Diclofenac PPG Ester (Mixture PPG 1 & PPG 2) é uma impureza derivada da reação de esterificação entre diclofenaco e polipropilenoglicol | frequentemente encontrada como mistura de ésteres PPG 1 e PPG 2; conhecida também como diclofenac ppg ester. Apresenta perfil lipofílico e variação de massa molecular que afeta solubilidade | retensão em cromatografia líquida e estabilidade do princípio ativo. Detectável por HPLC com detector UV | LC-MS e GC-MS após derivatização | sua quantificação é crítica em controle de qualidade e estudos de estabilidade. A presença pode indicar condições de síntese incompletas ou contaminação por solventes e exige limites de especificação e estratégias de purificação para conformidade regulatória.
Referências
“Preparation and Characterization of PEG-Modified Polyurethane Pressure-Sensitive Adhesives for Transdermal Drug Delivery.†Drug Development and Industrial Pharmacy, 2021, www.tandfonline.com/doi/abs/10.1080/03639040802512235.Europe PMC. “Europe PMC.†Europepmc.org, 2016, europepmc.org/article/med/2670397.”
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