EsCitalopram N-Desmethyl (Free Base) é uma impureza processual frequentemente monitorada em matérias-primas de escitalopram. Caracteriza-se por perda de um grupo metil | afetando o perfil de pureza do API e potencialmente influenciando o desempenho analítico. A sua presença é detectada por HPLC com padrões de referenciação e confirmada por espectrometria de massas e RMN para identificação inequívoca. O controle exige validação de método | definição de limites de aceitabilidade no dossier de qualidade e estratégias de processo como otimização das etapas de N-metilação e purificação por cromatografia. Estudos de estabilidade e avaliação toxicológica sustentam especificações e gerenciamento de risco.
Referências
Landy, K., Rosani, A., & Estevez, R. (2022, October 9). Escitalopram. Retrieved November 4, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK557734/
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