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Comparison of high sensitivity micro differential scanning calorimetry with X-ray powder diffractometry and FTIR spectroscopy for the characterization of pharmaceutically relevant non-crystalline materials
M. Song 1, W. Liebenberg 2, M. M. de Villiers 1, M. M. de Villiers 3
Affiliations
Article Info
1 Department of Basis Pharmaceutical Sciences, School of Pharmacy, Universität of Louisiana at Monroe, Monroe, LA 71209, USA
2 Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, 2520, South Africa
3 School of Pharmacy, University of Wisconsin, 777 Highland Avenue, Madison, WI 53705-2222, USA,
Abstract
In this study, high sensitivity micro differential scanning calorimetry (MDSC) in the scanning of dynamic mode was compared to X-ray powder diffractometry (XRPD) for quantifying amorphous nifedipine in mixtures crystalline nifedipine. This technique was also compared with FTIR for quantifying polymorph A of chloramphenicol palmitate (CAP) and poly DL-lactide-co-glycolide) (PLGA) in pharmaceutical formulations. The limit of determination (LOD) achieved by MDSC were 0.06% compared to 5% for XRPD quantification of amorphous nifedipine and 0.02% compared to 7% for IR quanitfication of polymorph A of CAP. As little as 0.165 mg PLGA could be measured in excipients mixtures. Desirable linearity and repeatability were established in all cases.