Osimertinib Impurity 2 DiHCl es una impureza relacionada que emerge durante la síntesis y proceso de purificación de osimertinib. Presenta implicaciones en estabilidad y perfil de impurezas | por lo que su identificación y cuantificación son críticas para el control de calidad. Su caracterización se logra mediante técnicas analíticas como HPLC con detección UV | LC-MS para determinación de masa y NMR para confirmación estructural. Estudios de degradación forzada ayudan a definir su vía de formación y condiciones que favorecen su generación. El establecimiento de límites especificados | métodos validados y estrategias de mitigación en el proceso aseguran cumplimiento regulatorio y minimizan riesgos en el producto final.
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