High Resolution Gas Chromatography
For regulated test materials reaching the detection limits required in such markets as the Pharmaceutical, Medical Device and AgroSciences requires the latest generation of GC technology. Impact Analytical has brought on board the latest edition Shimadzu Nexis GC-2030 coupled with a TQ8050 NX MS/MS Detector and an HS-20 headspace analyzer. This new hardware provides quantitative GC-MS/MS analyses of ultra-trace amounts, down to the femtogram level. What are some common areas where this technology is useful?
The most common biological samples tested by GC-MS/MS are plasma or serum for pharmacokinetics, drug clearance, half- life, and bioavailability. Urine samples may be tested to better understand biological elimination of the compound of interest.
The GC-MS/MS is used in the Agrosciences space for targeted (MRM mode) and non-targeted (scan mode) studies of small molecules. The MRM mode affords ppt levels of sensitivity for most pesticides, herbicides, and insecticides.
The GC-MS/MS can be used to determine many impurities and degradation products across various platforms. In addition to achieving very low levels of Volatile Organic Compounds (VOCs) a new pharmaceutical concern has recently emerged. N-nitroso dimethylamine (NDMA) and other nitrosamines are impurities found in some prescription medications. These compounds have been identified by the FDA as materials of concern and need to be tested for. One method for analyzing for these compounds is made using HR-GC/MS according to the FDA website.
Extractable and leachable studies look for trace amounts of substances which may come out of a specific project. GC-MS/MS is a technique to allow extremely low detection and quantitation of potentially harmful materials.