Bacitracin EP Impurity E(CAS 22601-63-4)는 바시트라신과 연관된 정의된 펩타이드 불순물로, 분자식 C66H98N16O17S 및 분자량 1419.67 g/mol을 가진다. 이는 바시트라신의 고리형 펩타이드 복합체와 구조적으로 근접한 고분자량 유사체로, 발효, 정제 공정 또는 제한적 단백질분해에 의해 유래하는 제품 관련 이질성과 부합한다. 극성의 다기능성 펩타이드 골격 때문에 동정과 정량에는 일반적으로 역상 LC와 고분해능 MS 또는 LC-MS/MS가 필요하며, 보조적으로 UV 검출 및 필요 시 이온교환 프로파일링이 사용된다. 규제적 관점에서 이 불순물은 바시트라신 물질의 공정 유래 불순물과 조성 변동을 감시하는 데 의미가 있다.
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