Ampicillin EP Impurity E, 즉 ampicillinyl-D-phenylglycine은 베타-락탐 화학에 속하는 공정 유래 penam 불순물로, ampicillin 합성 중 측쇄 교환 또는 가수분해성 분해와 연관된다. CAS 1207726-28-0, 분자식 C24N4O5S가 아니라 C24H26N4O5S, 분자량 482.6 g/mol을 갖는다. 구조적으로 ampicillin 골격과 D-phenylglycine 유래 부분이 결합된 형태이므로, 유사한 극성과 관련 아마이드 종과의 질량분석 중첩 때문에 불순물 프로파일링이 어려울 수 있다. 규제적 식별과 정량에는 일반적으로 LC-MS/MS, 고분해능 LC-MS 및 불순물 특이적 HPLC가 요구되며, UV 검출만으로는 명확한 할당이 부족한 경우가 많다.
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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