Azelaic Acid Inhouse Impurity C | identificado como ácido sebácico (CAS 111-20-6) | é um subproduto linear decanodioico (C10H18O4 | massa molar 202 | 25 g/mol) frequentemente observado em processos de síntese e purificação do ácido azelaico. Como impureza | altera o perfil de pureza | comportamento de cristalização e propriedades fisicoquímicas do lote | exigindo monitorização rigorosa por HPLC | GC-MS | LC-MS | RMN e FTIR. Estratégias de controle incluem otimização das etapas reacionais | ajustes de recristalização e separação cromatográfica para reduzir sua presença a níveis traço conforme especificações internas e requisitos regulatórios | minimizando impacto no desempenho do material final.
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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