400 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-varenicline (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
설명
Varenicline Nitrosamine VRN-5000 Impurity는 Varenicline Impurity 9 및 N-Nitroso Varenicline으로도 불리며, 바레니클린 골격과 연관된 니트로사민 계열의 공정 또는 분해 불순물이다. CAS 2755871-02-2, 분자식 C13H12N4O, 분자량 240.26 g/mol. N-니트로소 화합물로서 니트로사민 위해성 평가와 ICH M7 원칙에 따라 검토되어야 하며, 극미량에서도 돌연변이원성 우려가 제기될 수 있다. 구조 확인과 정량에는 일반적으로 LC-MS/MS가 사용되며, 고분해능 MS와 필요 시 유도체화 또는 농축 후 GC-MS가 보완적으로 적용된다. 생성 경로는 합성, 정제 또는 저장 중의 니트로소화 조건과 연관될 수 있다.
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