1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-diclofenac (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
설명
N-Nitroso Diclofenac(CAS 66505-80-4)은 디클로페낙 유래의 니트로사민 관련 불순물로, 화학명은 2-[2-(2,6-dichloro-N-nitrosoanilino)phenyl]acetic acid이다. 분자식 C14H10Cl2N2O3, 분자량 325.15 g/mol이며, N-니트로소 아닐린 구조를 포함하므로 ICH M7 관점에서 잠재적 유전독성 우려가 제기된다. 생성은 니트로사화 조건, 잔류 아질산염 노출, 또는 모체 화합물의 2차 아민 기능과 관련된 산화적 분해 경로에서 발생할 수 있다. 극미량 검출과 정량에는 일반적으로 LC-MS/MS, 고분해능 질량분석법, 그리고 휘발성이 허용되는 경우 GC-MS 확인이 요구되며, 이온 억제와 이성질체 간섭에 대한 주의가 필요하다.
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