Diclofenac Impurity 49 (CAS 84803-53-2) é uma impureza observada em lotes de diclofenaco | caracterizada como um derivado salino com polaridade aumentada em relação ao fármaco pai. Pode resultar de reações secundárias durante a síntese ou de degradação hidrolítica | afetando o perfil de pureza e estabilidade. É detectável e quantificável por HPLC com detecção UV e por LC-MS para confirmação de massa | e sua identificação exige caracterização por RMN e infravermelho. O controle analítico desta impureza | definição de limites e integração nos protocolos de controle de qualidade são essenciais para conformidade regulatória.
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