Choosing a Specialised Detector for Nitrosamine Analysis in Pharmaceutical Drugs

Over the Past few years the news has seen many high-profile product recalls of various pharmaceutical drugs that have been found to contain nitrosamines. Nitrosamine are carcinogenic compounds so need to be monitored to ensure unsafe levels are not found in consumer products. Governments around the world are now requiring reporting on Nitrosamine Levels. With manufacturers often finding the analysis anything but simple, with common issues including achieving the required detection limits and false positives.

The Ellutia 800 Series TEA is the ideal detector for nitrosamine analysis thanks to its selectivity and sensitivity for Nitroso compounds. The TEA is a chemiluminescence detector that can be interfaced to a GC, HPLC system or a total nitrosamine analysis system. In GC operation the TEA works by using a pyrolyser to cleave the NO group from compounds as they elute from the GC column. This NO group is then reacted with ozone which produces a photon of light which is detected.

For testing of pharmaceutical drugs, The 800 Series TEA can be interfaced to a chemical stripping system that allows for rapid testing of ATNC (Apparent Total N-nitrosamine content). This uses a chemical reaction to remove the NO group rather than a pyrolyser. This technique quickly gives an accurate result for the total nitrosamine content of a sample showing both volatile and non-volatile components in a single result. 

Any positive sample can then be further analysed by an 800 Series TEA interfaced to a GC where volatile nitrosamines such as NDMA (N-Nitrosodimethylamine) can be separated and quantified.

For further information on how the Ellutia 800 Series TEA can help with the detection of nitrosamines in pharmaceutical drugs please click here.