Mechanical stresses during processing may introduce small amounts of amorphous material which can have a relevant effect on the products properties, including solubility and stability. Crysforma applies several available analytical techniques (PXRD, thermal analysis, DVS) to determine small amounts of amorphous phase in a crystalline solid.
Solid form hygroscopicity and stability
Use of dynamic vapour sorption analysis (DVS) and climatic chambers to determine the effects of relative humidity and temperature on the solid form of interest.
Particle Size Distribution
A very important characteristic of a solid to understand its physical and chemical properties is the particle size. The particle size distribution of an API can be crucial in order to have the required solubility parameters within the specification of the product. Therefore a standardized analysis is needed in order to determine the PSD of a production batch. Crysforma develops analysis methods and performs the analyses of samples using a laser diffraction methodology (wet dispersion).
Physisorption gas analysis: Surface Area and Porosity Measurement (BET analysis)
The specific surface area and the porosity are important parameters for the characterization of solids. The physical and chemical behaviour of solids can be studied and directly correlated to the pore size and distribution of the material. BET analysis provides this information by evaluating the nitrogen or helium gas adsorbed at the surface of the solid.