Sorafenib Aminophenoxy Impurity는 Sorafenib EP Impurity A, Sorafenib Impurity A로도 불리며, CAS 284462-37-9, 분자식 C13H13N3O2, 분자량 243.26 g/mol의 4-(4-aminophenoxy)-N-methylpicolinamide이다. 구조적으로 이는 소라페닙 합성과 연관된 아릴 에터 중간체로, 일반적으로 결합 반응의 불완전성 또는 아미노화 부족에 의해 생성된다. 니트로사민은 아니지만, 약전 불순물 프로파일링에서 공정 관련 불순물로 관리된다. 검출과 정량에는 LC-MS/MS 또는 고분해능 LC-MS가 통상 요구되며, 필요 시 HPLC-UV와 NMR로 보완 확인한다.
References
Johnsirani, P., et al. “LC-ESI-QTOF-MS Analysis Utilizing Gas-Phase Fragmentation Reactions Subjected to ESI-IS-CID and ESI-CID-MS/MS Conditions to Study the Degradation Behaviour of Sorafenib Tosylate: NMR and in Vitro Cytotoxicity and Apoptosis Detection Studies of Hydrolytic Degradation Products.” Journal of Pharmaceutical and Biomedical Analysis, vol. 177, Jan. 2020, p. 112881, https://doi.org/10.1016/j.jpba.2019.112881. ?
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