Impureza (Z)-2-Nonenedioic Acid (CAS 104360-82-9) é um isômero insaturado frequentemente detectado em lotes de ácido azelaico e relevante para controle de qualidade. Sua presença reduz a pureza assinalada e pode afetar análises cromatográficas por apresentar tempo de retenção próximo ao composto principal. A detecção e quantificação são realizadas por HPLC com detector UV e por GC-MS para perfis de fragmentação | com confirmação estrutural por RMN 1H e 13C quando exigido. O acompanhamento conforme diretrizes ICH e especificação de limites aceitáveis garante mitigação de riscos toxicológicos e garantia da estabilidade do produto.
Referências
Nazzaro-Porro, Marcella. “Azelaic Acid.†Journal of the American Academy of Dermatology, vol. 17, no. 6, 1 Dec. 1987, pp. 1033–1041, www.sciencedirect.com/science/article/abs/pii/S0190962287702941, 10.1016/S0190-9622(87)70294-1. Accessed 28 Jan. 2022.
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