리나글립틴 불순물 J, 즉 3-아미노피페리딘 불순물은 분자식 C5H12N2, 분자량 100.16 g/mol, CAS 54012-73-6의 염기성 지방족 고리형 디아민이다. 이 구조는 피페리딘 유래의 포화 아민에 해당하며, 이종고리 의약품 제조 과정에서 합성 중간체, 결합 반응 잔류물 또는 공정 유래 불순물로 생성될 수 있다. 발색단이 거의 없고 극성이 높아 미량 정량에는 일반적으로 LC-MS/MS, 이온쌍 LC, 또는 유도체화 후 GC-MS가 필요하며, 경우에 따라 모세관 전기영동이 적용된다. 아민 반응성을 가질 수 있는 공정 불순물로서 ICH Q3A 및 관련 시 ICH M7 관점에서 평가된다.
References
Chavan, Kamlesh, et al. “CHEMISTRY & BIOLOGY INTERFACE an Overview of Recent Development towards the Synthesis of Linagliptin a DPP- 4 Inhibitor.â€Â Chemistry & Biology Interface, vol. 10, no. 5, 2020, cbijournal.com/paper-archive/september-october-2020-vol-5/Review-Paper-1-an-overview-of-recent-development-towards-the-synthesis-of-linagliptin-a-dpp-4-inhibitor.pdf.
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