A impureza nitroso 1 de bilastina, também denominada N-nitroso bilastina, é uma impureza de processo ou degradação relacionada a nitrosaminas, resultante da nitrosação de uma amina secundária. O número CAS é 2731008-04-9, e a composição C12H14N4O corresponde a massa molecular de 230,3 g/mol. Como nitrosamina estrutural, é relevante na avaliação de impurezas genotóxicas segundo a ICH M7, pois espécies N-nitroso podem apresentar reatividade com o DNA. A determinação em nível de traço geralmente exige métodos ortogonais de alta sensibilidade, sobretudo LC-MS/MS, complementada por LC-HRMS para confirmação estrutural e, quando a volatilidade permite, GC-MS.
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