N-Desmethyl Clarithromycin; 1, 3-bis[3-[4-(5-Chloro-2, 3-dihydro-2-oxo-1H-benzimidazol-1-yl)-1-piperidinyl]propyl]-1, 3-dihydro-2H-benzimidazol-2-one; Domperidone Impurity F
Descrição
Clarithromycin EP Impurity D (CAS 101666-68-6) | também referida como N-Desmethyl Clarithromycin ou Domperidone Impurity F | é uma impureza relacionada identificada em matérias-primas de claritromicina. Caracteriza-se por desmetilação da porção macrocíclica | impactando o perfil de impurezas e a estabilidade do API. A sua detecção e quantificação exigem técnicas analíticas robustas como HPLC com detecção UV | LC-MS para confirmação de massa e RMN para elucidação estrutural. Monitorização sistemática segundo monografias EP e limites especificados reduzem riscos de lote fora de especificação e garantem conformidade regulatória. Constitui padrão de referência para desenvolvimento de métodos e investigação de vias de degradação.
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