Azelaic Acid Monomethyl Ester (CAS 2104-19-0) é uma impureza identificada em matérias primas e sintéticos contendo ácido azelaico. Do ponto de vista técnico | apresenta ponto de fusão e solubilidade diferenciados que afetam a pureza do lote e o perfil de dissolução. Sua identificação e quantificação são realizadas por HPLC com detector UV | GC-MS para confirmação de massa e RMN para elucidação estrutural. Métodos de controle de qualidade devem incluir limites de especificação | estudos de estabilidade e ensaios de degradação forçada para avaliar formação sob condições ácidas | básicas e oxidativas. A validação analítica assegura limites de detecção | robustez e recuperação em matrizes complexas.
Referências
Del Rosso, James Q. “Azelaic Acid Topical Formulations: Differentiation of 15% Gel and 15% Foam.†The Journal of Clinical and Aesthetic Dermatology, vol. 10, no. 3, 1 Mar. 2017, pp. 37–40, www.ncbi.nlm.nih.gov/pmc/articles/PMC5367880/.
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