Nilotinib Impurity 28 (CAS 1807607-72-2) es una impureza relacionada estructuralmente con el principio activo que requiere control riguroso durante el desarrollo y la fabricación. Su identificación y cuantificación son críticas para la seguridad y cumplimiento regulatorio | se recomienda el uso de HPLC acoplado a detección por UV y confirmación mediante LC-MS y RMN para caracterización estructural y determinación de punto de ruptura. Estudios de estabilidad y degradación acelerada permiten definir su origen y justificar límites en la especificación del material. Estrategias de control incluyen perfiles de impurezas | procedimientos de purificación dirigidos y métodos analíticos validados para asegurar consistencia en lotes y conformidad con normas de calidad.
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