A Impureza A da Trazodona BP, identificada como trazodona N1-óxido (CAS 55290-68-1), é o metabólito N-óxido e produto de degradação relacionado ao processo do antidepressivo trazodona, um derivado triazolopiridínico com piperazina. A oxidação do nitrogênio terciário da piperazina origina um N-óxido heteroaromático polar, com fórmula molecular C19H22ClN5O2 e massa molecular de 387.86 g/mol. Sua formação pode ocorrer sob estresse oxidativo, durante o armazenamento ou na manipulação analítica da amostra. A quantificação em traços geralmente requer LC-MS/MS com confirmação por MS de alta resolução, complementada por HPLC-UV para o perfil cromatográfico e, quando necessário, LC-HRMS para elucidação de impurezas. Não é uma nitrosamina, mas permanece relevante para qualificação de impurezas e estudos de degradação sob estruturas ICH.
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