Levetiracetam EP Impurity B, CAS 358629-47-7, corresponde a um componente definido, de origem processual ou de degradação, associado ao anticonvulsivante de núcleo pirrolidônico levetiracetam. Com fórmula molecular C8H12N2O2 e massa molecular de 168,19 g/mol, trata-se de um heterociclo neutro e polar, cujo comportamento fisicoquímico favorece a separação por LC em fase reversa, embora a semelhança estrutural com análogos próximos normalmente exija confirmação ortogonal por espectrometria de massas. Em contextos farmacopeicos e de perfil de impurezas, sua atribuição depende de LC-MS/MS, LC-MS de alta resolução e, quando necessário, confirmação por RMN. A avaliação regulatória concentra-se na origem sintética ou em armazenamento e na qualificação da impureza.
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