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.
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Descripción
El dímero N-nitroso piperazina, también denominado N,N’-dinitrosopiperazina o 1,4-dinitrosopiperazina (CAS 140-79-4), es una impureza simétrica de la clase de las nitrosaminas, con fórmula C4H8N4O2 y peso molecular de 144,13 g/mol. Puede originarse por nitrosación de intermedios o residuos que contienen piperazina en condiciones ácidas ricas en nitrito, y posee relevancia regulatoria porque las nitrosaminas se consideran con frecuencia impurezas potencialmente genotóxicas en el marco de ICH M7 y evaluaciones afines. Su detección y cuantificación suelen requerir LC-MS/MS o GC-MS con monitoreo selectivo de iones y fragmentación confirmatoria.
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