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.
Descrição
N-Nitroso Diclofenac (CAS 66505-80-4) é uma impureza relacionada a nitrosaminas derivada do diclofenaco, formalmente designada ácido 2-[2-(2,6-dicloro-N-nitrosoanilino)fenil]acético. Com fórmula molecular C14H10Cl2N2O3 e massa molecular de 325,15 g/mol, apresenta um motivo N-nitroso arilamina associado a preocupação genotóxica segundo os princípios da ICH M7. Sua formação pode ocorrer sob condições nitrosantes, por exposição a nitrito residual ou por vias de degradação oxidativa envolvendo a função amina secundária do composto parental. A elucidação estrutural e a quantificação em nível traço geralmente exigem LC-MS/MS, espectrometria de massas de alta resolução e, quando a volatilidade permite, confirmação por GC-MS, com atenção a supressão iônica e interferências isoméricas.
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