Informações adicionais sobre o Acetylcysteine Impurity 4 (Disodium Salt)
Fármaco de origem
Cysteine
Nome IUPAC
Acetyl(sulfinato)-D-alaninate, sodium salt (1:2)
Sinônimos
N/A
Descrição
Acetylcysteine Impurity 4 (Disodium Salt) é uma impureza identificada em processos de síntese de acetilcisteína | caracterizada como sal dissódico com propriedades físico-químicas específicas que impactam o perfil de pureza do ativo. Fornece referências analíticas essenciais para desenvolvimento de métodos de controle de qualidade incluindo HPLC | espectrometria de massas e RMN para confirmação estrutural. Sua solubilidade aquosa | comportamento de retenção cromatográfica e tendência a formar sais influenciam limites de especificação e estudos de estabilidade. Informação robusta sobre este composto suporta estabelecimento de critérios de aceitação | validação de métodos e investigação de vias de degradação | atendendo requisitos regulatórios e boas práticas analíticas.
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