GILYOS GmbH

Solid State Characterization of Freeze-Dried Products

Besides 100% visual inspection of the final product (defect mapping) or determination of reconstitution times, GILYOS offers a full range of analytical methods to characterize the solid state product characteristics after freeze-drying.

Modulated Differential Scanning Calorimetry (MDSC) is frequently used to study glass transitions in the product. For crystalline and partially-crystalline systems, a combination of X-Ray Powder Diffractometry and MDSC allows a full quantification of product crystallinity. Moreover, the residual moisture content of freeze-dried products, as determined by Karl-Fischer titration, can be of tremendous importance for API stability. A customer-specific method development for Karl-Fischer (e.g. oven method) is part of our services. Note that it is always recommendable to combine solid state and morphological characterization procedures.