Informações adicionais sobre o (S)-Pramipexole N-Methylene Dimer
Fármaco de origem
Pramipexole
Nome IUPAC
(S)-Pramipexole N-Methylene Dimer
Sinônimos
N/A
Descrição
Impureza (S)-Pramipexole N-Methylene Dimer é um subproduto de dimerização por ligação metileno ao nitrogênio observado durante a síntese de (S)-pramipexol. Esta impureza apresenta massa molecular e espectros que permitem identificação por LC-MS e confirmação estrutural por RMN 1H e 13C. Em controle de qualidade torna-se crítica a monitorização por HPLC com método validado para separação de dímeros e monômeros | definição de limites aceitáveis e investigação de perfil de impurezas em lotes. Estratégias de mitigação incluem otimização de etapas de proteção e desproteção | controle de condições reacionais | purificação cromatográfica e testes de estabilidade para prevenir formação e garantir conformidade regulatória.
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