The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products.
SAXOCON can assist with the qualification of these impurities and provide recommendations for the assignment of finished product specifications. Issues associated with impurities may arise as a result of the reformulation of existing drug products, changes in the manufacture and supply of raw material ingredients. Issues with impurities may also be due alternative methods and routes of ingredient synthesis, or other changes to the Chemistry, Manufacturing and Controls which result in a different impurity profile. We are experienced in toxicological profiling and evaluation of synthetic impurities, degradation products, residual solvents and elemental impurities to ensure the safety and quality of drug products. This includes read-across evaluation of repeated-dose toxicity of impurities based on short-term and long-term in vivo studies for structurally similar chemicals, as a key component to such analysis.