Alogliptin Impurity 26 | CAS 865759-10-0 | é uma impureza relacionada identificada no desenvolvimento e produção de alogliptina que requer monitoramento rigoroso. Caracterizada como substância relacionada detectável por HPLC e LC-MS | esta impureza influencia o perfil de impurezas do lote e pode surgir por degradação ou reações secundárias durante síntese e armazenamento. A quantificação exige métodos validados e sensíveis | com limites definidos conforme diretrizes ICH para assegurar conformidade regulamentar. Estudos de estabilidade | elucidação estrutural por RMN e espectrometria de massas e estratégias de purificação dirigidas são essenciais para controlar níveis e avaliar impacto sobre qualidade do material farmacêutico.
Referências
Dineen, Laura, et al. “Alogliptin (Nesina) for Adults with Type-2 Diabetes.†Pharmacy and Therapeutics, vol. 39, no. 3, 1 Mar. 2014, pp. 186–202, www.ncbi.nlm.nih.gov/pmc/articles/PMC4005122/.
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