobenzo-d-azepine.png "3-benzyl-2,3,4,5-tetrahydro-1H-1,5-methanobenzo[d]azepine")
