Residual Solvents and OVI Testing

We provide expert determination and identification of residual solvents in pharmaceutical articles, helping customers ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is prudent to ensure residual solvents are controlled for all excipients and the drug substance(s) in order to ensure that the finished product will meet the limits specified in ICH Q3C(R5) or USP <467> or the limit established by the drug product manufacturer for unique solvent(s). Our Good Manufacturing Practice (cGMP) laboratories routinely conduct residual solvent testing in accordance with pharmacopoeia methods, in particular USP <467>, and Ph. Eur. 5.4 for residual solvents. Additionally, we are also able to develop and validate tailored methods that will meet your specific needs using a range of techniques such as headspace-gas-chromatography or gas-chromatography-mass spectrometry (GC-MS).