Amoxicillin EP Impurity D (CAS 1642629-94-4) | também conhecida como Amoxicillin Related Compound D ou Amoxicillin Penicilloic Acid | é um produto de degradação do anel beta-lactâmico formado por hidrólise e abertura do anel. Esta impureza é crítica para controle de qualidade e avaliação de estabilidade | exigindo quantificação por métodos validados como HPLC com detecção UV e espectrometria de massas para confirmação estrutural. A presença impacta aceitabilidade do lote e especificações farmacopéias | sendo utilizada como padrão de referência em ensaios de pureza e estudos de degradação forçada. Monitoramento sistemático e limites de aceitação são essenciais para conformidade com monografias.
Referências
Bucher, Heiner C. “Effect of Amoxicillin-Clavulanate in Clinically Diagnosed Acute Rhinosinusitis.†Archives of Internal Medicine, vol. 163, no. 15, 11 Aug. 2003, p. 1793, 10.1001/archinte.163.15.1793. Accessed 31 Oct. 2019.
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