Impureza bromo da beclometasona é uma impureza halogenada observada em matérias primas e produtos acabados que pode resultar de reações de halogenação ou contaminação durante síntese e purificação. Caracteriza-se por alterações no perfil cromatográfico e massa molecular | exigindo identificação por HPLC com detecção UV | LC-MS e RMN para confirmação estrutural. A presença dessa impureza pode afetar potência | estabilidade e aceitabilidade regulatória do lote | por isso limites de aceitação devem ser estabelecidos em especificações e métodos analíticos validados. Estudos de degradação forense e controle em processo minimizam sua formação e garantem conformidade com boas práticas de fabricação.
Referências
Nandan, D., Singh, A., Dewan, V., & Sankar, J. (2016). Comparison of clinical effects of beclomethasone dipropionate & budesonide in treatment of children with mild persistent asthma: A double-blind, randomized, controlled study. Indian Journal of Medical Research, 144(2), 250. https://doi.org/10.4103/0971-5916.195040
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