Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.
Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date
Covering the principles of chromatographic separation, the chromatographic process from a physical chemical perspective, instrumentation for performing analyses, and operational procedures, this second edition offers information needed for the successful practice of gas chromatography. It contains examples of available apparatus, detectors, columns, stationary phases and operating conditions.
Chromatographic Analysis of the Environment, Third Edition is a detailed handbook on different chromatographic analysis techniques and chromatographic data for compounds found in air, water, soil, and sludge. Taking on a new perspective from previous editions, this third edition discusses the parameters of each environmental compartment in a consistent format that highlights preparation techniques, chromatographic separation methods, and detection methods. Most of the data are compiled in tables and figures to elucidate the text as needed. Separate chapters approach specific aspects of sampling methods especially designed for environmental purposes, quantification of environmental analytes in difficult matrices, and data handling. The second part of the book focuses on the analysis of hazardous chemicals in the environment, including volatile organic carbons (VOCs), polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs), and endocrine-disrupting chemicals (EDCs). In addition, the authors feature information on compounds such as phosphates, organic acids, halogenated VOCs, amines, and n-ntirosamines, isocyanates, phthalate esters, and humic substances. Presenting important theoretical and practical aspects from sample collection to laboratory analysis, Chromatographic Analysis of the Environment, Third Edition is a unique resource of chromatographic techniques, data, and references that are useful to all scientists involved in the analysis of environmental compounds.
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.
The powerful, efficient technique of high performance liquid chromatography (HPLC) is essential to the standardization of plant-based drugs, identification of plant material, and creation of new herbal medicines. Filling the void in this critical area, High Performance Liquid Chromatography in Phytochemical Analysis is the first book to give a comp
Chemometrics uses advanced mathematical and statistical algorithms to provide maximum chemical information by analyzing chemical data, and obtain knowledge of chemical systems. Chemometrics significantly extends the possibilities of chromatography and with the technological advances of the personal computer and continuous development of open-source software, many laboratories are interested in incorporating chemometrics into their chromatographic methods. This book is an up-to-date reference that presents the most important information about each area of chemometrics used in chromatography, demonstrating its effective use when applied to a chromatographic separation.
HPLC is the principal separation technique for identification of the pesticides in environmental samples and for quantitative analysis of analytes. At each stage of the HPLC procedure, the chromatographer should possess both the practical and theoretical skills required to perform HPLC experiments correctly and to obtain reliable, repeatable, and r
