Levetiracetam EP Impurity B, CAS 358629-47-7은 피롤리돈 기반 항경련제인 레베티라세탐과 연관된 공정 유래 또는 분해 유래 불순물이다. 분자식 C8H12N2O2, 분자량 168.19 g/mol의 중성 극성 헤테로고리 화합물로서 역상 LC 분리에 적합하지만, 구조적으로 유사한 유도체와의 구분을 위해 질량분석 기반의 정합이 요구되는 경우가 많다. 약전 및 불순물 프로파일 평가에서는 LC-MS/MS, 고해상도 LC-MS, 필요 시 NMR이 주로 사용된다. 규제 관점에서는 합성 경로에서의 생성 여부, 저장 중 축적 가능성, 그리고 불순물 규명과 정량의 적합성이 핵심이다.
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