Lee Marotta | Authors


Meeting the Updated Requirements for the Determination of Residual Solvents in Pharmaceutical Materials

The United States Pharmacopeia (USP) has implemented a revised method for the determination of residual solvents, chapter 467; this revision has brought the methodology of USP 467 into close alignment with European Pharmacopeia (EP) method 2.4.24. The USP and EP determination of class 1 and class 2 residual solvents is performed with static headspace (HS) sample introduction and gas chromatography (GC) with flame ionization detection (FID); class 3 has flexibility in the technique, however, it is often included in the HS analysis.