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.
Shipping Condition
Ambient Temperature
Beschreibung
N-Nitroso-piperazin-Dimer, auch N,N‘-Dinitrosopiperazin oder 1,4-Dinitrosopiperazin genannt (CAS 140-79-4), ist eine symmetrische Nitrosamin-Verunreinigung mit der Summenformel C4H8N4O2 und einer Molmasse von 144,13 g/mol. Die Verbindung kann durch Nitrosierung piperazinhaltiger Zwischenprodukte oder Rückstände unter sauren, nitritreichen Bedingungen entstehen und ist regulatorisch relevant, da Nitrosamine im Rahmen von ICH M7 und verwandten Bewertungen häufig als potenziell genotoxische Verunreinigungen eingestuft werden. Für den Nachweis und die Quantifizierung sind wegen geringer Gehalte und komplexer Matrizes in der Regel LC-MS/MS oder GC-MS mit selektivem Ion Monitoring und Bestätigungsfragmentierung erforderlich.
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