Impureza Amlodipine Deschloro (CAS 88150-52-1) é um degradante estrutural relevante identificado durante síntese e armazenamento de amlodipino. Presença desta impureza pode afetar pureza do ativo e comprometer conformidade com especificações farmacopépticas. Características analíticas incluem massa molecular reduzida relativo ao composto parent | espectros de RMN e LC-MS compatíveis com perda de átomo de cloro. Métodos de detecção sensíveis como HPLC-UV e LC-MS/MS são recomendados para quantificação sub-ppm e estudos de perfil de impurezas. Estratégias de controle abrangem otimização de etapas sintéticas | monitoramento de impurezas relacionadas e validação de limites de aceitação para garantir segurança e eficácia.
Referências
Bulsara, Kishen G., and Manouchkathe Cassagnol. Amlodipine.” Nih.gov, StatPearls Publishing, 13 Oct. 2019, www.ncbi.nlm.nih.gov/books/NBK519508/. Fares, Hassan, et al. Amlodipine in Hypertension: A First-Line Agent with Efficacy for Improving Blood Pressure and Patient Outcomes.” Open Heart, vol. 3, no. 2, Sept. 2016, p. e000473, https://doi.org/10.1136/openhrt-2016-000473.
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