How DSC and TGA Support Compatibility Assessment of APIs
Finished pharmaceutical products usually consist of many ingredients, namely the API and several excipients. The excipients assume different functions, e.g., as processing aids, as stabilizers or as release-controlling agents. In any case, the individual components should not negatively influence each other, so that efficacy and stability of the API are always maintained. This needs already to be worked out during formulation development as described in ICH Q8(R2).
Thermal Analysis, and here especially DSC (Differential Scanning Calorimetry) and TGA (Thermogravimetric Analysis), are widely used for such compatibility studies. Their advantages are fast processing possibilities as well as the need for only small sample masses.
In this webinar, learn more about the methods mentioned, how they are applied and what conclusions can be drawn from the measurement results and ultimately benefit from the opportunities available to you.
