Abacavir Dinitroso Impurity | también identificada como ABCRC-1 Dinitroso Impurity | es una impureza dinitrosada que puede formarse como subproducto durante la síntesis y degradación del principio activo. Su caracterización exige técnicas analíticas avanzadas como HPLC y LC MS para el perfil de impurezas | soporte por RMN | espectroscopía IR y análisis elemental. La presencia de esta impureza afecta la pureza química y requiere límites de especificación y procedimientos de eliminación o control en etapas de síntesis y purificación. Estudios de estabilidad y pruebas de proceso permiten identificar las condiciones catalizantes su formación y establecer estrategias de mitigación para cumplimiento regulatorio y garantía de calidad.
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