Summary For any generic pharmaceutical developer submitting a new drug application, the process of demonstrating the equivalence of a topical pharmaceutical to a reference listed drug can be a grueling process. Not least of the challenges facing regulatory affairs personnel is navigating the often-daunting landscape of rheological measurements. Agencies such as the FDA and EMA…
Thermal Analysis in the Pharmaceutical Industry: Use of TGA, SA, and DSC in Research, Development, and Quality Control
Part 3: Detecting Drug-Excipient Incompatibility
DSC Characterization of Crystalline Structure in Foods and Pharmaceuticals: Apparent Melting Part 2 Overview This webinar on “Apparent Melting” is part two of a three-part series on use of Differential Scanning Calorimetry to characterize crystalline structure of foods and pharmaceuticals. Although apparent melting looks like true/thermodynamic melting and causes a loss of crystalline structure,…
DSC Characterization of Crystalline Structure in Foods and Pharmaceuticals Part 1 Overview The determination of the crystalline structure that exists in a pharmaceutical material is critical to fully understanding the inherent properties of the resultant drug. The crystal structure can influence the drug’s properties, such as stability and dissolution rates, as well as impact the…
Kadine Mohomed – Characterization of Amorphous Pharmaceuticals by DSC Analysis The glass transition temperature of an amorphous pharmaceutical solid is a critical physical property that can greatly influence the material’s chemical stability, physical stability, and viscoelastic properties. Thankfully with specific analytical tests made possible through the use of Differential Scanning Calorimetry, this and other thermal…