Table of Contents
- 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. Elucidation of degradation pathways. Elucidation of light-induced degradation pathways. Methodological aspects of quantitative drug stability studies based on degradates.
Determination of Enantiomeric Impurities. Introduction (S. Görög). Chromatographic methods (S. Görög). Capillary electrophoretic (CE) methods (J. Crommen). Polarimetry, ORD and CD spectroscopy (A. Gergely). NMR spectroscopy (G. Tárkányi).
Estimation of Polymorphic Modifications as Impurities in Drugs. The phenomenon and importance of polymorphism (B. Hegedüs). Infrared and Raman spectroscopy (B. Hegedüs). Thermoanalytical methods (I. Péter). X-ray crystallography (M. Bálint).
Microbiological Examination of Non-Sterile Drugs and Raw Materials (H. Van Doorne). Introductory remarks. Validation. Total viable count. Tests for specified organisms. Concluding remarks.
Selected Examples (Impurity Profiling of Some Groups of Drugs). Peptides (S. Görög). Biotechnological products (K. Ganzler, A.S. Cohen). Antibiotics (A. Van Schepdael et al.). Steroids (S. Görög). Subject Index.
- No. of pages: 772
- Language: English
- Copyright: © Elsevier Science 2000
- Published: May 1, 2000
- Imprint: Elsevier Science
- eBook ISBN: 9780080534404
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