A Impureza EP A do levetiracetam, também designada racemato do ácido carboxílico de levetiracetam, é o ácido carboxílico de cadeia aberta em configuração racémica derivado do fármaco de núcleo pirrolidónico. CAS 67118-31-4, fórmula molecular C8H13NO3 e massa molecular 171.19 g/mol. Trata-se de um produto de hidrólise ou de síntese associado à abertura do anel 2-oxopirrolidínico, não pertencendo a uma classe genotóxica reativa. Pela sua polaridade e proximidade estrutural com a substância ativa, a determinação geralmente requer HPLC em fase reversa com deteção UV ou confirmação por LC-MS/MS, sendo LC-HRMS usado como abordagem ortogonal em perfis de impurezas traço.
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