To understand purity we use NMR, XRPD, DSC, TGA, DVS, FTIR, hot stage and polarised microscopy, aqueous solubility, pH and a simple HPLC analysis. This initial characterisation data provides a benchmark to begin to understand the material “as is” and determine areas where properties, if any, need optimising. It also allows our clients to track the impact of changes to the API. All impurity identification is carried out by our analytical scientists within GMP-controlled laboratories.
At this stage a limited version of our excipient solubility screen can be used to provide an understanding of the extent of solubility of the API in a range of solvents and excipients. This also gives an indication of the possible ways any problems can be resolved.