Detecting Nitrosamine content in Pharmaceutical Drugs

The news has recently been full of worldwide 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.

The Ellutia 800 Series TEA is the industry standard for nitrosamine detection thanks to is selectivity and sensitivity for Nitroso compounds. 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 quickly gives an accurate result for the total nitrosamine content of a sample showing both volatile and non-volatile components.  

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 visit