Impuritud relacionada con Alogliptin | designada Impuridad 15 (CAS 1108731-49-2) | identificada como subproducto del proceso sintético y caracterizada mediante LC-MS y RMN para determinación de estructura y masa exacta. Presenta comportamiento cromatográfico distintivo y solubilidad que influyen en la purificación y estabilidad del principio activo. Es clave en estudios de perfil de impurezas y en la validación analítica por HPLC con detectores UV y MS. Su control mediante optimización de proceso y límites de especificación acordes a ICH Q3A es esencial para asegurar calidad | seguridad y cumplimiento regulatorio del lote farmacéutico.
Referencias
Dineen, Laura, et al. “Alogliptin (Nesina) for Adults with Type-2 Diabetes.†Pharmacy and Therapeutics, vol. 39, no. 3, 1 Mar. 2014, pp. 186–202, www.ncbi.nlm.nih.gov/pmc/articles/PMC4005122/.
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