Nilotinib EP Impurity D (CAS 641569-94-0) | también denominada Nilotinib Carboxylic Acid Impurity | es una impureza relacionada estructuralmente con Nilotinib que incorpora un grupo carboxílico | lo que modifica su solubilidad y perfil de ionización en soluciones analíticas. Su identificación y cuantificación son críticas en control de calidad y estudios de estabilidad debido al impacto en el perfil de impurezas del lote. La impureza responde bien a técnicas analíticas modernas como HPLC con detección UV y LC-MS para confirmación de masas | permitiendo establecer especificaciones | límites y procedimientos de liberación conforme a requisitos regulatorios.
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