Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a larege number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.
Hardbound. In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.Features of this book:
• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry
• Illustrates the different approaches available to attain robustness
If you are a researcher in organic chemistry, chemical engineering, pharmaceutical science, forensics, or environmental science, you make routine use of chemical analysis. And like its best-selling predecessor was, the Handbook of Basic Tables for Chemical Analysis, Second Edition is your one-stop source for the information needed to design chemical analyses. Here's what is new in the Second Edition:"New chapters on solutions, electroanalytical methods, electrophoresis, and laboratory safety"An expanded section on gas chromatography that includes data on compounds that attack common detectors"New information on detector optimization"An updated section on high performance liquid chromatography that provides the most recent chiral stationary phases, detector information, and revised solvent tables"Updated information on the most useful "wet" chemistry methods"Enlarged section of Miscellaneous Tables Going far beyond the landmark first edition in terms of scope and applications, the second edition provides current and updated data culled from a wide range of resources and consolidated into a concise yet easy-to-use format. The book's laser-like focus on core information gives you the knowledge you need when you need it - at the decision point.
Monitoring pollutants in air, soil and water is a routine requirement in the workplace, and in the wider environment. Passive samplers can provide a representative picture of levels of pollutants over a period of time from days to months by measuring the average concentrations to which they have been exposed. Air monitors are widely used, for instance to measure the exposure of workers to volatile compounds, but also for monitoring the fate of pollutants in the atmosphere. Passive sampling devices are now becomining increasingly used to monitor pollutants in rivers, coastal waters and ground water where contamination results from sources such as domestic and industrial discharges, and the use of agrochemicals.
Instant Notes in Analytical Chemistry provides concise yet comprehensive coverage of analytical chemistry at an undergraduate level, providing easy access to the core information in the field. The book covers all the important areas of analytical chemistry in a format which is ideal for learning and rapid revision.