Various Aspects of the Estimation of Impurities in Drugs. Introductory remarks (S. Görög). The nature and origin of the impurities in drug substances (S. Görög). Toxicological aspects (R. Lee). The role of impurity profiling in drug research, development and production (S. Görög). Regulatory aspects. ICH and pharmacopeial perspectives (J.P. Boehlert).
Identification, Structure Elucidation and Determination of Related Organic Impurities. Strategies in impurity profiling (S. Görög). UV-VIS spectroscopy and fluorimetry (S. Görög). Mass spectrometry in impurity profiling (M. Mák et al.). NMR spectroscopy (Cs. Szántay Jr., Á. Demeter). Planar chromatography (K. Ferenczi-Fodor, Z. Végh). Gas chromatography (GC) and related techniques (A. Laukó). High-performance liquid chromatography (HPLC) and related techniques (M. Gazdag). Determination of drug related impurities by capillary electrophoresis (K.D. Altria). Capillary electrochromatography (CEC) (M.R. Euerby). CEC/MS (S.L. Lane). Supercritical fluid chromatography (SFC) (O. Gyllenhaall). Purity check by differential scanning calorimetry (I. Péter).
Identification and Determination of Residual Solvents. Thermoanalytical methods (I. Péter). Gas chromatography and GC/MS (J. Bertram). NMR spectroscopy (G. Balogh). Miscellaneous (S, Görög).
Identification, Semiquantitative and Quantitative Determination of Inorganic Impurities. Classical methods (S. Görög). Atomic spectroscopy (A. Lásztity). Other methods (S. Görög).
Degradation Products as Impurities (S. Görög). The relation between drug stability studies and the estimation of impurity profiles. Aims, forms and conditions of drug stability testing.