Informações adicionais sobre o Azelaic Acid Impurity 1
Fármaco de origem
Azelaic Acid
Nome IUPAC
9-ethyl 1-methyl (E)-non-2-enedioate
Descrição
A Impureza 1 do ácido azelaico é um subproduto sintético identificado por similaridade estrutural ao composto principal | frequentemente manifestando diferença de polaridade e ponto de fusão que afeta cristalização e pureza de lote; sua presença é detectável por HPLC com detecção UV | GC-MS para voláteis remanescentes e espectroscopia NMR para confirmação estrutural. Esta impureza pode comprometer titulação | perfil de estabilidade e formulabilidade | exigindo limites específicos em especificações de qualidade e controles analíticos robustos. Estratégias de mitigação incluem otimização de etapas de reação | purificação por recristalização e cromatografia e monitoramento segundo diretrizes ICH e práticas GMP para garantir conformidade e segurança do material.
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