26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiethanolamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitrosodiethanolamine(NDIEA, CAS 1116-54-7)은 분자식 C4H10N2O3, 분자량 134.13 g/mol의 저분자 니트로사민 불순물이다. 이 화합물은 아질산염, 산성 조건 또는 공정 오염 하에서 디에탄올아민이 니트로소화되는 경로와 부합한다. N-니트로사민 계열에 속하므로, ICH M7을 포함한 최신 규제 체계에서 잠재적 유전독성 불순물로 평가된다. 검출 및 정량에는 일반적으로 동위원소 표지 내부표준을 사용하는 고선택성 LC-MS/MS 또는 GC-MS가 요구되며, 미량 수준, 휘발성, 매트릭스 효과 및 배경 오염으로 인해 분석 난도가 높다.
References
Fan, T. Y., Goff, U., Song, L., Fine, D. H., Arsenault, G. P., & Biemann, K. (1977). N-Nitrosodiethanolamine in cosmetics, lotions and shampoos. Food and Cosmetics Toxicology, 15(5), 423?430. https://doi.org/10.1016/s0015-6264(77)80007-2 ?
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