Hplc Method Development For Pharmaceuticals

Autor: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080554199
File Size: 17,42 MB
Format: PDF, Docs
Read: 1995
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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Handbook Of Pharmaceutical Analysis By Hplc

Autor: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080455181
File Size: 48,65 MB
Format: PDF, ePub
Read: 7754
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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 Modern Pharmaceutical Analysis

Autor: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780123759818
File Size: 75,28 MB
Format: PDF, ePub, Docs
Read: 4540
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Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Capillary Electrophoresis Methods For Pharmaceutical Analysis

Autor: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080559612
File Size: 39,15 MB
Format: PDF, Mobi
Read: 6581
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Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control. - Provides current status and future developments in CE analysis of pharmaceuticals. - Explains how to develop and validate methods. - Includes major pharmaceutical applications including assays and impurity testing.

Hplc For Pharmaceutical Scientists

Autor: Yuri V. Kazakevich
Publisher: John Wiley & Sons
ISBN: 0470087943
File Size: 48,48 MB
Format: PDF
Read: 8188
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HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

Autor: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780120449828
File Size: 10,61 MB
Format: PDF, Mobi
Read: 6355
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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.

Introduction To Modern Liquid Chromatography

Autor: Lloyd R. Snyder
Publisher: John Wiley & Sons
ISBN: 1118210395
File Size: 51,36 MB
Format: PDF, ePub, Docs
Read: 9803
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The latest edition of the authoritative reference to HPLC High-performance liquid chromatography (HPLC) is today the leading technique for chemical analysis and related applications, with an ability to separate, analyze, and/or purify virtually any sample. Snyder and Kirkland's Introduction to Modern Liquid Chromatography has long represented the premier reference to HPLC. This Third Edition, with John Dolan as added coauthor, addresses important improvements in columns and equipment, as well as major advances in our understanding of HPLC separation, our ability to solve problems that were troublesome in the past, and the application of HPLC for new kinds of samples. This carefully considered Third Edition maintains the strengths of the previous edition while significantly modifying its organization in light of recent research and experience. The text begins by introducing the reader to HPLC, its use in relation to other modern separation techniques, and its history, then leads into such specific topics as: The basis of HPLC separation and the general effects of different experimental conditions Equipment and detection The column—the "heart" of the HPLC system Reversed-phase separation, normal-phase chromatography, gradient elution, two-dimensional separation, and other techniques Computer simulation, qualitative and quantitative analysis, and method validation and quality control The separation of large molecules, including both biological and synthetic polymers Chiral separations, preparative separations, and sample preparation Systematic development of HPLC separations—new to this edition Troubleshooting tricks, techniques, and case studies for both equipment and chromatograms Designed to fulfill the needs of the full range of HPLC users, from novices to experts, Introduction to Modern Liquid Chromatography, Third Edition offers the most up-to-date, comprehensive, and accessible survey of HPLC methods and applications available.

Capillary Electrophoresis Methods For Pharmaceutical Analysis

Autor: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080559612
File Size: 67,46 MB
Format: PDF
Read: 6971
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Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control. - Provides current status and future developments in CE analysis of pharmaceuticals. - Explains how to develop and validate methods. - Includes major pharmaceutical applications including assays and impurity testing.

Chromatography And Separation Science

Autor: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780120449811
File Size: 75,84 MB
Format: PDF
Read: 6716
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The basic objectives of this book are to: provide basic information on chromatography and separation science; show how simple extraction and partition processes provide the basis for development of chromatography and separation science; describe the role of chromatography and separation science in various fields; discuss the role of chromatography and separation science in development of new methodology; and present new evolving methods and how to select an optimum method. · The book covers the fundamental physical and chemical phenomena involved in separations · Provides a concise overview of the basics of transport phenomena and thermodynamics · Shows the importance of chromatography within separation science

Introduction To Pharmaceutical Chemical Analysis

Autor: Steen Honor? Hansen
Publisher: John Wiley & Sons
ISBN: 1119954339
File Size: 64,10 MB
Format: PDF, Docs
Read: 3079
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This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples