Impureza Diltiazem Sulfoxide (CAS 370094-12-5) é um produto de oxidação do tioéter presente em lotes de diltiazem | formado durante etapas sintéticas ou por degradação oxidativa em armazenamento. Do ponto de vista analítico | requer monitoramento por HPLC com detecção UV e confirmação por LC-MS e RMN para caracterização estrutural e quantificação precisa. Sua presença pode alterar perfil de pureza | estabilidade e segurança do API | exigindo estratégias de controle como otimização de condições de síntese | uso de agentes redutores | controle de oxigênio e estudos de degradação forçada. Especificações e limites devem ser definidos conforme ICH Q3A Q3B e validados por métodos analíticos robustos.
Referências
Chatpalliwar, Vivekanand A., et al. “Validated Gradient Stability Indicating HPLC Method for Determining Diltiazem Hydrochloride and Related Substances in Bulk Drug and Novel Tablet Formulation.” Journal of Pharmaceutical Analysis, vol. 2, no. 3, June 2012, pp. 226–37, https://doi.org/10.1016/j.jpha.2012.01.003.?Buckley, Micaela M. -T ., et al. “Diltiazem.” Drugs, vol. 39, no. 5, May 1990, pp. 757–806, https://doi.org/10.2165/00003495-199039050-00009.?
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