Charaterisation of the impurity profile of drug substances: a combined chromatographic on chemometric approach.

The characterisation of impurities in a new drug substance is important because of the protection of the patient against unwanted side effects. All substances that occur as impurities in a pharmaceutical substance with a concentration of more than 0,1 or 0,05% must be characterized. This concerns substances that orginate during synthesis, purification or storage. In the early stages of the investigation of a new drug substance, one does not know the impurities. the project aims at developing an optimal generic battery of chromatographic methods combined with chemomtric peak purity techniques and a strategy that allows to automatically treat the data to define the impurity profile. The project consists of three parts, namely: - the further development of chemometric peak purity techniques, - the development of a generic battery of orthogonal chromatographic methods and its validation. - the development of an expert system that allows to combine and translate the information from the different chromatogram and peak purity tests into an impurity profiel.