HPLC Methods for Recently Approved Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 0471711675
Total Pages : 743 pages
Book Rating : 4.4/5 (717 download)

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Book Synopsis HPLC Methods for Recently Approved Pharmaceuticals by : George Lunn

Download or read book HPLC Methods for Recently Approved Pharmaceuticals written by George Lunn and published by John Wiley & Sons. This book was released on 2005-05-06 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

HPLC Method Development for Pharmaceuticals

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Author :
Publisher : Elsevier
ISBN 13 : 0080554199
Total Pages : 533 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis HPLC Method Development for Pharmaceuticals by : Satinder Ahuja

Download or read book HPLC Method Development for Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2011-09-21 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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.

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

HPLC in the Pharmaceutical Industry

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Author :
Publisher : CRC Press
ISBN 13 : 9780824784997
Total Pages : 332 pages
Book Rating : 4.7/5 (849 download)

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Book Synopsis HPLC in the Pharmaceutical Industry by : Godwin W. Fong

Download or read book HPLC in the Pharmaceutical Industry written by Godwin W. Fong and published by CRC Press. This book was released on 1991-03-14 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an

Method Validation in Pharmaceutical Analysis

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Analytical Method Development and Validation

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Author :
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz

Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

HPLC of Peptides and Proteins

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Publisher : Springer Science & Business Media
ISBN 13 : 1592597424
Total Pages : 411 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis HPLC of Peptides and Proteins by : Marie-Isabel Aguilar

Download or read book HPLC of Peptides and Proteins written by Marie-Isabel Aguilar and published by Springer Science & Business Media. This book was released on 2008-02-03 with total page 411 pages. Available in PDF, EPUB and Kindle. Book excerpt: The introduction of high-performance liquid chromatography (HPLC) to the analysis of peptides and proteins some 25 years ago revolutionized the biological sciences by enabling the rapid and sensitive analysis of peptide and protein structure through the exquisite speed, sensitivity, and resolution that can be easily obtained. Today, HPLC in its various modes has become the pivotal technique in the characterization of peptides and proteins and currently plays a critical role in both our understanding of biological processes and in the development of peptide- and protein-based pharmaceuticals. The number of applications of HPLC in peptide and protein purification continues to expand at an extremely rapid rate. Solid-phase peptide synthesis and recombinant DNA techniques have allowed the production of large quantities of peptides and proteins that need to be highly purified. HPLC techniques are also used extensively in the isolation and characterization of novel proteins that will become increasingly important in the postgenomic age. The design of multidimensional purification schemes to achieve high levels of product purity further demonstrates the power of HPLC techniques not only in the characterization of cellular events, but also in the production of pepti- and protein-based therapeutics. HPLC continues to be at the heart of the analytical techniques with which scientists in both academia and in industry must arm themselves to be able to fully characterize the identity, purity, and potency of peptides and proteins.

Modern HPLC for Practicing Scientists

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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.

Analytical Techniques in the Pharmaceutical Sciences

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Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

An Introduction to HPLC for Pharmaceutical Analysis

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Author :
Publisher : Lulu.com
ISBN 13 : 0956152805
Total Pages : 150 pages
Book Rating : 4.9/5 (561 download)

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Book Synopsis An Introduction to HPLC for Pharmaceutical Analysis by : Oona McPolin

Download or read book An Introduction to HPLC for Pharmaceutical Analysis written by Oona McPolin and published by Lulu.com. This book was released on 2009-03-01 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.

Destruction of Hazardous Chemicals in the Laboratory

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Publisher : John Wiley & Sons
ISBN 13 : 111814659X
Total Pages : 795 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Destruction of Hazardous Chemicals in the Laboratory by : George Lunn

Download or read book Destruction of Hazardous Chemicals in the Laboratory written by George Lunn and published by John Wiley & Sons. This book was released on 2012-05-01 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book describes practical procedures for the destruction of hazardous chemicals and biological agents in the laboratory in which they are used. The book is a continuation and expansion of “Destruction of Hazardous Chemicals in the Laboratory.” It follows the same general approach as the first and second editions but includes a number of new chapters including one on using advanced oxidation techniques as a general means of degrading chemicals. All the monographs from the second edition are incorporated in this volume and are revised and extended as necessary. A number of new monographs describing procedures for the destruction of hazardous chemicals have also been added. The destruction of many pharmaceuticals is also described in this book. This subject has become of increasing importance with recent reports of the detection of pharmaceuticals in the water supply. Finally a new addition is the chapter “General Methods for the Destruction of Hazardous Chemicals in the Laboratory.” This chapter describes recent advanced oxidation methods that should be generally applicable to all organic compounds. The methods use commonly available laboratory equipment and reagents.

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.

Validation of Analytical Methods for Pharmaceutical Analysis

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Publisher : Lulu.com
ISBN 13 : 0956152813
Total Pages : 154 pages
Book Rating : 4.9/5 (561 download)

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Book Synopsis Validation of Analytical Methods for Pharmaceutical Analysis by : Oona McPolin

Download or read book Validation of Analytical Methods for Pharmaceutical Analysis written by Oona McPolin and published by Lulu.com. This book was released on 2009-05-01 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

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.

Handbook of Stability Testing in Pharmaceutical Development

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

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Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.