Alogliptin Impurity 13 (CAS 865758-98-1) é uma impureza relacionada identificada no processo de síntese de alogliptina | com propriedades físico-químicas e massa molecular específicas que influenciam o perfil de pureza do produto. A sua detecção e quantificação são realizadas por HPLC com detecção UV e confirmação por espectrometria de massas | possibilitando elucidação estrutural e avaliação de traços. Estudos de estabilidade forçada indicam vias de formação por degradação e reações secundárias | requerendo critérios analíticos | especificações e estratégias de controle no desenvolvimento analítico. Informações sobre esta impureza são essenciais para avaliação de risco | validação de método e conformidade regulatória.
Referências
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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