Thermal analysis methods for pharmacopoeial materials.

Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) are commonly used for purity and solvent determinations, polymorphism studies and quantitative analysis. These methods are now simple to carry out. Furthermore, automation with robotics allows the use of DSC as a routine control. It is proposed to introduce DSC and TGA in pharmacopoeial monographs as a replacement or alternative to routine melting-point determinations and loss on drying assays. Furthermore, polymorphism and purity may be determined, which is often lacking in monographs. Results of many commercial batches or reference substances of pharmacopoeial raw materials and examples of the use of DSC robotics for quality control are given.