- Author(s):
- Organization(s):
Adroit Science AB Emmace Consulting AB Sandoz
Applied to typical DPI formulations, the methodology enables detection of polymorph impurities at levels comparable to, or better than, corresponding determinations using conventional synchrotron radiation.
The method has the capacity to run multiple samples per day and is therefore highly suitable for routine support during formulation and process optimization and in stability studies. A critical factor for success, however, is that it must be performed in a laboratory that has the ability to control the relative humidity.