Apixaban Carboxylic Acid Impurity, CAS 503614-92-4는 Xa 억제제 아픽사반에서 유래한 구조가 규정된 공정 관련 또는 분해 관련 불순물로, 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxylic acid에 해당한다. 분자식은 C25H24N4O5, 분자량은 460.48 g/mol이며, 헤테로방향족 핵의 카복실산 유도체이다. 형성은 피라졸로피리딘 골격 구축 중의 가수분해성 경로 또는 합성 부반응에서 기인할 수 있다. 비휘발성이고 극성을 띠므로, 동정과 정량에는 일반적으로 LC-MS/MS, 고분해능 MS, 그리고 HPLC-UV의 직교적 방법이 필요하며, ICH Q3A/Q3B 원칙에 따라 평가된다.
References
Budovich, Aliaksandr, et al. “Role of Apixaban (Eliquis) in the Treatment and Prevention of Thromboembolic Disease.” Pharmacy and Therapeutics, vol. 38, no. 4, 1 Apr. 2013, pp. 206–231, www.ncbi.nlm.nih.gov/pmc/articles/PMC3684191/#b5-ptj3804206. Accessed 24 Jan. 2022.
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