O éster PEG da indometacina é uma impureza relacionada ao processo que surge por esterificação do grupo carboxílico com poli-etilenoglicol | apresentando maior massa molar e polaridade que o princípio ativo | o que altera seu comportamento físico e cromatográfico; por isso é crítico no controle de qualidade. Deve ser identificado e quantificado por métodos validados como HPLC reverso acoplado a LC-MS e confirmação por RMN | pois pode interferir na assay | estabilidade e perfil de dissolução. Estratégias de mitigação incluem otimização das condições de reação | seleção de solventes | etapas de purificação específicas e definição de limites aceitáveis conforme diretrizes regulatórias aplicáveis.
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