HFR has experience in the development of analytical methods suitable for assay and related impurities, and the subsequent validation of these methods.
Before commencing GMP manufacture, it is also necessary to carry out full validation of key analytical methods to ICH standards. Since the analytical method is likely to be used for stability testing and stress testing work, i.e. deliberate degradation of API under a variety of conditions e.g. heat, acid, base, oxidation and light, this is an essential exercise.