26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-escitalopram (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Nitroso-Escitalopram ESTRC-1, también denominado N-Nitroso Desmethylcitalopram, es una impureza de tipo nitrosamina asociada al espacio químico de citalopram y escitalopram. Con fórmula molecular C19H18FN3O2 y peso molecular de 339.36 g/mol, presenta la funcionalidad N-nitroso sobre el esqueleto amínico desmetilado. Estas especies pueden formarse por nitrosación de precursores de amina secundaria durante el proceso o el almacenamiento, y en el marco de ICH M7 se consideran potencialmente mutagénicas, por lo que suelen requerir evaluación toxicológica específica. Su caracterización depende habitualmente de LC-MS/MS con confirmación por espectrometría de alta resolución, mientras que GC-MS puede emplearse cuando la volatilidad y la estabilidad térmica lo permiten. La cuantificación exige control estricto de contaminación traza y efectos de matriz.
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