A Alogliptina Impurity 22 (CAS 655-63-0) é uma impureza relacionada caracterizada por perfil cromatográfico e massa molecular distinta | relevante para o controle de qualidade de lotes farmacêuticos. Suas propriedades físico-químicas e comportamento durante estudos de estabilidade exigem quantificação por métodos como HPLC com detector UV e confirmação por LC-MS e RMN para identificação estrutural. Especificações analíticas contemplam limites de aceitação | procedimento de amostragem e validação conforme ICH Q3A e boas práticas analíticas. Fornecemos dados de retenção | espectros de massa e informações sobre condições de análise que auxiliam na avaliação de risco e na definição de estratégias de controle de impurezas.
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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