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Thin-layer chromatography (TLC) is a powerful, fast and inexpensive analytical method. It has proven its usefulness in pharmaceutical, food and environmental analysis. This new edition of the practical TLC guide features a completely revised chapter on documentation, now including the use of digital cameras. Selected new sorbents and instruments are also introduced. Why has the prior edition been successful? All steps of the analytical procedure are clearly explained, starting with the choice of a suitable TLC technique and ending with data evaluation and documentation. Special emphasis is put on the proper choice of materials for TLC. Properties and functions of various materials and the TLC equipment are described, covering e. g. precoated layers, solvents and developing chambers, including information on suppliers. Many practical hints for trouble shooting are given. All this is illustrated with numerous coloured figures. How to use TLC in compliance with GLP/GMP regulations is described in detail, including the required documentation. Therefore the reader can very easily compile his own standard operating procedures.
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quali...
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screen...
This completely revised and updated fourth edition of the best-selling classic is a thorough treatment of the subject while remaining concise and readable. New additions include capillary electrophoresis, monolithic columns, zwitterion colums, DNA/RNA analysis, fundamentals of the science of IC, and micro methods. The whole is rounded off by handy tables with details on detection or elution conditions, among others.