Levetiracetam EP-Impurity A, auch als Levetiracetam-Carbonsäure-Racemat bezeichnet, ist die racemische, offenkettige Carbonsäure des pyrrolidonhaltigen Wirkstoffs. CAS 67118-31-4, Summenformel C8H13NO3, Molekulargewicht 171,19 g/mol. Die Verbindung entsteht typischerweise als hydrolytischer oder synthetischer Abbauprodukt nach Ringöffnung des 2-Oxopyrrolidin-Gerüsts und gehört nicht zu einer reaktiven genotoxischen Stoffklasse. Aufgrund ihrer hohen Polarität und engen strukturellen Verwandtschaft zum Wirkstoff erfolgt die Bestimmung meist mittels RP-HPLC mit UV-Detektion oder LC-MS/MS; für Spurenprofile in monographischen und Stabilitätsuntersuchungen sind ergänzend LC-HRMS-Verfahren üblich.
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