Handbook of Pharmaceutical Analysis by HPLC

by Satinder Ahuja

Author	: Satinder Ahuja
Publisher	: Elsevier
Total Pages	: 679
Release	: 2005-02-09
Genre	: Medical
ISBN	: 0080455182

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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

by Satinder Ahuja

Author	: Satinder Ahuja
Publisher	: Academic Press
Total Pages	: 604
Release	: 2010-11-11
Genre	: Medical
ISBN	: 0123759811

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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

HPLC Methods for Recently Approved Pharmaceuticals

by George Lunn

Author	: George Lunn
Publisher	: John Wiley & Sons
Total Pages	: 743
Release	: 2005-05-06
Genre	: Science
ISBN	: 0471711675

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An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods

Modern Methods of Pharmaceutical Analysis, Second Edition, Volume II

by Roger E. Schirmer

Author	: Roger E. Schirmer
Publisher	: CRC Press
Total Pages	: 466
Release	: 2024-11-01
Genre	: Science
ISBN	: 1040290612

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This book reviews several of the newer methods that find wide application in pharmaceutical analysis, as well as several older methods of unique importance. The principle of each technique is discussed with emphasis on factors that directly affect its proper application to analytical problems .

HPLC for Pharmaceutical Scientists

by Yuri V. Kazakevich

Author	: Yuri V. Kazakevich
Publisher	: John Wiley & Sons
Total Pages	: 1136
Release	: 2007-02-16
Genre	: Science
ISBN	: 0470087943

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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.

Method Validation in Pharmaceutical Analysis

by Joachim Ermer

Author	: Joachim Ermer
Publisher	: John Wiley & Sons
Total Pages	: 418
Release	: 2006-03-06
Genre	: Science
ISBN	: 3527604472

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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.

Modern HPLC for Practicing Scientists

by Michael W. Dong

Author	: Michael W. Dong
Publisher	: John Wiley & Sons
Total Pages	: 285
Release	: 2016-04-06
Genre	: Science
ISBN	: 111929360X

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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.

HPLC Methods for Pharmaceutical Analysis

by George Lunn

Author	: George Lunn
Publisher	: Wiley-Interscience
Total Pages	: 1860
Release	: 1997
Genre	: Medical
ISBN	:

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Full text included in Knovel Library within the subject area of Chemistry and Chemical Engineering.

Analytical Method Development and Validation

by Michael E. Swartz

Author	: Michael E. Swartz
Publisher	: CRC Press
Total Pages	: 95
Release	: 2018-10-03
Genre	: Science
ISBN	: 1482229773

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.