Leflunomide EP Impurity D, CAS 42831-50-5는 분자식 C5H5NO3, 분자량 127.10 g/mol의 5-메틸이소옥사졸-4-카복실산에 해당하는 저분자 대사체이다. 이는 헤테로방향족 카복실산으로서 레플루노마이드의 합성 및 대사적 분해와 연관되며, 아닐리드 결합된 pharmacophore의 절단을 반영한다. 규제학적 관점에서 이는 니트로사민과 같은 구조적 경고군이 아니라 불순물 프로파일링과 공정 이해에 중요하다. 정량에는 일반적으로 LC-MS/MS 또는 고분해능 UHPLC-MS가 요구되며, 이성질체와의 구별을 위해 NMR 및 질량분석 기반 fragmentation 해석이 사용된다.
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