La impureza de apixaban 28 (CAS 2208275-54-9) corresponde a 6-(4-(3-hidroxi-2-oxopiperidin-1-yl)fenil)-1-(4-metoxifenil)-7-oxo-4 | 5 | 6 | 7-tetrahidro-1H-pirazolo[3 | 4-c]piridina-3-carboxamida. Se describe como un derivado oxidado o hidroxilado que puede originarse durante etapas de síntesis o por degradación del principio activo. Su perfil fisicoquímico requiere análisis por HPLC acoplado a espectrometría de masas y resonancia magnética nuclear para identificación inequívoca | y el desarrollo de métodos validados para cuantificación en límites trazables. La presencia de esta impureza afecta el perfil de seguridad y requisitos regulatorios | justificando estudios de estabilidad forzados y estrategias de eliminación en procesos de purificación.
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