Impureza 4-Propylpyrrolidin-2-one (CAS 89895-19-2) aparece como un subproducto lipofílico en síntesis de lactamas | presente a niveles traza que afectan el perfil de impurezas y la estabilidad del lote. Tiene propiedades fisicoquímicas: moderada polaridad | punto de ebullición intermedio y solubilidad en disolventes orgánicos | lo que complica su remoción por extracción simple. Su identificación y cuantificación requieren métodos analíticos específicos como HPLC con detección UV o MS | GC-MS para fracciones volátiles y RMN para confirmación estructural. El control estricto de impurezas | límites de aceptación y estudios de degradación son críticos para evaluar su impacto en la calidad y seguridad del producto final.
Referencias
Feyissa, A. M. (2019). Brivaracetam in the treatment of epilepsy: a review of clinical trial data. Neuropsychiatric Disease and Treatment, Volume 15, 2587–2600. https://doi.org/10.2147/ndt.s143548
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