Appraisal of thermal methods used in the analysis of API and Pharmaceutical Raw Materials

Abstract

This review provides an overview of the application of thermal analysis techniques in the characterization of Active Pharmaceutical Ingredients (APIs) and pharmaceutical raw materials. Thermal analysis, encompassing methods such as Differential Scanning Calorimetry (DSC), Differential Thermal Analysis (DTA), Thermogravimetric Analysis (TGA), Thermomechanical Analysis (TMA), Dynamic Mechanical Analysis (DMA), Thermo-microscopy or Hot Stage Microscopy (HSM), Melting Point (MP), plays a crucial role in understanding the physicochemical properties, stability, and compatibility of these materials. These techniques offer valuable insights into various thermal events, including melting points, glass transition temperatures, crystallization, decomposition, and polymorphism. By precisely measuring changes in heat flow, mass, and other thermal properties as a function of temperature or time, researchers can assess the purity, identify different solid forms, determine moisture content, and evaluate the thermal stability of APIs and excipients. Furthermore, thermal analysis is instrumental in pre-formulation studies for predicting drug-excipient interactions, optimizing manufacturing processes, and ensuring the overall quality and shelf-life of pharmaceutical products. The data obtained from thermal analysis is essential for regulatory submissions and for establishing robust quality control parameters throughout the drug development lifecycle.