26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N,N′‑Di‑nitrosopiperazine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Condição de envio
Ambient Temperature
Descrição
O dímero N-nitroso piperazina, também denominado N,N’-dinitrosopiperazina ou 1,4-dinitrosopiperazina (CAS 140-79-4), é uma impureza simétrica da classe das nitrosaminas, com fórmula C4H8N4O2 e massa molar de 144,13 g/mol. A substância pode formar-se por nitrosação de intermediários ou resíduos contendo piperazina sob condições ácidas ricas em nitrito, e é regulatoriamente relevante porque nitrosaminas são frequentemente tratadas como impurezas potencialmente genotóxicas no âmbito da ICH M7 e avaliações correlatas. Devido às baixas concentrações esperadas e à complexidade matricial, a detecção e a quantificação normalmente exigem LC-MS/MS ou GC-MS com monitoramento seletivo de íons e fragmentação confirmatória.
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