암피실린 하이단토인 아날로그는 분자식 C17H17N3O5S, 분자량 375.4 g/mol의 반합성 beta-lactam 관련 불순물이다. 구조적으로는 암피실린의 고리 전환형 분해산물로, 페니실린 골격에서의 분자내 재배열 또는 가수분해 경로 이후 하이단토인 형성이 관여했을 가능성이 있다. 이러한 변환 생성물은 산성, 열적 또는 산화적 스트레스 조건에서 나타날 수 있어 안정성 평가에서 중요하다. 확인 및 정량에는 분자 이온 확인을 위한 LC-MS/MS가 일반적으로 필요하며, 구조 규명을 위해 LC-HRMS와 NMR이 사용된다. 규제 관점에서는 약전 및 ICH 불순물 관리 원칙에 따른 적절한 불순물 자격평가가 요구된다.
References
Swami, Onkar C. “Ampicillin: Rise Fall & Resurgence.” JOURNAL of CLINICAL and DIAGNOSTIC RESEARCH, 2014, www.ncbi.nlm.nih.gov/pmc/articles/PMC4080027/, 10.7860/jcdr/2014/8777.4356.
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