Analytical Method Validation
Supporting the control of the physical form of your product
Many drug molecules entering late phase have solubility or dissolution rate limited bioavailability. These attributes are intimately linked to physical form and particle size distribution. Regulatory authorities will require understanding of the processes that influence physical form and particle size and the means with which to monitor them more robustly.
We are proficient in the development and validation of x-ray powder diffraction, thermal analysis and laser diffraction methods in order to support the control of the physical form and particle size distribution of late phase and commercial products.
- Detection or quantification of amorphous content in crystalline material
- Detection or quantification of crystalline content in amorphous material
- Limit tests or quantification of undesired polymorphs, hydrates or solvates in drug substance and drug product
- Batch release against a particle size or physical form specification