La impureza nitroso 1 de bilastina, también denominada N-nitroso bilastina, es una impureza de proceso o degradación relacionada con nitrosaminas, originada por la nitrosación de una función amina secundaria. Su número CAS es 2731008-04-9, y la fórmula C12H14N4O corresponde a un peso molecular de 230.3 g/mol. Como nitrosamina estructural, es pertinente en la evaluación de impurezas genotóxicas según ICH M7, dado que las especies N-nitroso pueden presentar reactividad frente al ADN. La detección a nivel traza suele requerir técnicas ortogonales de alta sensibilidad, especialmente LC-MS/MS, complementada por LC-HRMS para confirmación estructural y, cuando la volatilidad lo permite, GC-MS.
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