Informações adicionais sobre o Met(O) 8-Teriparatide
Fármaco de origem
Teriparatide
Nome IUPAC
Met(O) 8-Teriparatide
Sinônimos
N/A
Descrição
Met(O) 8-Teriparatide é uma impureza oxidada do peptídeo teriparatida resultante da oxidação do resíduo de metionina na posição 8 | caracterizada por aumento de massa de 16 Da e alteração da hidrofobicidade. Esta variante impacta estabilidade | atividade biológica e perfil de segurança | por isso sua quantificação é crítica em controle de qualidade. Métodos analíticos de alta resolução como HPLC reverso acoplada à espectrometria de massa | peptide mapping por LC-MS/MS e ensaios de degradação forçada permitem detecção sensível e caracterização estrutural. Definir limites de especificação e monitorar formação durante desenvolvimento e armazenagem minimiza riscos clínicos e regulatorios.
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