Clarithromycin EP Impurity E, também designada Clarithromycin Related Compound A, é uma impureza macrolídica estruturalmente definida, associada ao arcabouço lactônico de 14 membros derivado da eritromicina da claritromicina. O CAS 81103-14-2 corresponde à fórmula molecular C39H71NO13 e ao peso molecular de 761.98 g/mol. Essa espécie é geralmente considerada uma substância relacionada de processo ou de degradação, originada por biotransformação parcial, migração acílica ou rearranjo do macrociclo contendo desosamina. A determinação em nível traço normalmente exige LC-MS/MS em fase reversa, espectrometria de massas de alta resolução e HPLC com detecção por arranjo de diodos. A avaliação regulatória centra-se na atribuição estrutural, fator de resposta relativo e especificação conforme monografias farmacopeicas.
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