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Stability Indicating Chromatographic Methods
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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.
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 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 Stability Indicating Chromatographic Methods by : Nasir Vadia
Download or read book Stability Indicating Chromatographic Methods written by Nasir Vadia and published by LAP Lambert Academic Publishing. This book was released on 2015-04-07 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a current scenario of a drug research and development, regulatory requirement is very stringent and much of importance that any new or established drug / drug formulation must remain stable till it will utilize by a patient. The stability issues are greatly influence the drug's therapeutic property hence it is important to maintain the all the factors and parameters which may alter the drugs physico-chemical properties. To study the effect of various environmental factors on drug stability, stability indicating method play vital role. In presented work we have mainly discussed two stability indicating analytical methods for single drug and drugs available in combinations. HPLC and HPTLC methods were developed and validated for the estimation of selected drugs. Selected drugs were acted upon various stressed conditions including acidic, alkali, photo, thermal etc and possible stability issues were studied. The developed methods were validated according to ICH guideline as it is universally accepted guideline for drug stability. Developed chromatographic methods were statistically compared and found that there were no any statistical difference amongst them.
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 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 295 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 Selective HPLC Method by : Hayam M. Lotfy
Download or read book Selective HPLC Method written by Hayam M. Lotfy and published by LAP Lambert Academic Publishing. This book was released on 2012 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: Selective HPLC method, Stability indicating high performance liquid chromatographic method, simultaneous precise determination of promethazine (PROM) and sodium benzoate (SBENZ), even in the presence of the main oxidative degradation products of PROM, Promethazine (PROM), like other phenothiazines, may become photobiologically active via formation of photolytic products, a number of them being cytotoxic, determination of the comparative protective effect of different antioxidants usually added. Different stability studies were planned to show any interference in the separation of PROM from SBENZ especially in the presence of some common auto-oxidation supressants, such as buylated hydroxy toluene (BHT), buylate hydroxy anisole (BHA) or sodium metabisulfite
Book Synopsis The Application of Green Solvents in Separation Processes by : Francisco Pena-Pereira
Download or read book The Application of Green Solvents in Separation Processes written by Francisco Pena-Pereira and published by Elsevier. This book was released on 2017-02-28 with total page 561 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Application of Green Solvents in Separation Processes features a logical progression of a wide range of topics and methods, beginning with an overview of green solvents, covering everything from water and organic solvents, to ionic liquids, switchable solvents, eutectic mixtures, supercritical fluids, gas-expanded solvents, and more. In addition, the book outlines green extraction techniques, such as green membrane extraction, ultrasound-assisted extraction, and surfactant-mediated extraction techniques. Green sampling and sample preparation techniques are then explored, followed by green analytical separations, including green gas and liquid capillary chromatography, counter current chromatography, supercritical fluid chromatography, capillary electrophoresis, and other electrical separations. Applications of green chemistry techniques that are relevant for a broad range of scientific and technological areas are covered, including the benefits and challenges associated with their application. Provides insights into recent advances in greener extraction and separation processes Gives an understanding of alternatives to harmful solvents commonly used in extraction and separation processes, as well as advanced techniques for such processes Written by a multidisciplinary group of internationally recognized scientists
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 Green Analytical Chemistry by : Mihkel Koel
Download or read book Green Analytical Chemistry written by Mihkel Koel and published by Royal Society of Chemistry. This book was released on 2010 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to green chemistry Concepts and trends in green analytical chemistry "Greening" sample preparation Green instrumental analysis "Greening" signal acquisition and processing Conclusions This book describes the applications, ideas and concepts of green chemistry in chemical analysis and evaluates the performance of current methodologies.
Book Synopsis Principles and Applications of Clinical Mass Spectrometry by : Nader Rifai
Download or read book Principles and Applications of Clinical Mass Spectrometry written by Nader Rifai and published by Elsevier. This book was released on 2018-06-26 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Applications of Clinical Mass Spectrometry: Small Molecules, Peptides, and Pathogens is a concise resource for quick implementation of mass spectrometry methods in clinical laboratory work. Focusing on the practical use of these techniques, the first half of the book covers principles of chromatographic separations, principles and types of mass spectrometers, and sample preparation for analysis; the second half outlines the main applications of this technology within clinical laboratory settings, including determination of small molecules and peptides, as well as pathogen identification. A thorough yet succinct guide to using mass spectrometry technology in the clinical laboratory, Principles and Applications of Clinical Mass Spectrometry: Small Molecules, Peptides, and Pathogens is an essential resource for chemists, pharmaceutical and biotech researchers, certain government agencies, and standardization groups. Provides concrete examples of the main applications of mass spectrometry technology Describes current capabilities of the LC- and MS-based analytical methods Details methods for successful analytical work in the field
Book Synopsis Biochemical Analysis Tools by : Oana-Maria Boldura
Download or read book Biochemical Analysis Tools written by Oana-Maria Boldura and published by BoD – Books on Demand. This book was released on 2020-06-24 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the role of nucleic acid analysis and the advances it has led to in the field of life sciences. The first section is a collection of chapters covering experimental methods used in molecular biology, the techniques adjacent to these methods, and the steps of analysis before and after obtaining raw DNA data. The second section deals with the principles of chromatography, method development, sample preparation, and industrial applications.
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
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 Applications of Ion Chromatography for Pharmaceutical and Biological Products by : Lokesh Bhattacharyya
Download or read book Applications of Ion Chromatography for Pharmaceutical and Biological Products written by Lokesh Bhattacharyya and published by John Wiley & Sons. This book was released on 2012-02-10 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.
Book Synopsis Analysis of Pharmaceuticals by Capillary Electrophoresis by : Kevin D. Altria
Download or read book Analysis of Pharmaceuticals by Capillary Electrophoresis written by Kevin D. Altria and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieser erste Titel einer ganzen Serie von anwendungsbezogenen Handbüchern zur Kapillarelektrophorese beschäftigt sich mit der Analytik von pharmazeutischen Substanzen. Dabei werden verschiedene Techniken praxisnah erläutert. Jeder, der im Labor - ob wissenschaftlich oder praxisnah - mit der Analyse von oft chiralen Pharmazeutika konfrontiert ist, wird viele Hinweise und Tips für seine Arbeit finden.USP: Einzige Monographie zur Analyse von Pharmazeutika mit CE This book describes the current state of the art for the analysis of pharmaceuticals by capillary electrophoresis and contains several hundred references to specific applications and methods. The main purpose of the book is to present the application possibilities of CE an therefore tabulated application data are provided. Chapters of the book are devoted to providing details of individual application areas such as chiral analysis, determination of drug related impurities, determination of drug counter-ions, drug residue monitoring and main component assay. An introductory chapter provides theoretical background to CE an related techniques. A chapter is dedicated to capillary electrochromatography which highlights the importance this technique currently possesses. Successful regulatory acceptance of CE methods is also described. A comprehensive chapter covers method validation aspects. Other chapters include discrete areas such as the use of non-aqueous solvents, forensic applications of CE, the application of experimental designs, determination of drugs in biofluids, and the analysis of vitamins by CE.
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.
