Bedaquiline Impurity 1 (mezcla de enantiómeros) corresponde al derivado 4-amino-1-(6-bromo-2-metoxiquinolin-3-il)-2-(naftalen-1-il)-1-fenilbutan-2-ol; se caracteriza por su centro estereogénico y comportamiento diastereomérico en fases de separación cromatográfica. Esta impureza exige evaluación detallada mediante HPLC quiral | LC-MS y RMN para definir su perfil | constantes de retención y fragmentación. Su presencia puede alterar el perfil de pureza y propiedades fisicoquímicas del principio activo | por lo tanto se requiere establecer límites especificados | desarrollar métodos de cuantificación validados y realizar estudios de estabilidad para controlar riesgos en el proceso de síntesis.
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