Informações adicionais sobre o N-Pivaloyl Amoxicillin Sodium Salt
Fármaco de origem
Amoxicillin
Nome IUPAC
(2S, 5R, 6R)-6-((R)-2-(4-hydroxyphenyl)-2-pivalamidoacetamido)-3, 3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate, sodium salt (1:1)
Sinônimos
N/A
Descrição
A impureza N-Pivaloyl Amoxicillin Sodium Salt representa um derivado N-acilado frequentemente monitorado no controle de qualidade de amoxicilina. Sua presença pode alterar o perfil físico-químico e exigir investigação de origem e vias de formação durante síntese | armazenamento e processamento. A detecção e quantificação por HPLC com detecção UV e confirmação por espectrometria de massas ou NMR são recomendadas para estabelecer limites de especificação e perfil de degradantes. Estudos de estabilidade | validação analítica e avaliação toxicológica suportam a definição de critérios de aceitabilidade em conformidade com requisitos regulatórios. Documentação robusta e procedimentos analíticos validados são essenciais para gerenciamento de risco e garantia de pureza do lote.
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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
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