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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.



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 http://www.ScholarlyEditions.com/.



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
Pages
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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.



Books in Print

Books in Print Author
ISBN-10 UOM:39015054048460
Release 2004
Pages
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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.-



Indian Journal of Chemical Technology

Indian Journal of Chemical Technology Author
ISBN-10 UOM:39015058333330
Release 2001
Pages
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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.



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.



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.



Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry Author Guodong Chen
ISBN-10 9780470922972
Release 2011-04-27
Pages 496
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The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.



American Book Publishing Record

American Book Publishing Record Author
ISBN-10 STANFORD:36105111052903
Release 2002
Pages
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American Book Publishing Record has been writing in one form or another for most of life. You can find so many inspiration from American Book Publishing Record also informative, and entertaining. Click DOWNLOAD or Read Online button to get full American Book Publishing Record book for free.



Handbook of Solubility Data for Pharmaceuticals

Handbook of Solubility Data for Pharmaceuticals Author Abolghasem Jouyban
ISBN-10 1439804885
Release 2009-08-26
Pages 552
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Aqueous solubility is one of the major challenges in the early stages of drug discovery. One of the most common and effective methods for enhancing solubility is the addition of an organic solvent to the aqueous solution. Along with an introduction to cosolvency models, the Handbook of Solubility Data for Pharmaceuticals provides an extensive database of solubility for pharmaceuticals in mono solvents and binary solvents. Aqueous solubility data can be found in the Handbook of Aqueous Solubility Data by Samuel Yalkowsky and Yan He. Visit www.crcpress.com for more information. In addition to the experimental efforts to measure the solubility of drugs in mono and mixed solvents, this book discusses the advantages and limitations of a number of mathematical models used to predict the solubility in mono or mixed solvent systems. It covers the pharmaceutical cosolvents and other organic solvents that are used in syntheses, separations, and other pharmaceutical processes. The solutes featured include the available data for official drugs, drug candidates, precursors of drugs, metabolites, and degradation products of pharmaceuticals. The author also presents the solubilities of amino acids since they play an important role in peptide drug properties. Collecting drug solubilities in various cosolvents, this time-saving handbook includes the mixtures and model constants needed to predict undetermined solubilities. It describes mathematical models that enable data to be derived and provides estimates on how drugs are likely to behave in a given cosolvent. A software program and associated user manual are available on the author’s website.



Subject Guide to Books in Print

Subject Guide to Books in Print Author
ISBN-10 STANFORD:36105025888517
Release 2003
Pages
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Subject Guide to Books in Print has been writing in one form or another for most of life. You can find so many inspiration from Subject Guide to Books in Print also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Subject Guide to Books in Print book for free.



NMR Spectroscopy in Pharmaceutical Analysis

NMR Spectroscopy in Pharmaceutical Analysis Author Iwona Wawer
ISBN-10 9780080951522
Release 2017-07-07
Pages 528
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For almost a decade, quantitative NMR spectroscopy (qNMR) has been established as valuable tool in drug analysis. In all disciplines, i. e. drug identification, impurity profiling and assay, qNMR can be utilized. Separation techniques such as high performance liquid chromatography, gas chromatography, super fluid chromatography and capillary electrophoresis techniques, govern the purity evaluation of drugs. However, these techniques are not always able to solve the analytical problems often resulting in insufficient methods. Nevertheless such methods find their way into international pharmacopoeias. Thus, the aim of the book is to describe the possibilities of qNMR in pharmaceutical analysis. Beside the introduction to the physical fundamentals and techniques the principles of the application in drug analysis are described: quality evaluation of drugs, polymer characterization, natural products and corresponding reference compounds, metabolism, and solid phase NMR spectroscopy for the characterization drug substances, e.g. the water content, polymorphism, and drug formulations, e.g. tablets, powders. This part is accompanied by more special chapters dealing with representative examples. They give more detailed information by means of concrete examples. Combines theory, techniques, and concrete applications—all of which closely resemble the laboratory experience Considers international pharmacopoeias, addressing the concern for licensing Features the work of academics and researchers, appealing to a broad readership



Xenobiotica

Xenobiotica Author
ISBN-10 UCLA:L0067453043
Release 1992
Pages
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Xenobiotica has been writing in one form or another for most of life. You can find so many inspiration from Xenobiotica also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Xenobiotica book for free.