Impureza Eltrombopag Ethyl Ester (CAS 3077185-45-3) é um subproduto estrutural identificado durante a síntese e processamento de Eltrombopag, caracterizada por um grupo éster etílico adicional. A sua identificação e quantificação exigem HPLC com gradiente acetonitrila-água e detecção UV, confirmação por LC-MS/MS e caracterização por RMN. Pode surgir por esterificação indesejada, transesterificação ou estabilidade em condições ácidas ou alcoólicas. Parâmetros críticos incluem perfil de retenção, massa exata, solubilidade em solventes orgânicos, limites de especificação em ppm conforme orientações ICH e validação de método segundo ICH Q2. Recomenda-se investigação da via de formação, testes de degradação forçada e estratégias de purificação para mitigação e garantia de conformidade de impurezas relacionadas.
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