Farmasötik Ürünlerde Tüketilebilirlik Çalışmalarına Analitik Yaklaşımlar

Abstract

Ignoring the effects of extractable substances not only creates great difficulties for drug manufacturers and regulations, but also changes the safety of the drug due to the dangers that impurities may cause. The suitability of these material components and production conditions in terms of the safety of the drug should be evaluated in the development stages before production. There is still little information about extractable substances in pharmaceutical products, especially those of organic structure. Because of the potential adverse effects of impurities on users of pharmaceutical products and the major challenges they pose to regulations and pharmaceutical manufacturers, they need to be carefully identified and comprehensively managed. Current regulations regarding safety analyzes are either insufficient or quite harmful for green chemistry. In this thesis study, stoppers with different structures (bromobutyl and chlorobutyl) were used with different solvents (n-hexane, isopropyl alcohol, dichloromethane, water, Tween-80, acidic and basic solutions) and extraction methods (soxhalet, reflux and solid phase extraction). At the end of all extraction processes, the extractables were evaluated by GC-MS, LC-qTOF-MS and ICP-MS, and the effects of all extraction processes on the analytes and green chemistry were evaluated. Extractable substances were evaluated according to extraction method, solvent and risk.