Targeted nitrosamine testing: how are the challenges being addressed?
Ellutia (Cambridge, UK) have developed an automated total nitrosamine analyzer, which enables a non-targeted approach to nitrosamine testing. The technology utilizes the 800 Series Thermal Energy Analyzer, allowing users to identify volatile and non-volatile nitrosamine content at levels down to 1 ppb. The system targets the nitrosamine functional group, meaning that individual standards for all nitrosamines present are not required to detect them.
Nitrosamines are a class of mutagenic impurities, which contain the nitroso functional group and can present themselves in complex forms. There are 27 known nitrosamines and each has a different permissible daily intake level, which is highly regulated.
As potential human carcinogens, it is important that the pharmaceutical industry has specific and sensitive techniques to identify and quantify them. The industry has faced key challenges in detecting and testing for nitrosamines including, time-consuming chromatographic techniques, high equipment costs and staff personnel training costs.
It is hoped that this non-targeted approach will allow users to quickly screen samples and only pass positive samples on for more speciated nitrosamine analysis. The team believes that non-targeted testing offers a pragmatic approach to screening nitrosamines in raw materials and finished products.
