Abacavir EP Impurity A, CAS 136470-79-6은 뉴클레오사이드 역전사효소 억제제 아바카비르와 연관된 구조 규명형 공정 유래 불순물이다. 분자식 C14H18N6O, 분자량 286.33 g/mol의 헤테로방향족 아미노 유도체로서, 일반적으로 트리아진 함유 골격의 합성 중간체 또는 부반응에서 기원하는 것으로 해석된다. 구조 확인과 극미량 정량에는 LC-MS/MS, 고분해능 LC-MS, 그리고 UV 검출을 갖춘 HPLC 또는 UPLC의 정합적 적용이 필요하다. 규제 관점에서는 관련물질로 관리되며, 해당 시 ICH M7에 따른 변이원성 위험 평가의 대상이 된다.
References
Kurmi, Moolchand, et al. “Stability Behaviour of Antiretroviral Drugs and Their Combinations. 5: Characterization of Novel Degradation Products of Abacavir Sulfate by Mass and Nuclear Magnetic Resonance Spectrometry.” Journal of Pharmaceutical and Biomedical Analysis, vol. 134, Feb. 2017, pp. 372–84, https://doi.org/10.1016/j.jpba.2016.10.019. ?Vukkum, Pallavi. “Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination
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