Purity Analysis of Pharmaceuticals by DSC according to ASTM E928-19
The purity of pharmaceutical compounds is a critical parameter influencing product quality and regulatory compliance. Differential Scanning Calorimetry (DSC) enables fast and reliable purity determination based on melting behavior. This application report demonstrates the determination of phenacetin purity according to ASTM E928-19 using a certified reference material (NIST SRM 1514) containing defined impurity levels of p-aminobenzoic acid.
The purity of crystalline pharmaceutical compounds is a key quality attribute that directly affects stability, efficiency, and safety. Reliable and efficient methods for purity determination are therefore essential in pharmaceutical development, production, and quality control. Differential Scanning Calorimetry (DSC) provides a rapid and solvent-free approach for purity analysis by evaluating melting behavior. According to ASTM E928-19, impurities cause depression of the melting temperature and broadening of the melting peak. By applying the van’t Hoff relationship to the melting curve, the impurity content and purity of the main component can be quantitatively determined.
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