Maribavir Impurity 11 (CAS 176161-56-1) é uma impureza identificada no perfil de matéria-prima e produto intermediário do processo de síntese do maribavir, podendo originar-se como subproduto de reação ou produto de degradação; sua presença impacta diretamente no perfil de impurezas e na avaliação de risco do material. A caracterização estrutural e a quantificação são essenciais para o controle de qualidade, recomendando-se análise por HPLC com detector UV e LC-MS/MS para rastreio e quantificação, com confirmação por RMN para elucidação estrutural. Estudos de formação e testes de estabilidade acelerada orientam pontos críticos do processo e estratégias de mitigação, enquanto a definição de limites aceitáveis deve seguir ICH Q3A e Q3B e integrar o controle em liberação de lotes.
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