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Identification and Determination of Impurities in Drugs

Identification and Determination of Impurities in Drugs Author S. Görög
ISBN-10 0080534406
Release 2000-05-19
Pages 772
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Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis. Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book. The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.

High Throughput Bioanalytical Sample Preparation

High Throughput Bioanalytical Sample Preparation Author David A. Wells
ISBN-10 9780444635846
Release 2017-06-01
Pages 750
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High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies, Second Edition, is the go-to resource for industrial analytical chemists and others seeking the latest techniques for optimizing sample preparation in their everyday workflow. Outlining the latest preparation techniques from around the globe, this helpful guide provides answers to questions, including 'How do I automate a procedure?', 'How do I work to reduce matrix interferences?' 'Could I do this procedure online instead of in a manual batch?' 'What sorbent materials are available in the market?' 'How do I use a cation exchange resin?' 'What has been published on micro-sampling techniques?', and more. Featuring detailed coverage of the newer techniques that have emerged since the first edition was published, the book includes discussions on micro sampling and molecularly imprinted polymers, addresses the workflow pain points associated with extraction process efficiency, and outlines exactly how to optimize productivity through enhanced method development. Combining a step-by-step approach with a thorough explanation of the technology, this new edition features 40% new content and 60% revised content, accurately and thoroughly capturing the latest developments in research since the previous edition published in 2003. Offers broad coverage of all sample preparation methods and techniques, including the latest industry developments in bioanalysis Provides detailed ‘How-To’ approaches for each technique, making its applications immediately implementable Authored by an industry analytical chemist who has more than 30 years of experience in all facets of sample preparation, drug analysis, and more Features a thorough and inclusive bibliography of related publications in the field

Carbamates Advances in Research and Application 2012 Edition

Carbamates   Advances in Research and Application  2012 Edition Author
ISBN-10 9781481603201
Release 2012-12-26
Pages 120
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Carbamates—Advances in Research and Application: 2012 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Carbamates. The editors have built Carbamates—Advances in Research and Application: 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Carbamates in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Carbamates—Advances in Research and Application: 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at

Pharmaceutical and Biomedical Applications of Liquid Chromatography

Pharmaceutical and Biomedical Applications of Liquid Chromatography Author W.J. Lough
ISBN-10 9780080984544
Release 2013-10-22
Pages 393
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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.

Novel Developments in Pharmaceutical and Biomedical Analysis

Novel Developments in Pharmaceutical and Biomedical Analysis Author Atta-ur- Rahman
ISBN-10 9781681085746
Release 2018-04-24
Pages 360
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Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents information about a selection of analytical techniques. Readers will find information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. Novel Developments in Pharmaceutical and Biomedical Analysis is the second volume of the series and covers the following topics: o Chromatographic assays of solid dosage forms and their drug dissolution studies o UHPLC method for the estimation of bioactive compounds o HILIC based LC/MS for metabolite analysis o In vitro methods for the evaluation of oxidative stress o Application of vibrational spectroscopy in studies of structural polymorphism of drugs o Electrochemical sensors based on conductive polymers and carbon nanotubes o Optical sensor arrays for pharmaceutical and biomedical analyses o Chemical applications of ionic liquids o New trends in enantioanalysis of pharmaceutical compounds.

Advances in Chromatography

Advances in Chromatography Author Eli Grushka
ISBN-10 9781439858455
Release 2012-01-27
Pages 465
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For more than four decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications. For Volume 50, the series editors have invited established, well-known chemists from across the globe to offer cutting-edge reviews on their areas of expertise. The clear presentation of topics and vivid illustrations for which this series has become known makes the material accessible and engaging to analytical, biochemical, organic, polymer, and pharmaceutical chemists at all levels of technical skill.

Journal of Chromatography

Journal of Chromatography Author
ISBN-10 CHI:61564045
Release 2002
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Journal of Chromatography has been writing in one form or another for most of life. You can find so many inspiration from Journal of Chromatography also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Journal of Chromatography book for free.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs Author Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
ISBN-10 9780309269391
Release 2013-05-20
Pages 351
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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Books in Print

Books in Print Author
ISBN-10 UOM:39015054048460
Release 2004
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Books in print is the major source of information on books currently published and in print in the United States. The database provides the record of forthcoming books, books in-print, and books out-of-print.

High Throughput Bioanalytical Sample Preparation

High Throughput Bioanalytical Sample Preparation Author David A. Wells
ISBN-10 044451029X
Release 2003-01
Pages 610
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Several chapters introduce and discuss microplates, accessory products and automation devices. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The subject material then reviews protein precipitation, liquid-liquid extraction, solid-phase extraction and various on-line sample preparation approaches. The book concludes with information on recent advances in sample preparation, such as solid-phase extraction in a card format and higher density extraction plates. Important objectives that can be accomplished when the strategies presented in this book are followed include: improved efficiency in moving discovery compounds to preclinical status with robust analytical methods; return on investment in automation for sample preparation; and improved knowledge and expertise of laboratory staff.-

Identification and Quantification of Drugs Metabolites and Metabolizing Enzymes by LC MS

Identification and Quantification of Drugs  Metabolites and Metabolizing Enzymes by LC MS Author Swapan Chowdhury
ISBN-10 0080456065
Release 2005-11-04
Pages 354
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As new techniques of transferring from liquid to gas phase and measuring masses of drug molecules and metabolites become more prevalent, so do the technical challenges of putting these techniques into proper use, as well as the task of consolidating emerging applications. Identification and Quantification of Drugs, Metabolites and Metabolizing Enzymes by LC-MS, Volume 6 fills the gap in the lack of presently available literature by providing a critical review in the current use of liquid chromatography-mass spectrometry (LC-MS) in drug discovery and development. With chapters written by experts with a wide range of practical experience from the pharmaceutical industry, emphasis is placed on techniques and applications. The book also includes chapters on how to utilize LC-MS instrumentation for current drug metabolism problems. This book is intended for those beginning to use LC-MS for drug metabolism studies as well as for those considered advanced practitioners. * Introduces readers to the practical applications of modern liquid chromatography-mass spectrometry (LC-MS) in a wide range of drug metabolism studies· * Provides a comprehensive description of different forms of metabolites, with detailed discussion on the wide range of methodologies used to identify them * Highlights problems associated with drug quantification and offers practical solutions

Indian Journal of Chemical Technology

Indian Journal of Chemical Technology Author
ISBN-10 UOM:39015058333330
Release 2001
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Indian Journal of Chemical Technology has been writing in one form or another for most of life. You can find so many inspiration from Indian Journal of Chemical Technology also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Indian Journal of Chemical Technology book for free.

Medical Applications of Mass Spectrometry

Medical Applications of Mass Spectrometry Author Karoly Vekey
ISBN-10 9780080554655
Release 2011-08-11
Pages 606
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Mass spectrometry is fast becoming an indispensable field for medical professionals. The mass spectrometric analysis of metabolites and proteins promises to revolutionize medical research and clinical diagnostics. As this technology rapidly enters the medical field, practicing professionals and students need to prepare to take full advantage of its capabilities. Medical Applications of Mass Spectrometry addresses the key issues in the medical applications of mass spectrometry at the level appropriate for the intended readership. It will go a long way to help the utilization of mass spectrometry in medicine. The book comprises five parts. A general overview is followed by a description of the basic sampling and separation methods in analytical chemistry. In the second part a solid foundation in mass spectrometry and modern techniques of data analysis is presented. The third part explains how mass spectrometry is used in exploring various classes of biomolecules, including proteins and lipids. In the fourth section mass spectrometry is introduced as a diagnostic tool in clinical treatment, infectious pathogen research, neonatal diagnostics, cancer, brain and allergy research, as well as in various fields of medicine: cardiology, pulmonology, neurology, psychiatric diseases, hemato-oncology, urologic diseases, gastrointestinal diseases, gynecology and pediatrics. The fifth part covers emerging applications in biomarker discovery and in mass spectrometric imaging. * Provides a broad look at how the medical field is benefiting from advances in mass spectrometry. * Guides the reader from basic principles and methods to cutting edge applications. * There is NO comparable book on the market to fill this fast growing field.

Pharmaceutical Drug Analysis

Pharmaceutical Drug Analysis Author Ashutosh Kar
ISBN-10 8122415822
Release 2007-01-01
Pages 554
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During The Past Two Decades, There Have Been Magnificent And Significant Advances In Both Analytical Instrumentation And Computerized Data Handling Devices Across The Globe. In This Specific Context The Remarkable Proliferation Of Windows-Based Computer Software Stretched Overwhelmingly Towards Instrument Control, Real Time Data Handling Abilities And The Ultimate Usage Of Laboratory Information Management Systems (Lims) Are Surprisingly Noteworthy.Pharmaceutical Drug Analysis In Its Present Form Essentially Comprises Six Parts Containing In All 32 Well-Elaborated Chapters Predominantly Dealing With The Set Of Descriptive Analytical Methodologies Developed To Control And Assure The Quality Of The Final Marketed Product; And, Therefore, Includes Both Qualitative And Quantitative Methods Of Analysis To Help In The Identification As Well As Purity Of The Product.The Main Purpose Of This Textbook Is To Discuss In An Explicit And Lucid Manner Several Of The Newer Methods That Now Find Rather Wider Application In The Domain Of Pharmaceutical Analysis. The Basic Principle Of Each Technique Is Critically Treated With Emphasis On Factors That Directly Affect Its Proper And Judicious Application To Various Analytical Problems. An In-Depth Knowledge Of These Principles, Instrumentations, Modus Operandi, Experimental Parameters, And Sample Preparation Procedures In Order To Optimize The Performance Procedure Of Typical Assay Of Pharmaceutical Secondary Products I.E., Dosage Forms, Calculations Etc., Along With Cognate Assays From The Official Compendia Have Been Included Profusely.Undergraduate And Postgraduate Students Of Pharmaceutical Drug Analysis, Quality Assurance Chemists, Industrial Trainees, Bulk-Drug Professionals And Those In Related Disciplines Earnestly Requiring A Substantial Fundamental Understanding And Knowledge Of The Subject Will Certainly Find This A Much Needed Suitable Compilation For Reading And Reference.The Broad Coverage Included In Each Of The Selected Analytical Techniques Would Render Pharmaceutical Drug Analysis To Be An Useful Source Of Ideas, Inspiration For Research, And Developing Newer Practical Solutions To Problems In The Ever Expanding Field Of Pharmaceutical Analysis.

Genotoxic Impurities

Genotoxic Impurities Author Andrew Teasdale
ISBN-10 9780470934753
Release 2011-03-29
Pages 444
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This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Author Shayne Cox Gad
ISBN-10 0470259809
Release 2008-03-21
Pages 1384
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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals Author Satinder Ahuja
ISBN-10 9780080507767
Release 2003-06-26
Pages 430
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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.