Pharmaceutical Impurities - Genotoxins

What is a Genotoxin

Genotoxic substances are those chemical entities which damage DNA causing genetic mutations (mutagens), contributing to the development of cancerous tumors (carcinogens) and can cause birth defects (teratogens). Typical genotoxins, such as aromatic amines, are believed to cause mutations since they are normally electrophilic and form strong covalent bonds with DNA, preventing accurate replication.

As a result of this interaction, it is extremely important to have solid proof that all genotoxins are removed prior to producing the Active Pharmaceutical Ingredient and/or the Drug Product.

The determination of genotoxins in pharmaceuticals is currently attracting the interest of the regulatory authorities, both in Europe and in the United States. Although guidelines have not yet been established, concentrations are generally limited to values in the ppm (ug/g) range, and information in the low ppb (ng/g) is highly desirable.

Atlantic Analytical is well positioned and very capable of developing and validating methods to GLP and GMP standards for low ppb LOQ’s of genotoxins.