Levetiracetam EP Impurity C entspricht Pyrrolidon, auch 2-Pyrrolidon, CAS 142-08-5, mit der Summenformel C5H5NO und einer Molekülmasse von 95,1 g/mol. Als Lactam-Heterozyklus ist es strukturell mit dem Racetam-Gerüst verwandt, besitzt jedoch nicht die Acetamid-Seitenkette von Levetiracetam, was auf eine Bildung als Synthesenebenprodukt oder aus Vorläuferumwandlungen hinweist. Die geringe UV-Aktivität und hohe Polarität erfordern für Identifizierung und Spurenbestimmung typischerweise LC-MS/MS; nach Derivatisierung ist auch GC-MS geeignet. Die regulatorische Bewertung erfolgt im Rahmen von Verunreinigungsprofilen und ICH-basierten Kontrollstrategien.
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