Testes compendiais e orientação regulatória
Os patrocinadores e requerentes de medicamentos são obrigados a propor especificações (ou seja, atributos, procedimentos analíticos e critérios de aceitação) para os excipientes, insumos farmacêuticos ativos e medicamentos em seus pedidos. Estas especificações devem aderir aos padrões de qualidade dispostos na Farmacopeia/Formulário Nacional dos Estados Unidos (USP/NF), na Farmacopeia Britânica (BP), na Farmacopeia Europeia (EP) ou na Farmacopeia Japonesa (JP). Os testes farmacopeicos compendiais são protocolos padronizados para muitas matérias-primas e produtos finais farmacêuticos. Os testes e a conformidade com essas normas detalhadas nos métodos compendiais são requisitos básicos para a fabricação, liberação e distribuição de ingredientes farmacêuticos e medicamentos em nível global.
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Protocolos relacionados
- An MS-compatible alternative to the USP and EP methods, with improved specificity and reduced analysis time.
- Separation of Prednisolone, pharmaceutical secondary standard; traceable to USP, PhEur and BP
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Destaques
Do desenvolvimento à liberação do medicamento, este PDF interativo descreve diversos filtros e reagentes confiáveis e consistentes para o protocolo de teste de dissolução
Explorando as tendências e os principais desafios enfrentados pela comunidade envolvida na análise e CQ farmacêuticos, quatro pontos-chave surgiram a partir deste levantamento
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