Eltrombopag Impurity 21은 저분자 트롬보포이에틴 수용체 작용제인 엘트롬보팍과 관련된 유연물질로, 단순 분해산물보다는 구조가 규정된 합성 부산물 또는 공정 유래 불순물로 해석하는 것이 타당하다. 분자식 C27H27N5O4, 분자량 485.54 g/mol이며, 원료의약품에 특징적인 헤테로방향족 및 카르복실레이트가 풍부한 골격을 유지한다. 평가는 일반적으로 ICH Q3A/Q3B에 부합하는 불순물 관리 체계에서 수행된다. 정확한 동정과 정량에는 LC-MS/MS, 고분해능 질량분석, 직교적 HPLC가 필요하며, 구조 배정에는 NMR이 보완적으로 사용된다. 명칭만으로는 특정 유전독성 경고를 시사하지 않지만, 발생 경로와 불순물 프로파일에 따라 독성학적 적격성 평가가 요구된다.
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