In recent years, the news has seen numerous high profile product recalls of various pharmaceutical drugs containing nitrosamines. Nitrosamines are carcinogenic compounds and therefore should be monitored to ensure that unsafe levels are not found in consumer products. Governments around the world are now requiring reports on nitrosamine levels. Manufacturers often find testing anything but straightforward, with common problems including reaching required detection limits and false positives.
The Ellutia tea 800 series is the ideal detector for the analysis of nitrosamines thanks to its selectivity and sensitivity for nitroso compounds. The TEA is a chemiluminescence detector that can be interfaced to a GC, HPLC or total nitrosamine analysis system. In GC operation, the TEA operates by using a pyrolyzer to cleave the NO group of 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 pharmaceutical drugs, the 800 TEA series can be interfaced with a chemical stripping system that allows rapid testing of N-Nitrosamine (Apparent Total Content of N-nitrosamine). This uses a chemical reaction to remove the NO group rather than a pyrolyzer. 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 analyzed by an 800 series TEA interfaced to a GC where volatile nitrosamines such as NDMA (N-nitrosodimethylamine) can be separated and quantified.
For more information on how the TEA Ellutia 800 Series can aid in the detection of nitrosamines in pharmaceutical drugs, please Click here.