Intertek ASG Laboratory, Manchester, UK

Pharmaceutical Organic Volatile Impurity (OVI) and Residual Solvent Analysis

Intertek ASG is able to offer a range of techniques for the identification and quantification of organic volatile impurities in pharmaceutical products, to the appropriate ICH guidelines as described in ICH Topic Q3C. ASG is able to assure clients that organic volatile impurities and residual solvents have been reduced to the acceptable level in manufacture of drug substance, excipients and drug products.

Specific expertise Intertek ASG can bring to bear includes:

GC
Headspace GC
GCMS
Gravimetric techniques
Method development to ICH guidelines

Intertek ASG is able to carry out the analysis of specialist and toxic volatiles such as Ethylene Oxide (EO), Propylene Oxide (PO) and acrylate monomers. In addition Intertek ASG is able to draw on wider expertise within the international Intertek Outsourced Laboratory network. All work can be carried out to GLP or cGMP standards as dictated by customer requirements.