4-Hydroxy Estrone (CAS 3131-23-5) é uma impureza oxidativa derivada da estrutura estrano | caracterizada pela hidroxilação no carbono 4 do núcleo esteroidal. Apresenta aumento de polaridade e absorvância UV distinta | facilitando sua identificação por HPLC-UV e LC-MS/MS com fragmentação específica m/z. Em controles analíticos deve ser avaliada por limites de especificação | perfil de retenção e comportamento em cromatografia reversa; sua presença pode indicar reações de oxidação durante síntese ou armazenamento. Métodos de quantificação validados | estabilidade forçada e estratégias de mitigação como antioxidantes e otimização de pH são recomendados para controlar níveis desta impureza e garantir conformidade regulatória.
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