Impurities should be reported at levels in excess of the 0.03 – 0.05% (300 – 500 ppm, by weight) range according to ICH_Q3A_R2 guidelines. Genotoxic impurities, or potentially genotoxic impurities, must be controlled at levels significantly lower than this. Typically, developing limit tests of less than 50 ppm for highly toxic impurities is readily achievable. However it can be difficult to develop a test to control a particular genotoxic impurity at the current EMEA guideline limit of 1.5 ppm (0.00015% w/w) or less.

Our goal is to identify and quantify known and potential genotoxic impurities early in development, and to test for these impurities in the intermediates with the final goal of demonstrating that the manufacturing process controls them, by consuming or eliminating them, before reaching the final drug substance.

By combining improved synthetic routes along with specific and highly sensitive analytical technology, genotoxic impurities can be drastically minimized, if not eliminated, in the final active pharmaceutical ingredient and drug product.

At a minimum, synthetic reagents and final product impurities that have functional groups associated with genotoxic potential need to be further analyzed by an Ames or Micronucleus Test. We offer you assistance in this area. As partners we offer you seamless genotoxin testing, from both our chemical and our partner’s biological perspective.

Our methods can be developed for early Phase I and Phase II work, and they can also be developed with full validation according to cGMP for Phase III needs.