Residual Solvents and Organic Volatile Impurities (OVI) Analysis

Our pharmaceutical impurities analysis team provide expert determination and identification of residual solvents, delivered from our GMP compliant laboratories, to help you to 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) to ensure that the finished product will meet the limits specified in ICH Q3C 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. (general text 5.4 and general chapter 2.4.24). Additionally, we are also able to develop and validate tailored methods that will meet your specific needs using a range of chromatographic techniques such as headspace-gas-chromatography or gas-chromatography-mass spectrometry (GC-MS). Our pharmaceutical analysis experts conduct residual solvent method validation which conforms to ICH Q2 guidelines on validation of analytical procedures. The accurate and robust data generated for residual solvents can help you to make an appropriate risk-based assessment for your finished drug product(s).