We conduct research on the stability of starting materials and finished products in a fast-track, long-term and indirect conditions according to ICH Q1A (R2) guidelines along with full physicochemical analysis using validated methods in accordance with the suggested specification.

It is possible to conduct stability testing in different conditions based on additional arrangements (e.g. conditions of specific climate chamber).

Initial stability and chemical compatibility of the formulation is tested using differential scanning calorimetry (micro-DSC) in isothermal experiments and the use of dynamic scanning. We are able to observe the minimum reaction energy using isothermal titration calorimetry (ITC).