Capillary Electrophoresis Methods For Pharmaceutical Analysis

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Analysis of Pharmaceuticals by Capillary Electrophoresis

Author : Kevin D. Altria
Publisher : Springer Science & Business Media
ISBN 13 : 3322850110
Total Pages : 300 pages
Book Rating : 4.3/5 (228 download)

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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.

Capillary Electrophoresis Methods for Pharmaceutical Analysis

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080559611
Total Pages : 546 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Capillary Electrophoresis Methods for Pharmaceutical Analysis by : Satinder Ahuja

Download or read book Capillary Electrophoresis Methods for Pharmaceutical Analysis written by Satinder Ahuja and published by Elsevier. This book was released on 2011-08-09 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control.- Provides current status and future developments in CE analysis of pharmaceuticals.- Explains how to develop and validate methods.- Includes major pharmaceutical applications including assays and impurity testing.

Practical Capillary Electrophoresis

Author : Robert Weinberger
Publisher : Academic Press
ISBN 13 :
Total Pages : 488 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Practical Capillary Electrophoresis by : Robert Weinberger

Download or read book Practical Capillary Electrophoresis written by Robert Weinberger and published by Academic Press. This book was released on 2000-02-16 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary zone electrophoresis : basic concepts -- Capillary zone electrophoresis : methods development -- Capillary zone electrophoresis : secondary equilibrium, micelles, cyclodextrins, and related reagents -- Capillary isoelectric focusing -- Size separations in capillary gels and polymer networks -- Capillary electrochromatography -- Injection -- Detection -- Putting it all together.

Capillary Gel Electrophoresis

Author : Andras Guttman
Publisher : Newnes
ISBN 13 : 0080931359
Total Pages : 391 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Capillary Gel Electrophoresis by : Andras Guttman

Download or read book Capillary Gel Electrophoresis written by Andras Guttman and published by Newnes. This book was released on 2021-12-04 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary Gel Electrophoresis and Related Microseparation Techniques covers all theoretical and practical aspects of capillary gel electrophoresis. It also provides an excellent overview of the key application areas of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods. It not only gives readers a better understanding of how to utilize this technology, but also provides insights into how to determine which method will provide the best technical solutions to particular problems. This book can also serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses. - Covers all theoretical and practical aspects of capillary gel electrophoresis - Excellent overview of the key applications of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods - Teaches readers how to use the technology and select methods that are ideal for fundamental problems - Can serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses

Capillary Electrophoresis: Principles and Practice

Author : Reinhard Kuhn
Publisher : Springer Science & Business Media
ISBN 13 : 364278058X
Total Pages : 381 pages
Book Rating : 4.6/5 (427 download)

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Book Synopsis Capillary Electrophoresis: Principles and Practice by : Reinhard Kuhn

Download or read book Capillary Electrophoresis: Principles and Practice written by Reinhard Kuhn and published by Springer Science & Business Media. This book was released on 2013-03-07 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary electrophoresis (CE) is a brand-new analytical me- thod with the capability of solving many analytical separa- tion problems very fast and economically. This method gives new information about the investigated substances which can- not easily be obtained by other means. CE has become an established method only recently, but will be implemented in almost every analytical laboratory in industry, service units and academia in the near future. The most important fields of CE application are pharmaceutical and biochemical research and quality control. The authors have exhaustive practical experience in the application of CE methods in the pharmaceutical industry and provide the reader with a comprehensive treatment of this method. The main focus is on how to solve problems when applying CE in the laboratory. Physico-chemical theory is only dealt with in depth when necessary to understand the underlying separation mechanisms in order to solve your problems at the analytical bench. An addendum includes tables on the preparation of buffers and recommended further reading.

Handbook of Capillary Electrophoresis Applications

Author : H. Shintani
Publisher : Springer Science & Business Media
ISBN 13 : 9400915616
Total Pages : 750 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Handbook of Capillary Electrophoresis Applications by : H. Shintani

Download or read book Handbook of Capillary Electrophoresis Applications written by H. Shintani and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 750 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last decade, high performance Capillary electrophoresis (HPCE) has emerged as a powerful and versatile separation technique that promises to rival high performance liquid chromatography when applied to the separation of both charged and neutral species. The high speed and high separation efficiency which can be attained using any of the various modes of HPCE has resulted in the increased use of the technique in a range of analytical environments. The procedures are, however, still in the early stages of development and several barriers remain to their adoption as the technique of choice for a range of analytical problems. One such barrier is the selection and optimization of the conditions required to achieve reproducible separations of analytes and it is in this area that this new book seeks to give assistance. The book is written by an international team of authors, drawn from both academic and industrial users, and the manufacturers of instruments. At its heart are a number of tables, divided into specific application areas. These give details of published separations of a wide range of archetypal analytes, the successful separation conditions and the matrix in which they were presented. These tables are based on separations reported since 1992 and are fully referenced to the original literature. The tables are supported by discussions of the problems that a particular area presents and the strategies and solutions adopted to overcome them. The general areas covered are biochemistry, pharmaceutical science, bioscience, ion analysis, food analysis and environmental science.

Pharmaceutical Analysis E-Book

Author : David G. Watson
Publisher : Elsevier Health Sciences
ISBN 13 : 0702069884
Total Pages : 598 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Analysis E-Book by : David G. Watson

Download or read book Pharmaceutical Analysis E-Book written by David G. Watson and published by Elsevier Health Sciences. This book was released on 2015-12-24 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now comes with an e-book on StudentConsult. Self-assessment is interactive in the accompanying online e-book. 65 online animations show concepts such as ionization partitioning of drug molecules etc. ~

Handbook of Pharmaceutical Analysis

Author : Lena Ohannesian
Publisher : CRC Press
ISBN 13 : 0824741943
Total Pages : 605 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by : Lena Ohannesian

Download or read book Handbook of Pharmaceutical Analysis written by Lena Ohannesian and published by CRC Press. This book was released on 2001-11-09 with total page 605 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques

Author : James P. Landers
Publisher : CRC Press
ISBN 13 : 1420004956
Total Pages : 1598 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques by : James P. Landers

Download or read book Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques written by James P. Landers and published by CRC Press. This book was released on 2007-12-18 with total page 1598 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its third edition, this bestselling work continues to offer state-of-the-art information on the development and employment of capillary electrophoresis. With special emphasis on microseparations and microfluidics, it features new chapters describing the use of microchip electrophoresis and associated microtechniques, with a focus on the extraordinary breadth of work undertaken to expand CE methodologies in recent years. Enhanced by contributions from leading international experts, the Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques, Third Edition remains a seminal reference for the chemistry, biology, and engineering fields.

NMR Spectroscopy in Pharmaceutical Analysis

Author : Iwona Wawer
Publisher : Elsevier
ISBN 13 : 008095152X
Total Pages : 525 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis NMR Spectroscopy in Pharmaceutical Analysis by : Iwona Wawer

Download or read book NMR Spectroscopy in Pharmaceutical Analysis written by Iwona Wawer and published by Elsevier. This book was released on 2017-07-07 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Capillary Electrophoresis Methods for Pharmaceutical Analysis

Author : George Lunn
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 1584 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Capillary Electrophoresis Methods for Pharmaceutical Analysis by : George Lunn

Download or read book Capillary Electrophoresis Methods for Pharmaceutical Analysis written by George Lunn and published by Wiley-Interscience. This book was released on 2000-02-21 with total page 1584 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary Electrophoresis Techniques for Pharmaceutical Analysis at your fingertips-A complete, up-to-date library. This invaluable database--also available on CD-ROM--gives you fast, easy access to the growing literature on capillary electrophoresis (CE). Nearly 3,000 abstracts from approximately 900 publications make up this comprehensive library, listing CE techniques for the analysis of more than 700 active pharmaceutical compounds. From acarbose to mephobarbital to zopiclone--a number of procedures are grouped together for each compound. Detailed, precise information lets you replicate methods without referring to original articles as well as customize methods for specific needs. Features include: * Methods for drugs in biological fluids such as blood or urine as well as for bulk and formulated drugs * Name and structure of each target compound as well as molecular weight and formula, CAS registry numbers, and Merck index number * Experimental conditions for each method, including sample preparation, analytical matrix, capillary/capillary instrument model, capillary temperature, interfering compounds, and more * Bibliography of reviews of capillary electrophoresis procedures The CD-ROM additionally combines the four-volume HPLC Methods for Pharmaceutical Analysis with thousands of methods listed for more than 1,300 compounds. This immensely useful reference will save you countless hours of online and library research.

Pharmaceutical Analysis for Small Molecules

Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 211 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Chromatographic Analysis of Pharmaceuticals

Author : John A. Adamovics
Publisher : Routledge
ISBN 13 : 1351460854
Total Pages : 542 pages
Book Rating : 4.3/5 (514 download)

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Book Synopsis Chromatographic Analysis of Pharmaceuticals by : John A. Adamovics

Download or read book Chromatographic Analysis of Pharmaceuticals written by John A. Adamovics and published by Routledge. This book was released on 2017-09-29 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.

Chiral Capillary Electrophoresis in Current Pharmaceutical and Biomedical Analysis

Author : Peter Mikuš
Publisher : BoD – Books on Demand
ISBN 13 : 9535106570
Total Pages : 211 pages
Book Rating : 4.5/5 (351 download)

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Book Synopsis Chiral Capillary Electrophoresis in Current Pharmaceutical and Biomedical Analysis by : Peter Mikuš

Download or read book Chiral Capillary Electrophoresis in Current Pharmaceutical and Biomedical Analysis written by Peter Mikuš and published by BoD – Books on Demand. This book was released on 2012-08-29 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: The scientific monograph by the author Peter Mikus entitled "Chiral Capillary Electrophoresis in Current Pharmaceutical and Biomedical Analysis" provides a comprehensive view on the advanced capillary electrophoresis techniques aimed to current chiral bioanalysis. The advances in the chiral electrophoresis analytical approaches are divided and theoretically described in three sections involving (i) advanced chiral separations for the optimization of chiral resolution (separation mechanisms; electrophoresis techniques in capillary and microchip format; electrophoretic modes such as ITP, CZE/EKC, CEC; chiral additives / pseudophases / phases), (ii) advanced sample preparation for the on-line preconcentration, sample clean-up and analyte derivatization (implementation of electrophoretic effects such as stacking; non-electrophoretic effects such as SPE, chromatography, dialysis; combinations of these effects; multidimensional CE systems; instrumental schemes), (iii) advanced combinations of detection and electrophoresis for the optimization in qualitative and quantitative evaluation (the most important universal as well as selective detection approaches such as absorption and fluorescence spectrophotometry, electrochemical detection, mass spectrometry vs. (i) and/or (ii)). Real analytical potential (benefits and limitations) of these advanced analytical approaches is emphasized by selected performance parameters of the methods and illustrated by many current practical applications including chiral analyses of drugs, their (bio)degradation products and biomarkers in pharmaceutical and biological matrices. The author wishes the readers many inspirations in the creation of new innovative approaches in the field of advanced chiral electrophoresis techniques with the aim to overcome capabilities of the current analytical techniques.

Capillary Electrophoresis of Proteins and Peptides

Author : Mark A. Strege
Publisher : Springer Science & Business Media
ISBN 13 : 159259798X
Total Pages : 340 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Capillary Electrophoresis of Proteins and Peptides by : Mark A. Strege

Download or read book Capillary Electrophoresis of Proteins and Peptides written by Mark A. Strege and published by Springer Science & Business Media. This book was released on 2008-02-04 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Throughout the more than 20 years that have followed the beginnings of capillary electrophoresis (CE), its application to the analysis of proteins and peptides has continued to be reliable, versatile, and productive. Over time, CE has matured to become a superb complement to HLPC, and in many cases has also evolved as an automated and quantitative replacement for conventional slab gel electrophoresis methods such as SDS-PAGE and isoelectric focusing. Within Capillary Electrophoresis of Proteins and Peptides, we have assembled contributions from researchers who are applying state-of-the-art CE for protein and peptide analysis, including topics that we believe are of great potential both in the present and for the future. In comparison to traditional separation methods, CE represents a miniaturized analysis technique (especially in its microchip-based format) that is highly dependent upon the basic fundamentals of effective sample recovery and high sensitivity detection. With these issues in mind, Chapters 1–4 describe recently developed approaches for both capillary coatings and analyte detection via laser-induced fluorescence. Since the discipline of biotechnology has established itself as a primary platform for the application of CE to the analysis of proteins and peptides, Chapters 5–7 demonstrate a variety of examples of the specific techniques that have been applied for the development of biopharmaceuticals and their commercialization. The methods covered here include also the analysis of oligosaccharides from glycoproteins.

Chemometric Methods in Capillary Electrophoresis

Author : Grady Hanrahan
Publisher : John Wiley & Sons
ISBN 13 : 0470530189
Total Pages : 460 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Chemometric Methods in Capillary Electrophoresis by : Grady Hanrahan

Download or read book Chemometric Methods in Capillary Electrophoresis written by Grady Hanrahan and published by John Wiley & Sons. This book was released on 2009-10-22 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Use chemometric techniques to develop optimum separation conditions for capillary electrophoreses For all its advantages, capillary electrophoresis (CE) also carries significant disadvantages for the researcher. Offering a unique blend of information from authors active in a variety of developments of chemometrics in CE, Chemometric Methods in Capillary Electrophoresis presents modern chemometric methods as an alternative to help alleviate the problems commonly encountered during routine analysis and method development. Focusing on current chemometric methods utilized in CE endeavours by research-active experts in the field, the book begins with a thorough introduction to CE and chemometric-related concepts and the need for modern chemometric methods in CE. Part 1 discusses differing types of screening designs and response surface methodology¿in an¿application based format Part 2 includes vital discussion on various exploratory data analysis, prediction, and classification techniques utilized in CE-related studies Part 3 provides practical information on modelling quantitative structure relationships Part 4 explores transformation techniques, in particular fundamental studies and applications of cross-correlation and Hadamard Transform Electrophoresis Showing how chemometric methods are applied in a wide array of applications including biological, medical, pharmaceutical, food, forensic, and environmental science, Chemometric Methods in Capillary Electrophoresis is not only highly significant to capillary electrophoresis-based endeavours, but instructive for investigators active in other areas of separation science who could benefit from its informative content.

Analytical Method Validation and Instrument Performance Verification

Author : Chung Chow Chan
Publisher : John Wiley & Sons
ISBN 13 : 047146371X
Total Pages : 320 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Analytical Method Validation and Instrument Performance Verification by : Chung Chow Chan

Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.