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Residual Solvent Testing
Residual Solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of pharmaceutical drug products.
On July 1st 2008, the USP implemented the new General Chapter <467> - "Residual Solvents", replacing the former USP Chapter <467> - "Organic Volatile Impurities"
As of July 2008 all drug substances, excipients and products in the USP-NF are subject to relevant control of residual solvents, even when no test is specified in the individual monograph. Testing is only required for solvents likely to be present i.e. those that have been used in the final step of production, or that have been used (and not removed) in earlier production steps.
The ILS Pharmaceutical Chemistry department has the capability and experience to undertake residual solvent analysis following the methods detailed in the USP and where required validating them for client specific products. ILS can also undertake residual solvent testing to client supplied methodology.
Residual Solvent analysis is always undertaken using GC (Gas Chromatography)
Contact ILS - for further information on residual solvent testing and analysis