Sorafenib Inhouse Impurity C é um subproduto identificado durante etapas avançadas da síntese do princípio ativo | cuja monitorização é crítica para garantir qualidade farmacêutica. Caracteriza-se por um perfil cromatográfico e massas específicas detectáveis por HPLC e LC-MS e por sinais confirmatórios em RMN. A presença pode revelar vias de degradação ou reações secundárias | afetando pureza e estabilidade do lote. Estratégias analíticas incluem quantificação por HPLC validado | caracterização estrutural por LC-MS/MS e RMN | e estabelecimento de limites de especificação e pontos de controle no processo para redução e remoção eficientes desta impureza.
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