Amiodarone Related Compound G / 1-Methoxy Amiodarone
설명
아미오다론 EP 불순물 G는 Amiodarone Related Compound G 또는 1-Methoxy Amiodarone으로도 불리며, 벤조푸란계 항부정맥제 아미오다론의 구조가 규정된 방향족 에터 불순물이다. CAS 1087223-70-8, 분자식 C26H31I2NO4, 분자량 675.34 g/mol을 가지며, 모화합물의 페놀성 산소가 O-메틸화된 구조에 해당한다. 이러한 유도체는 일반적으로 산화 분해보다 합성 기원 부산물 또는 공정 관련 불순물로 형성된다. 검출과 정량에는 요오드 치환체의 특이한 이온화 거동과 유사 유도체와의 높은 크로마토그래피적 근접성 때문에 LC-MS/MS 및 고해상도 LC-MS가 통상 필요하며, NMR과 LC-UV가 보조적으로 사용된다.
References
Karmarkar, S., et al. “Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 100, Nov. 2014, pp. 167–74, https://doi.org/10.1016/j.jpba.2014.07.002.
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