Givinostat-O-Glucuronide é uma impureza de interesse analítico derivada da glucuronidação do inibidor histona deacetilase Givinostat. Esta impureza conjugada apresenta massa e polaridade aumentadas que afetam retenção em cromatografia e resposta em detecção por LC-MS | exigindo métodos validados para separação e quantificação. Caracteriza-se por sinais espectrais específicos e necessidade de controles de estabilidade | pois sua formação indica biotransformação ou contaminação cruzada durante síntese ou formulação. O perfil de impurezas deve ser monitorado por HPLC com detecção UV e espectrometria de massas | determinando limites de aceitação | estabilidade e impacto sobre a pureza global do lote.
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