Residual solvents (Class I, Class II and Class III) – ICH guideline Q3c
Residual solvents are solvents that are used in the manufacturing of materials that are not completely removed after processing. For example, solvents can be used in glue and adhesive manufacturing to control the drying properties. There are guidelines for the amount of residual solvents that can be left behind and still be considered safe. At unsafe levels, they can either be harmful to the environment or humans. Residual solvents can also compromise the quality and/or functionality of the product.
Our GC Headspace is ideal for volatiles such as solvents as it can analyse the gaseous vapour formed from the rapid evaporation of the solvent itself. (Hence the term headspace analysis). Ethanol or Acetone are primary examples.
We can support your requirements whether it be manufacturing quality checks or determination of manufacturing impurities.
To support your requirements, we can also offer physical testing to determine other parameters that may be needed.
We have included some examples of various manufacturing impurities and solvents we work with on a regular basis:
Methyl tert-Butyl Ether (MTBA)
Methyl isobutyl ketone (MIBK)
Diethyl ether (Ether)
Details of our work with Elemental Impurities (Heavy Metal Residues) – ICH guideline Q3d
Details of our work with 5 Batch Analysis and Impurity Profiling