Detektion von Restlösemitteln als Verunreinigungen in Arzneistoffen mittels Headspace-GaschromatographieI: Qualitativer Nachweis / 1. Teil: MethodenbeschreibungKerstin Brinkmann und Siegfried Ebel Institut für Pharmazie und Lebensmittelchemie der Bayerischen Julius-Maximillians-Universität, Würzburg Detection of Residual Solvents as Impurities in Drug Substances by Headspace-gaschromatography / I: Detection / Part 1: Method description A screening method for detection of residual solvents in drug substances in described. Separation is done by capillary gas chromatography using headspace technique. The separation includes all residual solvents given by the ICH Guideline on these impurities. There are some critical pairs or not separated peaks. In this case another stationary phase is used. Key words Headspace-Kapillar-Gaschromatographie · Restlösemittel, Screening-Verfahren |
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pharmind 1999, Nr. 3, Seite 263