A Alogliptin Impurity 23 (CAS 1618644-29-3) é uma impureza identificada no processo de síntese da alogliptina que requer monitorização rigorosa. Caracteriza-se por propriedades físico-químicas e espectrais específicas que permitem sua deteção e quantificação por HPLC com deteção UV e confirmação por espectrometria de massas e RMN. Estudos de estabilidade e perfil de degradação definem limites de especificação e critérios de aceitação baseados no risco toxicológico e requisitos regulamentares. Métodos analíticos validados | controlos de processo e estratégias de purificação são essenciais para minimizar a sua incidência em matéria-prima e intermediários | garantindo a qualidade do lote farmacêutico.
Referências
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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