(1:1 mixture of levetiracetam S-enantiomer-(2S)-2-(2-oxopyrrolidin-1-yl)butanamide and levetiracetam R-enantiomer (2R)-2-(2-oxopyrrolidin-1-yl)butanamide)
Sinônimos farmacopeicos
N/A
Outros sinônimos
N/A
Descrição
Impureza Levetiracetam Racemic Mixture (CAS 33996-58-6) representa um contaminante enantiomérico associado ao princípio ativo; sua presença altera o perfil de impurezas e pode impactar pureza | estabilidade e atividade farmacológica do lote. Caracteriza-se por pares enantioméricos e impurezas relacionadas estruturalmente | exigindo estratégias analíticas robustas como HPLC quiral | LC-MS/MS e RMN para identificação | quantificação e elucidação de vias de degradação. O controle consiste em limites especificados | validação de métodos e medidas de remoção em processos de síntese e purificação. Avaliações toxicológicas e de risco devem suportar especificações e garantir conformidade regulatória do produto final.
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