Informações adicionais sobre o Levetiracetam Alkene Impurity
Fármaco de origem
Levetiracetam
Nome IUPAC
(Z)-2-(2, 3-dioxopyrrolidin-1-yl)but-2-enamide
Sinônimos
N/A
Descrição
Impureza alqueno do levetiracetam é um subproduto insaturado formado por reações de eliminação durante a síntese ou por degradação térmica do API. Caracteriza-se pela presença de dupla ligação | massa molecular compatível com perda de hidrogênio e deslocamento no cromatograma | afetando o perfil de impurezas. Identificação e quantificação são feitas por HPLC acoplado a espectrometria de massas | GC-MS para voláteis e RMN para confirmação estrutural. Essa impureza pode comprometer pureza | estabilidade e perfil toxicológico do material e por isso deve ser alvo de controle de qualidade com limites e estratégias de mitigação na síntese e purificação.
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