Informações adicionais sobre o Cabozantinib Impurity 8 (Na Salt)
Fármaco de origem
Cabozantinib
Nome IUPAC
1-((4-((6, 7-dimethoxyquinolin-4-yl)oxy)phenyl)carbamoyl)cyclopropane-1-carboxylate, sodium salt (1:1)
Sinônimos
N/A
Descrição
Cabozantinib Impurity 8 (Na Salt) é uma impureza relacionada ao cabozantinibe detectada em etapas de síntese e em testes de estabilidade. Caracterizada por cromatografia líquida de alta eficiência HPLC | espectrometria de massas e RMN | apresenta massa molecular e padrões espectrais que permitem identificação precisa e quantificação sensível. Seu perfil fisicoquímico e possíveis vias de formação exigem controle rigoroso como atributo crítico de qualidade | com limites especificados e protocolos validados para amostragem | extração e análise. Fornecida como padrão de referência analítico | suporta desenvolvimento de métodos | validação e investigação de desvio | reduzindo risco regulatório e variabilidade entre lotes.
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