A impureza Ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate (CAS 358629-53-5) é caracterizada como um contaminante de síntese detectável por HPLC e LC-MS com sinais reproducíveis em cromatogramas e espectros de massa | presença confirmada por 1H NMR e análise de pureza. Apresenta solubilidade preferencial em solventes orgânicos e sensibilidade a condições de reação prolongadas que favorecem formação por transesterificação ou racemização parcial. Para controle de qualidade recomenda-se monitoramento em rotina por HPLC com padrão interno | investigação de perfil de impurezas | ajuste de tempo e pH do processo e estratégias de purificação para redução a níveis traço.
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