Liquid Chromatography In Pharmaceutical Development
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Liquid Chromatography In Pharmaceutical Development
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Author : Irving W. Wainer
language : en
Publisher:
Release Date : 1985
Liquid Chromatography In Pharmaceutical Development written by Irving W. Wainer and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985 with Chromatography, Liquid categories.
Hplc Method Development For Pharmaceuticals
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2011-09-21
Hplc Method Development For Pharmaceuticals written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-21 with Medical categories.
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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Author : Yuri V. Kazakevich
language : en
Publisher: John Wiley & Sons
Release Date : 2007-02-16
Hplc For Pharmaceutical Scientists written by Yuri V. Kazakevich and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-16 with Science categories.
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.
Development Of Novel Stability Indicating Methods Using Liquid Chromatography
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Author : Mukesh Maithani
language : en
Publisher: Springer
Release Date : 2019-08-07
Development Of Novel Stability Indicating Methods Using Liquid Chromatography written by Mukesh Maithani and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-07 with Medical categories.
Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a ‘how-to guide’ to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.
An Introduction To Hplc For Pharmaceutical Analysis
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Author : Oona McPolin
language : en
Publisher: Lulu.com
Release Date : 2009-03-01
An Introduction To Hplc For Pharmaceutical Analysis written by Oona McPolin and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-01 with Medical categories.
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.
Liquid Chromatography
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Author : R. Szucs
language : en
Publisher: Elsevier Inc. Chapters
Release Date : 2013-01-08
Liquid Chromatography written by R. Szucs and has been published by Elsevier Inc. Chapters this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-08 with Science categories.
The primary focus of separation scientists supporting pharmaceutical drug development is to provide evidence of safety of medicines administered to patients and volunteers during clinical trials. This critical objective is achieved through application of various forms of state-of-the-art separation science techniques, often combined with spectroscopic detection techniques. The role of separation science, which plays a pivotal role in all phases of pharmaceutical drug development, is extensively described in the introductory part of this contribution. The early stages of pharmaceutical drug development typically require chromatographic techniques that provide very high resolution. This is essential as, at this stage of development, a relatively large number of process-related impurities, synthetic intermediates, and degradation products must be separated to characterize starting materials and products of chemical synthesis. In the first part of this chapter, we focus on multiple ways of enhancing chromatographic resolution for the purposes of satisfying these early development demands. In the later stages of the drug development process, when the manufacturing processes are being qualified, the emphasis shifts from resolution to speed, ruggedness, and robustness. The second part of this chapter provides an overview of useful tools and techniques that may be applied in such a setting. In the final part of this chapter, we ocus on novel trends in chromatographic method development related to the analytical quality by design initiative (AQbD).
Modern Hplc For Practicing Scientists
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Author : Michael W. Dong
language : en
Publisher: John Wiley & Sons
Release Date : 2016-04-06
Modern Hplc For Practicing Scientists written by Michael W. Dong and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-06 with Science categories.
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.
Handbook Of Pharmaceutical Analysis By Hplc
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2005-02-09
Handbook Of Pharmaceutical Analysis By Hplc written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-09 with Medical categories.
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
Pharmaceutical And Biomedical Applications Of Liquid Chromatography
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Author : W.J. Lough
language : en
Publisher: Newnes
Release Date : 2013-10-22
Pharmaceutical And Biomedical Applications Of Liquid Chromatography written by W.J. Lough and has been published by Newnes this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-22 with Medical categories.
This volume reflects the changes that have taken place in the pharmaceutical industry over the last ten years, most notably the increased importance attached to the question of chirality, the growing influence of biotechnology and the need for more rigorous documentation and validation of analytical methods and procedures. The first part of this book deals with the application of new technology to pharmaceutical and biomedical analysis, reflecting the present needs for increased speed, sensitivity and selectivity in the analysis of drugs. The second chapter provides an overview of capillary electophoresis, which represents one of the most inportant analytical developments to impact directly on pharmaceutical development in recent years. Although not a chromatographic technique, capillary electrophoresis was considered too important to be ignored. Over the last 25 years, liquid chromatography has grown into a mature analytical technique and many of the fundamental issues concerned with retention and separation are well defined. The practitioners of modern liquid chromatography spend as much time in the development of techniques for sampling handling and automation as they do in the development of the separation. Therefore, Part Two of this book describes some of the recent advances in the areas of sample handling and the isolation of compounds from biological samples, including solid phase extraction, restricted access media for direct injection, coupled column technology and microdialysis. Similarily, Part Three contains two chapters concerned with liquid chromatographic methods for the isolation of drug substances, peptides and proteins from other complex media. The pharmaceutical industry and the process of drug development are highly regulated and the increasing importance that the regulatory authorities attach to validation has had a significant impact on the analytical techniques used for the analysis of drugs. Although this has increased the workload of analysts in the pharmaceutical industry, it has also improved the quality of analytical methods used in the support of investigational and new drug applications as well as the quality of methods published more recently in the literature. Consequently, Part Four of this volume describes approaches to the optimization and validation of liquid chromatography methods for the analysis of drugs in the bulk form, in pharmaceutical formulations and biological fluids.
High Throughput Analysis In The Pharmaceutical Industry
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Author : Perry G. Wang
language : en
Publisher: CRC Press
Release Date : 2008-08-20
High Throughput Analysis In The Pharmaceutical Industry written by Perry G. Wang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-08-20 with Medical categories.
The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corres
