Roxadustat Impurity 13 (CAS 1809286-36-9) é uma impureza relacionada identificada no processo de síntese de Roxadustat e relevante para avaliação de qualidade. Sua presença pode afetar o perfil de pureza e a estabilidade do princípio ativo, exigindo caracterização físico-química detalhada por espectrometria de massas, RMN e análise cromatográfica HPLC/UPLC. A determinação de massa molar, padrões de fragmentação e comportamento de retenção suporta a identificação e quantificação. Métodos analíticos validados são essenciais para estabelecer especificações, limites aceitáveis e estratégias de controle durante desenvolvimento, produção e investigação de desvios, assegurando conformidade regulatória.
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