Chemical development: Analytical studies

The analytical techniques used to fully characterize the active pharmaceutical ingredient are very important topics to address. While simple spectroscopic techniques and elemental analyses are sufficient in a medicinal chemistry laboratory, regulatory agencies require a much more elaborate data set to characterize a drug molecule for the registration of a drug. In this chapter, we explore the analytical studies required to validate a test method, test for impurities, to identify the polymorphic structure of the drug, and ensure stability of the drug throughout its life cycle.