A impureza dímero de dapagliflozina é um subproduto oligomérico identificado durante a síntese e na avaliação de estabilidade do princípio ativo | apresentando massa molecular aproximada do dobro do monómero e padrão de fragmentação específico em LC-MS; sua presença altera o perfil de pureza e exige monitorização por HPLC com parâmetros de retenção e limites de quantificação validados. A formação do dímero costuma decorrer de acoplamentos entre monómeros ou de condições inadequadas de processo e armazenamento | demandando investigação da via sintética | estudos de degradantes e definição de especificações | critérios de aceitação e estratégias de controle para atender requisitos regulatórios e garantir a qualidade.
Referências
Anderson, S. L. (2014). Dapagliflozin efficacy and safety: a perspective review. Therapeutic Advances in Drug Safety, 5(6), 242–254. https://doi.org/10.1177/2042098614551938 ‌
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