ABSTRACT

A great number of characterization methodologies can be employed during the preformulation stage of drug development, and each has its associated utility and function for the physical characterization of a drug substance. However, when a large amount of information is to be gleaned from a small amount of sample, spectroscopic methods of analysis can be of the greatest use. Most of the methods are nondestructive in nature, and the analyzed material can be recycled for additional study once the measurements are complete. Of particular importance during the preformulation program is the study of crystal forms of the drug substance, and spectroscopic techniques can prove to be valuable adjuncts to the standard range of crystallographic procedures.