Residual solvents in pharmaceuticals are defined as volatile organic compounds used in or generated from the manufacture of drug substances, pharmaceutical additives, or drug products. They are strictly controlled according to risk classifications from Class 1 to Class 3, which are based on the risk to human health.
Headspace GC methods specified in the USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents, are commonly used for analysis of residual solvents. These USP methods were created based on the analytical methods specified in the EP (European Pharmacopoeia), in accordance with policies specified by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
This Application Data Sheet presents data obtained using the Shimadzu HS-20 Headspace Sampler and Shimadzu GC-2010 Plus Gas Chromatograph, from Class 1 and Class 2 standard solutions, in accordance with Water-Soluble Articles, Procedure A, in USP <467> Residual Solvents.