Services I Services & Capabilities
Analytical development is not only confined to methods that determine structure and purity but also associated impurities that may be present.
These could include related impurities formed during a synthesis or residual impurities from materials used. e.g. solvents or metals from catalysts.
We carry out a risk assessment of the total process to determine the impurities that may be present and the associated impact that may have on your target material. This enables specifications of intermediates/final products to be defined and in turn the analytical methods that will be required.
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.