Handbook Of Modern Pharmaceutical Analysis

Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080488929
Size: 17.97 MB
Format: PDF
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This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Handbook Of Pharmaceutical Analysis By Hplc

Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080455181
Size: 65.96 MB
Format: PDF, ePub, Mobi
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High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 008050776X
Size: 38.39 MB
Format: PDF, ePub
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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-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Pharmaceutical Analysis For Small Molecules

Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119425034
Size: 10.83 MB
Format: PDF, Kindle
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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Handbook Of Methods And Instrumentation In Separation Science

Author:
Publisher: Academic Press
ISBN: 9780123757272
Size: 59.86 MB
Format: PDF, ePub
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Handbook of Methods and Instrumentation in Separation Science, Volume 1 provides concise overviews and summaries of the main methods used for separation. It is based on the Encyclopedia of Separation Science. The handbook focuses on the principles of methods and instrumentation. It provides general concepts concerning the subject matter; it does not present specific procedures. This volume discusses the separation processes including affinity methods, analytical ultracentrifugation, centrifugation, chromatography, and use of decanter centrifuge and dye. Each methodology is defined and compared with other separation processes. It also provides specific techniques, principles, and theories concerning each process. Furthermore, the handbook presents the applications, benefits, and validation of the processes described in this book. This handbook is an excellent reference for biomedical researchers, environmental and production chemists, flavor and fragrance technologists, food and beverage technologists, academic and industrial librarians, and nuclear researchers. Students and novices will also find this handbook useful for practice and learning. One-stop source for information on separation methods General overviews for quick orientation Ease of use for finding results fast Expert coverage of major separation methods Coverage of techniques for all sizes of samples, pico-level to kilo-level

Handbook Of Affinity Chromatography Second Edition

Author: David S. Hage
Publisher: CRC Press
ISBN: 9780824751982
Size: 21.67 MB
Format: PDF
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This essential handbook guides investigators in the theory, applications, and practical use of affinity chromatography in a variety of fields including biotechnology, biochemistry, molecular biology, analytical chemistry, proteomics, pharmaceutical science, environmental analysis, and clinical chemistry. The Handbook of Affinity Chromatography reflects upon important factors to consider in the development of affinity methods, such as the choice of support material, immobilization methods, and application or elution conditions. It reviews common affinity methods and explores the latest preparative, analytical, and biophysical applications, including the use of affinity chromatography with other separation techniques and analytical systems. This basis seamlessly supports the discussion of recent developments in techniques including the use of affinity ligands in capillary electrophoresis, mass spectrometry, microanalytical systems, and optical biosensors. New chapters feature expanded discussions on molecularly imprinted polymers and biomimetic ligands, chromatographic immunoassays, affinity-based immunoassays, affinity-based chiral stationary phases, and affinity ligands in multidimensional systems. Engaging the collaboration of 48 scientists and students from 23 laboratories and organizations to present the latest information on affinity methods, the Handbook of Affinity Chromatography illustrates a wide range of applications and theory for scientists, students, and laboratory workers throughout the fields of chemistry and biology.

Handbook Of Membrane Separations

Author: Anil K. Pabby
Publisher: CRC Press
ISBN: 0849395496
Size: 13.23 MB
Format: PDF
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The Handbook of Membrane Separations: Chemical, Pharmaceutical, and Biotechnological Applications provides detailed information on membrane separation technologies as they have evolved over the past decades. To provide a basic understanding of membrane technology, this book documents the developments dealing with these technologies. It explores chemical, pharmaceutical, food processing and biotechnological applications of membrane processes ranging from selective separation to solvent and material recovery. This text also presents in-depth knowledge of membrane separation mechanisms, transport models, membrane permeability computations, membrane types and modules, as well as membrane reactors.

Modern Hplc For Practicing Scientists

Author: Michael W. Dong
Publisher: John Wiley & Sons
ISBN: 111929360X
Size: 48.59 MB
Format: PDF, ePub, Mobi
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A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.