ELŻBIETA U. STOLARCZYK, ANDRZEJ KUTNER
NOWE STRATEGIE W BADANIU PROFILU ZANIECZYSZCZEŃ
Novel strategies in the impurity profiles investigation of pharmaceutical substances. The European Medicines Agency, The United States Foods and Drug Administration, and other drug regulation authorities are involved in purity guidelines and impurity identification in the pharmaceutical substances according to the new regulations of the International Conference on Harmonization (ICH). At present, the concept of the purity profile study is gradually replaced with the one of the impurity profile study. Determination of the source of impurities, as well as their analysis and control are critical in the production of high quality APIs. In this work it is discussed the aim and role of the determination of impurity profile in respect to the drug safety. A general outline of new strategies in the preparation of the impurity profile of APIs is also presented. Different methodological aspects are described with particular emphasis on chromatography, mass spectrometry and combination of both techniques.