Darolutamide Impurity 1 (CAS 2407645-49-0) é um subproduto estruturalmente relacionado que apresenta núcleo 1H-pirazol-3-carboxamida com substituições 3-cloro-4-ciano e grupo 5-(1-hidroxietil). Esta impureza costuma originar-se em rotas de síntese de darolutamida por reações secundárias | etapas de proteção/desproteção ou degradação parcial | afetando o perfil de pureza do material ativo. A sua caracterização analítica por HPLC | LC-MS e RMN é essencial para determinar tempo de retenção | massa e sinais funcionais | e para estabelecer limites de aceitação conforme boas práticas. Medidas de controle incluem otimização de condições reacionais | purificação dirigida e validação de métodos analíticos.
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