Alogliptin Impurity 13 (CAS 865758-98-1) es una impureza relacionada que requiere seguimiento en el perfil de calidad de lotes de alogliptina. Químicamente definida y cuantificable | su identificación se realiza por HPLC con detectores UV y confirmación por LC-MS y RMN para determinar la estructura y las posibles vías de degradación. La impureza debe evaluarse en estudios de estabilidad y mediante métodos analíticos validados para establecer límites conforme a requisitos regulatorios. Su control es esencial para garantizar la consistencia del proceso sintético | minimizar riesgos de seguridad y cumplir especificaciones de impurezas orgánicas en materia prima farmacéutica.
Referencias
Kaku, Kohei, et al. “Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus.†Drug Safety, vol. 42, no. 11, 25 Oct. 2019, pp. 1311–1327, 10.1007/s40264-019-00857-8. Accessed 1 May 2020.
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