Varenicline Hydroxy Impurity, CAS 357424-21-6, é o análogo oxigenado da vareniclina, com fórmula molecular C13H13N3O e massa molecular de 227,26 g/mol. A estrutura é compatível com uma impureza monohidroxilada de processo ou de degradação, resultante de modificação oxidativa do núcleo de vareniclina, e não corresponde à classe das nitrosaminas. A função polar adicional altera a retenção cromatográfica e dificulta a separação em nível traço em relação ao fármaco de origem e a análogos relacionados. A quantificação normalmente exige LC-MS/MS ou LC-MS de alta resolução, com confirmação ortogonal por RMN ou HPLC-UV após isolamento enriquecido. A avaliação regulatória segue princípios de perfil de impurezas e elucidação estrutural.
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