ABSTRACT

The laboratory is a vital link in the development, manufacture, and marketing of today's pharmaceutical products. In discovery and formulation development, the lab strives to learn and record everything about the new chemical entity. Lab analysts must fully characterize active ingredients, assess the viability of formu­ lations, isolate and identify impurities and degradation products, document sta­ bility and solubility profiles, and begin to develop the various methodologies that can open the door to the chemical's potential use as a new pharmaceutical.