Identification and Determination of Impurities in Drugs
Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis.
Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book.
The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.
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Chapter 2 Indenification structure elucidation and determination of related organic impurities
Chapter 3 Identification and determination of residual solvents
Chapter 4 Identification semiquantitative and quantitative determination of inorganic impurities
Chapter 5 Degradation products as impurities
Chapter 6 Determination of enantiomeric impurities
طبعات أخرى - عرض جميع المقتطفات
acetate acetonitrile acid Anal analytical application Biomed buffer bulk drug capillary capillary electrophoresis Chem chemical chiral Chromatogr chromatographic column compounds containing degradation products derivatisation derivatives detection determination dif®cult diode-array drug material drug substance ef®ciency electrophoresis eluent elution enantiomeric purity enantiomers European Pharmacopoeia example Figure gas chromatography Gazdag Gedeon Richter Ltd GoÈroÈg HPLC HPLC method HPLC/MS HPLC/NMR identi®cation impurity pro®ling in¯uence injection Intentionally Left Blank ionisation limit lisinopril main component mass mass spectrometry measured methanol metoprolol mixture ml/min mobile phase modi®cation molecular molecules norgestrel obtained optimisation ow rate peak peptide Pharm pipecuronium bromide planar protein purity test quantitative re¯ection reaction reagent residual solvents Reson sample Section selectivity sensitivity separation signal silica sodium solution solvents speci®c spectra spectrometry spectroscopy spectrum stationary phase steroids structure elucidation studies suf®cient suitable synthesis techniques temperature tion validation volatile