In terms of high product quality, all active ingredients and excipients of a drug must feature high purity. For purity quantification, several analytical methods are available. The small amount of necessary sample material and the fact that the analysis is comparatively fast militate for the use of Differential Scanning Calorimetry (DSC). Provided that the impurity forms a eutectic mixture with the main component, the purity can be derived from the melting behavior using the Van't-Hoff equation.
This webinar covers the following:
- Procedure of calculating the purity in accordance with ASTM E928
- Tips for practical implementation of a Purity Determination by DSC (also by means of an application example)
- Basic information on phase diagrams