Losartan Impurity 12 (CAS 2353190-33-5) | 5-(Azidomethyl)-2-butyl-4-chloro-1H-imidazole | é uma impureza relacionada de síntese identificada durante etapas industriais de produção de losartana; estruturalmente apresenta um núcleo imidazólico substituído com grupo azida | conferindo propriedades de polaridade e solubilidade que impactam extração e purificação. Detectável por cromatografia líquida de alta resolução com detecção UV e espectrometria de massas | sua quantificação e perfil de pureza são críticos para conformidade analítica e limites regulatórios. Estudos de estabilidade e de degradação em meios ácido | básico e térmico definem estratégias de controle do processo e validação analítica.
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