Methyl 4-(2-(1 | 3-dioxoisoindolin-2-yl)ethoxy)-3-oxobutanoate (CAS 111429-90-4) | conhecido como Amlodipine Impurity 10 | é uma impureza estrutural observada em processos de síntese e purificação de amlodipina. Essa impureza apresenta um núcleo isoindolinona ligado a um éter etílico e a um éster metílico beta-ceto | conferindo polaridade moderada e comportamento cromatográfico distinto. A detecção e quantificação são realizadas por HPLC com detecção UV | LC-MS e espectroscopia de RMN para confirmação estrutural e identificação de isómeros. A presença desta impureza pode afetar o perfil de pureza e exigências regulatórias | tornando essencial a validação de métodos analíticos e limites de especificação.
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