Azelaic Acid Inhouse Impurity D (CAS 1852-04-6) | também referida como undecanedioic acid | é uma impureza homóloga de cadeia C11 identificada no perfil de impurezas de azelaico. Quimicamente um diácido dicarboxílico linear | apresenta polaridade e solubilidade distintas que alteram o comportamento cromatográfico e o ponto de fusão do material final. Sua presença indica variação na matéria-prima ou reações secundárias durante oxidação e pode influenciar pureza | estabilidade e propriedades físico-químicas do lote. A detecção e quantificação são típicas por LC-MS | HPLC com detector apropriado ou GC-MS após derivatização. Estratégias de controlo incluem otimização de processo | purificação por cromatografia e critérios analíticos de especificação.
Referências
Breathnach, A.S. “Pharmacological Properties of Azelaic Acid.†Clinical Drug Investigation, vol. 10, no. Supplement 2, 1995, pp. 27–33, 10.2165/00044011-199500102-00005. Accessed 4 Feb. 2020.
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