Calcitriol Impurity 29 (CAS 144848-24-8) é uma impureza relacionada ao composto calcitriol identificada em estudos de síntese e degradação; caracteriza-se por comportamento cromatográfico distinto e é monitorada por HPLC com detecção UV e LC-MS para quantificação e confirmação de massa. Elucidação estrutural recorre a RMN e espectrometria de massas de alta resolução. Avaliação técnico-regulatória inclui estabelecimento de limites de aceitação | estudos de estabilidade forçada e investigação de vias de formação. Informação analítica robusta permite desenvolvimento de métodos validados para controle de qualidade e gerenciamento de riscos em processos de fabricação farmacêutica.
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