Edoxaban Acid Impurity는 Edoxaban M1 Impurity 또는 Edoxaban Oxoacetic Acid Impurity로도 불리며, factor Xa 억제제 골격에서 유래한 정의된 분해 불순물로 CAS 767625-11-6에 등재되어 있다. 분자식 C19H27N5O5S, 분자량 437.51 g/mol이며, 옥소아세트산 모티프의 측쇄 변환에 의해 생성되는 산화성 카복실화 산물로서 니트로사민이나 전형적 유전독성 경고구조에 해당하지 않는다. 생성은 합성 공정, 가수분해 또는 저장 중 분해와 연관되는 경우가 많다. 구조 규명과 정량에는 ICH Q3A 및 Q3B의 불순물 프로파일링 요건에 따라 LC-MS/MS, 고분해능 LC-QTOF-MS, 그리고 보완적 NMR 분석이 통상 요구된다.
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