Bicalutamide Related Compound A (CAS 945419-64-7) | também referido como Bicalutamide Sulfoxide | é uma impureza oxidativa observada durante a síntese e armazenamento do bicalutamida. Quimicamente corresponde à oxidação do enxofre do tioéter para sulfoxida | gerando alteração no perfil físico e químico da matéria prima. É identificada e quantificada por HPLC com detecção UV | LC-MS e ressonância magnética nuclear 1H/13C | e sua caracterização é crítica para controle de qualidade. Estratégias de mitigação incluem otimização de condições de reação | uso de agentes redutores e purificação por cromatografia ou recristalização. Limites e estudos de estabilidade devem seguir ICH Q3A e Q3B. Fornecemos material de referência e relatórios analíticos completos para avaliação e desenvolvimento de métodos de controle de qualidade.
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