Levetiracetam EP Impurity C corresponde à pirrolidona, 2-pirrolidona, CAS 142-08-5, fórmula molecular C5H5NO e massa molar de 95,1 g/mol. Como heterociclo lactâmico, é estruturalmente relacionado ao arcabouço racetam, porém sem a cadeia acetamida do levetiracetam, sugerindo origem como subproduto de síntese ou de transformações de precursores, em vez de degradante oxidativo clássico. Sua baixa cromoforicidade e elevada polaridade normalmente exigem LC-MS/MS para identificação inequívoca e quantificação em nível traço, com GC-MS também aplicável após derivatização. A avaliação regulatória concentra-se no perfil de impurezas de प्रक्रिया e em estudos de destino de impurezas sob estruturas compendiais e orientações ICH.
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