2-hydroxy-7 | 8 | 9 | 10-tetrahydro-6 | 10-methano-6H-pyrazino[2 | 3-h][3]benzazepine es una impureza heterocíclica que puede formarse durante la síntesis o como producto de degradación; su perfil químico incluye un grupo hidroxilo y un sistema fused de azepina y pirazina que condicionan su polaridad y reactividad. Para control analítico se recomienda la caracterización por HPLC reversa con detección UV y confirmación por LC-MS y RMN 1H/13C | aprovechando patrones de fragmentación y desplazamientos químicos distintivos. La presencia de esta impureza puede influir en la pureza del lote y en los estudios de estabilidad | por lo que se establecen límites de aceptación y métodos validados de cuantificación y ensayo de degradación forzada.
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