Residual solvent and organic volatile impurity testing.
What is Gas Chromatography?
Gas chromatography is the separation and analysis of compounds that be vaporized into gaseous form without affecting the critical constituents. Our GC is also equipped with a Headspace auto-sampler which allows the analysis of volatile organic compounds in a sample.
Why do we do it?
Assessing the constituent parts of a finished pharmaceutical product, raw material or API is an essential stage in determining product safety. It is a regulatory requirement defined within every pharmacopoeia that products, both sterile and non-sterile, must be assessed for their chemical quality. As such, each product must have an associated, validated method for chemical analysis which is performed routinely on every batch.
Gas Chromatography has the advantage of being able to analyse volatile compounds. At Honeyman equipped with our headspace auto-sampler we are able to perform highly specialised testing such as:
- Residual solvents testing
- Headspace testing to USP <467>
GC analysis is typically faster than HPLC with a comparatively better resolution.
How can we help assure compliance?
Utilizing specific GC columns and pressures – GC allows the separation of analytes within a vaporised mixture. The gaseous mobile phase containing the sample is usually Helium passing through a column of adsorbent solid stationary phase. Our GC instrumentation is fitted with a Flame Ionization Detector (FID) which is designed for the analysis of organic and hydro carbon compounds. Some examples of the analysis we perform using GC are:
- Purity Assay
- Related Substances
- Residual Solvents