Impureza de Abiraterona 10 é um subproduto identificado durante o desenvolvimento e controle de qualidade do princípio ativo | classificado quimicamente como Androst-5-en-17-one | 3-hydroxy- | [(3β)-3-hydroxyandrost-5-en-17-ylidene]hydrazone (3β) (9CI). Esta impureza apresenta perfil cromatográfico e espectrométrico distinto | sendo detectável por HPLC-DAD e LC-MS e confirmável por RMN para suporte estrutural. Informações sobre retenção | resposta detectora e comportamento sob condições aceleradas são essenciais para avaliação de pureza | limites aceitáveis e métodos indicativos de estabilidade. Produto indicado como referência analítica para investigação de degradação e validação de métodos conforme diretrizes ICH.
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