Edwards' Analytical is again expanding their range of equipment in the lab to increase the analytical services range they can offer customers. The acquisition of a new Perkin Elmer GC-FID with a 110 position headspace auto sampler. This will enable Edwards' Analytical to offer a quick and relatively simple technique for the identification and quantification of Volatile Organic Compounds (VOC’s). With applications in many industries, including; pharmaceuticals, print and packaging, food and beverages and cosmetics. Edwards' Analytical can particularly help your company satisfy USP <467> requirements for these residual solvents.
Organic Volatile Impurities, generally referred to as ‘residual solvents’, are a by-product of the manufacturing process of certain products. These chemical residues can also form during packaging and storage and it is the responsibility of the product manufacturer that these residues are only present in specified limited concentrations according to USP <467> and ICH guidelines. Testing has been required for all products, drug substances and excipients found in the USP-National Formulary following the implementation of the General Chapter ‘Residual Solvents’ <467> in July 2008. Additionally, testing is required for solvents likely to be present in a product. This means analysis is required for those solvents remaining in the finished product that were used during production and any additional solvents used at the final stage.
GC Headspace Chromatography is an extremely useful technique for both qualitative and quantitative determination of residual solvents. The sample of interest is placed in a chromatography vial in a condensed state, where the volatile substances in the sample diffuse into the gas phase, forming the headspace. Successful partitioning of the residual solvents for samples that are more difficult to separate can be overcome by lowering the partition coefficient via methods such as increasing temperature or the addition of inorganic salts. In addition, the phase ratio (gas volume in the headspace compared to sample size) can be lowered (increase the sample size) to produce a higher residual solvent yield. Sensitivity of specific compounds which are more challenging to detect, such as amines and alcohols, can be improved with the addition of derivatization reagents. Once equilibrium of the sample phase and gas phase is reached, a sample is taken from the headspace of the gas and injected into the GC-FID for identification and quantification of residual solvents.
As a quick and reliable method, GC Headspace is a cost effective solution for many industries for QC and sample screening purposes.
To request further information or to discuss your business requirements please contact us on 01325 311263 or email firstname.lastname@example.org.