N-Hidroxi lenalidomida (CAS 2717380-87-3) | também conhecida como Lenalidomide Impurity 44 | é uma impureza identificada no perfil de degradação e metabolismo da lenalidomida. Caracteriza-se por uma modificação N-hidroxilada do núcleo heterocíclico e requer monitorização por cromatografia líquida de alta eficiência com deteção por espectrometria de massas e confirmação por RMN. A quantificação robusta e a validação de método permitem estabelecer limites de especificação e avaliar o risco em matérias-primas e formulações. Fornecem-se dados analíticos | padrões de referência e relatórios de caracterização para suporte ao controlo de qualidade e estudos de estabilidade.
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