La impureza de Linagliptina 43 (CAS 1807608-59-8) es un degradado estructural identificado durante síntesis y estudios de estabilidad | caracterizada por sustituciones específicas en el núcleo xantina. Detectable por HPLC con detección UV y confirmable por LC-MS y RMN | muestra una masa molecular consistente con la fórmula propuesta y patrones de fragmentación distintivos. Su perfil analítico y niveles de aparición requieren control conforme a ICH Q3A y Q3B | debido a potenciales riesgos de seguridad y eficacia. Se recomienda implementación de límites especificados | métodos validados de cuantificación y estrategias de proceso para minimizar su formación y garantizar la calidad del producto final.
Referencias
«Freeman, M. K. (2011). Efficacy and safety of linagliptin (tradjenta) in adults with type-2 diabetes mellitus. P & T : A Peer-Reviewed Journal for Formulary Management, 36(12), 807–842. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278179/ «
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