ABSTRACT

Process chemists are responsible for preparing multikilogram quantities of drug candidates to support toxicological studies, formulation development, and clinical trials and to design practical, efficient, environmentally benign, and economically viable commercial processes for approved products. Acceleration of the development time line for the discovery and development of new pharmaceutical agents and the requirement for reproducible and validated manufacturing processes in the pharmaceutical industry have led to an increased application of process analytics for realtime monitoring of chemical processes. One of the most versatile technologies in this area is midinfrared (IR) owing to its specificity and adaptability to manufacturing environments.