(S)-Methyl 2-(2-oxopyrrolidin-1-yl)butanoate (CAS 358629-51-3) | sinónimo (2S)-2-(2-oxopyrrolidin-1-yl)butanoic acid methyl ester | es una impureza quiral relevante en controles de calidad que incorpora una lactama de pirrolidinona y un éster metílico; su detección y cuantificación precisas son críticas para el perfil de impurezas. Se recomienda monitorizar mediante HPLC y LC-MS con métodos validados y separación en fase quiral para evaluar pureza enantiomérica | así como establecer límites y criterios de aceptación conformes a guías ICH. Su polaridad moderada y comportamiento frente a condiciones básicas condicionan estrategias de purificación y estabilidad analítica.
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