HANDBOOK OF MODERN PHARMACEUTICAL ANALYSIS

Today, modern pharmaceutical analysis entails much more than the analysis of active pharmaceutical ingredients or the formulated product. There are many reasons for this change, not the least of which is our ability to better understand physicochemical properties of pharmaceutical compounds through the use of advanced instrumental methods. Furthermore, there is a need for quality assurance of pharmaceutical products throughout their shelf life. This requires that we study interactions of the drug substance with the excipients in the presence of residual solvents, as well as other potential degradation reactions that may occur in the formulated product over a period of time under various stress conditions (these include conditions they may be subjected to during storage or shipment in the final package configuration.