1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-enalapril (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
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Ambient Temperature
설명
N-Nitroso Enalapril, CAS 2994317-06-3은 에날라프릴의 아민 기능기가 N-니트로소화되어 생성되는 니트로사민 불순물이다. 분자식 C20H27N3O6, 분자량 405.5 g/mol로서, ICH M7 원칙과 니트로사민에 대한 규제 요구에 따라 엄격히 평가되는 잠재적 유전독성 오염물질에 속한다. 형성은 합성 공정 중, 니트로소화제 노출 시, 또는 2차 아민의 니트로소화를 촉진하는 조건에서 발생할 수 있다. 극미량 정량에는 일반적으로 LC-MS/MS가 요구되며, 필요 시 HRMS 및 유도체화 후 GC-MS가 보완적으로 사용된다.
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