HPLC and UHPLC for Practicing Scientists

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Publisher : John Wiley & Sons
ISBN 13 : 1119313767
Total Pages : 410 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis HPLC and UHPLC for Practicing Scientists by : Michael W. Dong

Download or read book HPLC and UHPLC for Practicing Scientists written by Michael W. Dong and published by John Wiley & Sons. This book was released on 2019-07-23 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise yet comprehensive reference guide on HPLC/UHPLC that focuses on its fundamentals, latest developments, and best practices in the pharmaceutical and biotechnology industries Written for practitioners by an expert practitioner, this new edition of HPLC and UHPLC for Practicing Scientists adds numerous updates to its coverage of high-performance liquid chromatography, including comprehensive information on UHPLC (ultra-high-pressure liquid chromatography) and the continuing migration of HPLC to UHPLC, the modern standard platform. In addition to introducing readers to HPLC’s fundamentals, applications, and developments, the book describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. HPLC and UHPLC for Practicing Scientists, Second Edition offers three new chapters. One is a standalone chapter on UHPLC, covering concepts, benefits, practices, and potential issues. Another examines liquid chromatography/mass spectrometry (LC/MS). The third reviews at the analysis of recombinant biologics, particularly monoclonal antibodies (mAbs), used as therapeutics. While all chapters are revised in the new edition, five chapters are essentially rewritten (HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects). The book also includes problem and answer sections at the end of each chapter. Overviews fundamentals of HPLC to UHPLC, including theories, columns, and instruments with an abundance of tables, figures, and key references Features brand new chapters on UHPLC, LC/MS, and analysis of recombinant biologics Presents updated information on the best practices in method development, validation, operation, troubleshooting, and maintaining regulatory compliance for both HPLC and UHPLC Contains major revisions to all chapters of the first edition and substantial rewrites of chapters on HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects Includes end-of-chapter quizzes as assessment and learning aids Offers a reference guide to graduate students and practicing scientists in pharmaceutical, biotechnology, and other industries Filled with intuitive explanations, case studies, and clear figures, HPLC and UHPLC for Practicing Scientists, Second Edition is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology. It will be a great benefit to every busy laboratory analyst and researcher.

Modern HPLC for Practicing Scientists

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111929360X
Total Pages : 285 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Modern HPLC for Practicing Scientists by : Michael W. Dong

Download or read book Modern HPLC for Practicing Scientists written by Michael W. Dong and published by John Wiley & Sons. This book was released on 2016-04-06 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Modern HPLC for Practicing Scientists

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Author :
Publisher : Wiley-Interscience
ISBN 13 : 9780471727897
Total Pages : 304 pages
Book Rating : 4.7/5 (278 download)

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Book Synopsis Modern HPLC for Practicing Scientists by : Michael W. Dong

Download or read book Modern HPLC for Practicing Scientists written by Michael W. Dong and published by Wiley-Interscience. This book was released on 2006-06-12 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical HPLC Method Development

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118591518
Total Pages : 665 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Practical HPLC Method Development by : Lloyd R. Snyder

Download or read book Practical HPLC Method Development written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2012-12-03 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revision brings the reader completely up to date on the evolving methods associated with increasingly more complex sample types analyzed using high-performance liquid chromatography, or HPLC. The book also incorporates updated discussions of many of the fundamental components of HPLC systems and practical issues associated with the use of this analytical method. This edition includes new or expanded treatments of sample preparation, computer assisted method development, as well as biochemical samples, and chiral separations.

Introduction to Modern Liquid Chromatography

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Publisher : John Wiley & Sons
ISBN 13 : 1118210395
Total Pages : 831 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Introduction to Modern Liquid Chromatography by : Lloyd R. Snyder

Download or read book Introduction to Modern Liquid Chromatography written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 831 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

HPLC for Pharmaceutical Scientists

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Publisher : John Wiley & Sons
ISBN 13 : 0470087943
Total Pages : 1136 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis HPLC for Pharmaceutical Scientists by : Yuri V. Kazakevich

Download or read book HPLC for Pharmaceutical Scientists written by Yuri V. Kazakevich and published by John Wiley & Sons. This book was released on 2007-02-16 with total page 1136 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ultra-High Performance Liquid Chromatography and Its Applications

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Publisher : John Wiley & Sons
ISBN 13 : 1118533984
Total Pages : 342 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Ultra-High Performance Liquid Chromatography and Its Applications by : Q. Alan Xu

Download or read book Ultra-High Performance Liquid Chromatography and Its Applications written by Q. Alan Xu and published by John Wiley & Sons. This book was released on 2013-04-01 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explores both the benefits and limitations of new UHPLC technology High performance liquid chromatography (HPLC) has been widely used in analytical chemistry and biochemistry to separate, identify, and quantify compounds for decades. The science of liquid chromatography, however, was revolutionized a few years ago with the advent of ultra-high performance liquid chromatography (UHPLC), which made it possible for researchers to analyze sample compounds with greater speed, resolution, and sensitivity. Ultra-High Performance Liquid Chromatography and Its Applications enables readers to maximize the performance of UHPLC as well as develop UHPLC methods tailored to their particular research needs. Readers familiar with HPLC methods will learn how to transfer these methods to a UHPLC platform and vice versa. In addition, the book explores a variety of UHPLC applications designed to support research in such fields as pharmaceuticals, food safety, clinical medicine, and environmental science. The book begins with discussions of UHPLC method development and method transfer between HPLC and UHPLC platforms. It then examines practical aspects of UHPLC. Next, the book covers: Coupling UHPLC with mass spectrometry Potential of shell particles in fast liquid chromatography Determination of abused drugs in human biological matrices Analyses of isoflavones and flavonoids Therapeutic protein characterization Analysis of illicit drugs The final chapter of the book explores the use of UHPLC in drug metabolism and pharmacokinetics studies for traditional Chinese medicine. With its frank discussions of UHPLC's benefits and limitations, Ultra-High Performance Liquid Chromatography and Its Applications equips analytical scientists with the skills and knowledge needed to take full advantage of this new separation technology.

Mass Spectrometry

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Publisher : John Wiley & Sons
ISBN 13 : 1118681940
Total Pages : 502 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Mass Spectrometry by : Edmond de Hoffmann

Download or read book Mass Spectrometry written by Edmond de Hoffmann and published by John Wiley & Sons. This book was released on 2013-04-03 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of a highly successful textbook, Mass Spectrometry, Third Edition provides students with a complete overview of the principles, theories and key applications of modern mass spectrometry. All instrumental aspects of mass spectrometry are clearly and concisely described: sources, analysers and detectors. Tandem mass spectrometry is introduced early on and then developed in more detail in a later chapter. Emphasis is placed throughout the text on optimal utilisation conditions. Various fragmentation patterns are described together with analytical information that derives from the mass spectra. This new edition has been thoroughly revised and updated and has been redesigned to give the book a more contemporary look. As with previous editions it contains numerous examples, references and a series of exercises of increasing difficulty to encourage student understanding. Updates include: Increased coverage of MALDI and ESI, more detailed description of time of flight spectrometers, new material on isotope ratio mass spectrometry, and an expanded range of applications. Mass Spectrometry, Third Edition is an invaluable resource for all undergraduate and postgraduate students using this technique in departments of chemistry, biochemistry, medicine, pharmacology, agriculture, material science and food science. It is also of interest for researchers looking for an overview of the latest techniques and developments.

The HPLC Expert II

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Publisher : John Wiley & Sons
ISBN 13 : 3527694978
Total Pages : 384 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis The HPLC Expert II by : Stavros Kromidas

Download or read book The HPLC Expert II written by Stavros Kromidas and published by John Wiley & Sons. This book was released on 2017-01-05 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can I use my HPLC/UHPLC equipment in an optimal way, where are the limitations of the technique? These questions are discussed in detail in the sequel of the successful "HPLC Expert" in twelve chapters written by experts in the respective fields. The topics encompass - complementary to the first volume - typical HPLC users' problems and questions such as gradient optimization and hyphenated techniques (LC-MS). An important key aspect of the book is UHPLC: For which analytical problem is it essential, what should be considered? Besides presentation of latest developments directly from the main manufacturers, also UHPLC users and independent service engineers impart their knowledge. Consistent with the target groups, the level is advanced, but the emphasis is on practical applications.

Principles and Practice of Modern Chromatographic Methods

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Publisher : Academic Press
ISBN 13 : 012822097X
Total Pages : 532 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Principles and Practice of Modern Chromatographic Methods by : Kevin Robards

Download or read book Principles and Practice of Modern Chromatographic Methods written by Kevin Robards and published by Academic Press. This book was released on 2021-12-03 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Modern Chromatographic Methods, Second Edition takes a comprehensive, unified approach in its presentation of chromatographic techniques. Like the first edition, the book provides a scientifically rigid, but easy-to-follow presentation of chromatography concepts that begins with the purpose and intent of chromatographic theory - the “what and why that are left out of other books attempting to cover these principles. This fully revised second edition brings the content up-to-date, covering recent developments in several new sections and an additional chapter on composite methods. New topics include sample profiling, sample preparation, sustainable green chemistry, 2D chromatography, miniaturization/nano-LC, HILIC, and more. Contains thorough chapters that begin with an updated schematic overview and a visual representation of the content Avoids the obfuscation of different terminologies and classification systems that are prevalent in the area, such as the relationship between liquid chromatography and column chromatography Provides integrated and comprehensive topic coverage based on chromatographic bibliometrics and survey reports on the relative usage of chromatographic techniques

Optimization in HPLC

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Publisher : John Wiley & Sons
ISBN 13 : 3527347895
Total Pages : 418 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Optimization in HPLC by : Stavros Kromidas

Download or read book Optimization in HPLC written by Stavros Kromidas and published by John Wiley & Sons. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to maximize the performance of your HPLC or UHPLC system with this resource from leading experts in the field Optimization in HPLC: Concepts and Strategies delivers tried-and-tested strategies for optimizing the performance of HPLC and UHPLC systems for a wide variety of analytical tasks. The book explains how to optimize the different HPLC operation modes for a range of analyses, including small molecules, chiral substances, and biomolecules. It also shows readers when and how computational tools may be used to optimize performance. The practice-oriented text describes common challenges faced by users and developers of HPLC and UHPLC systems, as well as how those challenges can be overcome. Written for first-time and experienced users of HPLC technology and keeping pace with recent developments in HPLC instrumentation and operation modes, this comprehensive guide leaves few questions unanswered. Readers will also benefit from the inclusion of: A thorough introduction to optimization strategies for different modes and uses of HPLC, including working under regulatory constraints An exploration of computer aided HPLC optimization, including ChromSwordAuto and Fusion QbD A treatment of current challenges for HPLC users in industry as well as large and small analytical service providers Discussions of current challenges for HPLC equipment suppliers Tailor-made for analytical chemists, chromatographers, pharmacologists, toxicologists, and lab technicians, Optimization in HPLC: Concepts and Strategies will also earn a place on the shelves of analytical laboratories in academia and industry who seek a one-stop reference for optimizing the performance of HPLC systems.

Handbook of Pharmaceutical Analysis by HPLC

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Author :
Publisher : Elsevier
ISBN 13 : 0080455182
Total Pages : 679 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by HPLC by : Satinder Ahuja

Download or read book Handbook of Pharmaceutical Analysis by HPLC written by Satinder Ahuja and published by Elsevier. This book was released on 2005-02-09 with total page 679 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Material Characterization Techniques and Applications

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Publisher : Springer Nature
ISBN 13 : 9811695695
Total Pages : 314 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Material Characterization Techniques and Applications by : Euth Ortiz Ortega

Download or read book Material Characterization Techniques and Applications written by Euth Ortiz Ortega and published by Springer Nature. This book was released on 2022-02-12 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents commonly applied characterization techniques in material science, their brief history and origins, mechanism of operation, advantages and disadvantages, their biosensing applications, and troubleshooting for each technique, while addressing the challenges researchers face when working with these techniques. The book dedicates its focus to identifying physicochemical and electrochemical nature of materials including analyses of morphology, mass spectrometry, and topography, as well as the characterization of elemental, structural, thermal, wettability, electrochemical, and chromatography properties. Additionally, the main features and benefits of using coupled characterization techniques are discussed in this book.

UHPLC in Life Sciences

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Publisher : Royal Society of Chemistry
ISBN 13 : 1782626158
Total Pages : 386 pages
Book Rating : 4.7/5 (826 download)

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Book Synopsis UHPLC in Life Sciences by : Davy Guillarme

Download or read book UHPLC in Life Sciences written by Davy Guillarme and published by Royal Society of Chemistry. This book was released on 2015-11-09 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its commercial introduction in 2004, UHPLC (Ultra-High Performance Liquid Chromatography) has begun to replace conventional HPLC in academia and industry and interest in this technique continues to grow. Both the increases in speed and resolution make this an attractive method; particularly to the life sciences and more than 1500 papers have been written on this strongly-evolving topic to date. This book provides a solid background on how to work with UHPLC and its application to the life sciences. The first part of the book covers the basics of this approach and the specifics of a UHPLC system, providing the reader with a solid background to working properly with such a system. The second part examines the application of UHPLC to the life sciences, with a focus on drug analysis strategies. UHPLC-MS, a key technique in pharmaceutical and toxicological analyses, is also examined in detail. The editors (Davy Guillarme and Jean-Luc Veuthey) were some of the earliest adopters of UHPLC and have published and lectured extensively on this topic. Between them they have brought together an excellent team of contributors from Europe and the United States, presenting a wealth of expertise and knowledge. This book is an essential handbook for anyone wishing to adopt an UHPLC system in either an academic or industrial setting and will benefit postgraduate students and experienced workers alike.

HPLC

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Author :
Publisher : CRC Press
ISBN 13 : 1420042661
Total Pages : 480 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis HPLC by : Joel K. Swadesh

Download or read book HPLC written by Joel K. Swadesh and published by CRC Press. This book was released on 2000-12-21 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product specifications, regulatory constraints, and tight production schedules impose considerable pressures on separation scientists in industry. The first edition of HPLC: Practical and Industrial Applications helped eliminate the need for extensive library or laboratory research when confronting a problem, an unfamiliar technique, or work in a n

High Performance Liquid Chromatography

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Publisher : CRC Press
ISBN 13 : 9780751400762
Total Pages : 292 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis High Performance Liquid Chromatography by : W.J. Lough

Download or read book High Performance Liquid Chromatography written by W.J. Lough and published by CRC Press. This book was released on 1995-09-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: High performance liquid chromatography (HPLC) has long been recognized as one of the most useful and versatile analytical techniques. It has now progressed from being a highly expensive method of analysis to a routine technique with wide applications. Consequently there is a requirement in many chemistry and chemistry-related courses for students to acquire a detailed understanding of the principles and practice of HPLC. Written in a manner suitable for undergraduate students studying analytical chemistry and learning about chromatographic analytical techniques applied to pharmaceutical analysis, biochemistry and related disciplines, High-performance Liquid Chromatography: Fundamental Principles and Practice introduces the fundamentals of HPLC. Loosely structured in three parts, the text begins with a thorough introduction of the subject and then progresses through the essential knowledge of the instrumentation needed for HPLC. The final part covers with the applications of HPLC in real-world situations. Developed by a team of international experts from a wide cross-section of disciplines, the text is relevant to a wide range of courses.

Pharmaceutical Analysis for Small Molecules

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Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 211 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.