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Stability Indicating Hplc Methods For Drug Analysis
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Book Synopsis Stability-indicating HPLC Methods for Drug Analysis by : Quanyun A. Xu
Download or read book Stability-indicating HPLC Methods for Drug Analysis written by Quanyun A. Xu and published by Pharmaceutical Press. This book was released on 2008 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stability-Indicating HPLC Methods for Drug Analysis compiles summaries of stability-indicating HPLC analytical methods that have appeared in the published literature. A first stop for pharmaceutical scientists, analytical chemists, and librarians in the quest for information about the stability of drugs. Co-published by the American Pharmaceutical Association and the Pharmaceutical Press, a division of the Royal Pharmaceutical Society of Great Britain.
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.
Book Synopsis Development of Novel Stability Indicating Methods Using Liquid Chromatography by : Mukesh Maithani
Download or read book Development of Novel Stability Indicating Methods Using Liquid Chromatography written by Mukesh Maithani and published by Springer. This book was released on 2019-08-07 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
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
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
Book Synopsis HPLC Methods on Drug Analysis by : Mantu K. Ghosh
Download or read book HPLC Methods on Drug Analysis written by Mantu K. Ghosh and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: The dramatic development of chromatographic techniques, specially high per formance or high pressure liquid chromatography (HPLC) has made possible the easy analysis of organic compounds, including drugs and drug components, for last two decades. This rapid increase and improvement of analytical methodology with HPLC has enabled researchers and scientists to cope with other scientific and instru mental developments in their fields of work. Thousands of impressive and original scientific publications, text books and monographs describe the techniques for drug analysis with high performance liquid chromatography. However, no concise presentation of the general proper ties of the drugs and their HPLC methodology exists together in the market. This work contains the general properties necessary for the analysis of 232 drugs as well as the HPLC methods for many other drugs and drug components. It is hoped that it will fill a gap and provide a precise survey of the HPLC methods for drug analysis. It is intended as an immediate guide in the laboratory and will be of help to the scientists, researchers and technicians in the field of analysis.
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.
Book Synopsis High Performance Liquid Chromatography & Capillary Electrophoresis by : Andrea Weston
Download or read book High Performance Liquid Chromatography & Capillary Electrophoresis written by Andrea Weston and published by Elsevier. This book was released on 1997-07-21 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: HPLC and CE: Principles and Practice presents the latest information on the most powerful separation techniques available: high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE). Fundamental theory, instrumentation, modes of operation, and optimization of separations are presented in a concise, non-technical style to help the user in choosing the appropriate technique quickly and accurately. Well- illustrated and containing convenientend-of-chapter summaries of the major concepts, the book provides in-depth coverage of trouble-shooting, improvement of resolution, data manipulation, selectivity, and sensitivity. Graduate students, technicians, and researchers who must use separations with little or no background in analytical chemistry can overcome separation anxiety and get started in obtaining the best possible separations in minimal time. The book will alsobe useful to analytical chemists who need a better understanding of theory and processes. Fully up-to-date information on both HPLC and CE includes troubleshooting and comparisons of the two techniques Applicable to a wide variety of separation problems Covers basic concepts governing any separation as well as instrumentation and how to use it Helps the user to obtain optimal resolution in minimal time Contains information on special procedures such as chiral separations, affinity chromatography, and sample preparation Includes information on upcoming trends such as miniaturization Major concepts in each chapter are organized to allow access to information easily and quickly Contains practical bibliography for accessing the literature
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 532 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
Book Synopsis Pharmaceutical Stress Testing by : Steven W. Baertschi
Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2016-04-19 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability
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 328 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.
Book Synopsis High-Performance Gradient Elution by : Lloyd R. Snyder
Download or read book High-Performance Gradient Elution written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2007-01-09 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gradient elution demystified Of the various ways in which chromatography is applied today, few have been as misunderstood as the technique of gradient elution, which presents many challenges compared to isocratic separation. When properly explained, however, gradient elution can be less difficult to understand and much easier to use than often assumed. Written by two well-known authorities in liquid chromatography, High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model takes the mystery out of the practice of gradient elution and helps remove barriers to the practical application of this important separation technique. The book presents a systematic approach to the current understanding of gradient elution, describing theory, methodology, and applications across many of the fields that use liquid chromatography as a primary analytical tool. This up-to-date, practical, and comprehensive treatment of gradient elution: * Provides specific, step-by-step recommendations for developing a gradient separation for any sample * Describes the best approach for troubleshooting problems with gradient methods * Guides the reader on the equipment used for gradient elution * Lists which conditions should be varied first during method development, and explains how to interpret scouting gradients * Explains how to avoid problems in transferring gradient methods With a focus on the use of linear solvent strength (LSS) theory for predicting gradient LC behavior and separations by reversed-phase HPLC, High-Performance Gradient Elution gives every chromatographer access to this useful tool.
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.
Download or read book Drugs written by Angelo Albini and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since Pasteur in 1846, scientists have been aware that many drugs are photoreactive, but until recently research in this area had been somewhat limited. However, since the introduction of acutely sensitive analytical methods, the realisation of the need to identify the photochemical properties of a potential drug as early in its development as possible and the increased attention to the phototoxic effect of drugs, more details are becoming available. Drugs: Photochemistry and Photostability presents the basic elements of the science, and serves as an excellent introduction to this emerging field of photochemistry. Detailed experimental conditions for photostability studies are given, along with a discussion of the recently implemented ICH Guidelines for drug photostability. With contributions from international experts in the field and including a comprehensive literature review, this book provides all the up-to-date information needed by researchers in many fields, especially medicinal and pharmaceutical chemistry.
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.
Book Synopsis Handbook of Analytical Validation by : Michael E. Swartz
Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
