Over the past decade or so, the issue of the possible presence of DNA-reactive impurities in pharmaceuticals has caused regulators and manufacturers significant problems. This was highlighted by the recall of various products throughout 2019 due to issues with NDMA.
The benefit of using the services of our highly experienced and qualified analysts becomes very apparent when testing for these Genotoxic Impurities due to the low limits of quantitation required to ensure they are not present in products above the acceptable safety limits. These are typically in the region of 1–5ppm, and may be as low as 1-5ppb, as in the case of NDMA.
Our experience of testing for metal impurities, some of which can also cause DNA mutations, makes us your perfect analytical partner to help ensure the safety of your pharmaceutical products.
Explore some of the techniques we commonly use for the testing for genotoxic impurities:
