Development work in phase III focuses on designing defined physicochemical parameters for the API. Emphasis is on investigating polymorphism and salt formation, as well as studying the morphology, formation and control of the crystals. The control of particle size and solubility of the crystals as a function of particle dimensions are also studied.

Another aspect of development at this stage is route optimization of the synthetic process through re-designing and fine tuning. During this process, critical parameters, such as robustness of the process, reproducibility of the impurity profile, unit operations, ecology and cost effectiveness are taken into consideration. For this evaluation, statistical methods are used, like MODDE, DoE and others.

Calorimetric measurements are carried out with an RC1-equipment, and a Lasentec apparatus is used for studying nucleation and crystallization phenomena. Other analytical instruments include a 400 MHz NMR, X-ray, FT-IR, TGA, GC-MS in addition to LC-MS equipment.