Quantitation of Crystalline and Amorphous Solid Dispersion
Detecting and quantifying the presence of amorphous phase in API or drug product samples is often quite challenging, but absolutely critical to understanding any possible risks of chemical instability and/or variability in dissolution or solubility. Crystal Pharmatech utilizes cutting edge thermal analysis techniques combined with XRPD and ssNMR (often times nuclei other than 13C) to detect and quantitate the presence of amorphous material in either API or drug product.