Implementation of Impurity Strategy in API Process Development

Development of process for Active Pharmaceutical Ingredient [API] is characterized by variety of aspects that should be considered while choosing the route of synthesis (RoS). Among these aspects are process safety, cost efficiency, ecological considerations, process robustness, and patent restrictions. However, once the RoS is being chosen many efforts are made to achieve the best and the uncompromising quality of API according to the requirements imposed by health authorities.

In our attempt to provide the highest quality API to our patients, we conduct a deep study to understand, identify and control the potential process related impurities formed in the course of synthesis. The implementation of impurity strategy will be illustrated by case studies from the R&D of TEVA’s API division.