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.
Descripción
N-Nitroso Diclofenac (CAS 66505-80-4) es una impureza relacionada con nitrosaminas derivada de diclofenaco, descrita formalmente como ácido 2-[2-(2,6-dicloro-N-nitrosoanilino)fenil]acético. Con fórmula molecular C14H10Cl2N2O3 y peso molecular de 325,15 g/mol, presenta un motivo N-nitroso arilamina asociado a preocupación genotóxica bajo los principios de ICH M7. Su formación puede producirse en condiciones nitrosantes, por exposición a nitrito residual o por vías de degradación oxidativa de la amina secundaria del compuesto progenitor. La elucidación estructural y la cuantificación a nivel traza suelen requerir LC-MS/MS, espectrometría de masas de alta resolución y, cuando la volatilidad lo permite, confirmación por GC-MS, con control de supresión iónica e interferencias isoméricas.
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