Alogliptin Impurity 23 (CAS 1618644-29-3) es una impureza identificada en el perfil de calidad de lotes de alogliptina | caracterizada mediante técnicas analíticas como HPLC y LC-MS y confirmada por espectroscopía NMR cuando procede. Su aparición se asocia a rutas de reacción secundarias y a condiciones de degradación térmica o por humedad durante síntesis y almacenamiento. La cuantificación precisa es crítica para el cumplimiento de especificaciones y límites regulatorios | por lo que se recomienda el desarrollo de métodos validados de separación | identificación y cuantificación | estudios de estrés y perfiles de impurezas relacionadas para establecer controles de proceso y criterios de aceptación basados en riesgo.
Referencias
Cada, Dennis J., et al. “Alogliptin.†Hospital Pharmacy, vol. 48, no. 7, 2013, pp. 580–592, www.ncbi.nlm.nih.gov/pmc/articles/PMC3839527/, 10.1310/hpj4807-580. Accessed 4 Nov. 2021.
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