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Author : Sassan Ghadimi
Publisher :
ISBN 13 :
Total Pages : 182 pages
Book Rating : 4.:/5 (492 download)
Download or read book Validation analytique par Chromatographie Liquide Haute Performance (HPLC) written by Sassan Ghadimi and published by . This book was released on 2004 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.4/5 (822 download)
Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Author : Satish Y. Gabhe
Publisher : diplom.de
ISBN 13 : 3954898071
Total Pages : 108 pages
Book Rating : 4.9/5 (548 download)
Download or read book Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques written by Satish Y. Gabhe and published by diplom.de. This book was released on 2015-08-01 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.
Author : A Fajgelj
Publisher : Royal Society of Chemistry
ISBN 13 : 1847551750
Total Pages : 317 pages
Book Rating : 4.8/5 (475 download)
Download or read book Principles and Practices of Method Validation written by A Fajgelj and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
Author : Lloyd R. Snyder
Publisher : John Wiley & Sons
ISBN 13 : 1118591518
Total Pages : 665 pages
Book Rating : 4.1/5 (185 download)
Download or read book Practical HPLC Method Development written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2012-12-03 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revision brings the reader completely up to date on the evolving methods associated with increasingly more complex sample types analyzed using high-performance liquid chromatography, or HPLC. The book also incorporates updated discussions of many of the fundamental components of HPLC systems and practical issues associated with the use of this analytical method. This edition includes new or expanded treatments of sample preparation, computer assisted method development, as well as biochemical samples, and chiral separations.
Author : David M. Bliesner
Publisher : John Wiley & Sons
ISBN 13 : 0470042192
Total Pages : 301 pages
Book Rating : 4.4/5 (7 download)
Download or read book Validating Chromatographic Methods written by David M. Bliesner and published by John Wiley & Sons. This book was released on 2006-09-11 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.
Author : Chung Chow Chan
Publisher : John Wiley & Sons
ISBN 13 : 047146371X
Total Pages : 320 pages
Book Rating : 4.4/5 (714 download)
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.
Author : Serban C. Moldoveanu
Publisher : Elsevier
ISBN 13 : 0128037113
Total Pages : 600 pages
Book Rating : 4.1/5 (28 download)
Download or read book Selection of the HPLC Method in Chemical Analysis written by Serban C. Moldoveanu and published by Elsevier. This book was released on 2016-11-01 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Selection of the HPLC Method in Chemical Analysis serves as a practical guide to users of high-performance liquid chromatography and provides criteria for method selection, development, and validation. High-performance liquid chromatography (HPLC) is the most common analytical technique currently practiced in chemistry. However, the process of finding the appropriate information for a particular analytical project requires significant effort and pre-existent knowledge in the field. Further, sorting through the wealth of published data and literature takes both time and effort away from the critical aspects of HPLC method selection. For the first time, a systematic approach for sorting through the available information and reviewing critically the up-to-date progress in HPLC for selecting a specific analysis is available in a single book. Selection of the HPLC Method in Chemical Analysis is an inclusive go-to reference for HPLC method selection, development, and validation. - Addresses the various aspects of practice and instrumentation needed to obtain reliable HPLC analysis results - Leads researchers to the best choice of an HPLC method from the overabundance of information existent in the field - Provides criteria for HPLC method selection, development, and validation - Authored by world-renowned HPLC experts who have more than 60 years of combined experience in the field
Author : M. Yoshioka
Publisher : VSP
ISBN 13 : 9789067641135
Total Pages : 316 pages
Book Rating : 4.6/5 (411 download)
Download or read book Supercritical Fluid Chromatography And Micro-hplc written by M. Yoshioka and published by VSP. This book was released on 1989 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1988. Routledge is an imprint of Taylor & Francis, an informa company.
Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080554199
Total Pages : 533 pages
Book Rating : 4.0/5 (85 download)
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
Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 142001448X
Total Pages : 218 pages
Book Rating : 4.4/5 (2 download)
Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Author : George Lunn
Publisher : John Wiley & Sons
ISBN 13 : 0471711675
Total Pages : 743 pages
Book Rating : 4.4/5 (717 download)
Download or read book HPLC Methods for Recently Approved Pharmaceuticals written by George Lunn and published by John Wiley & Sons. This book was released on 2005-05-06 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods
Author : Gabor Patonay
Publisher : Wiley-VCH
ISBN 13 :
Total Pages : 210 pages
Book Rating : 4.3/5 (91 download)
Download or read book HPLC Detection written by Gabor Patonay and published by Wiley-VCH. This book was released on 1992 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gábor Szepesi
Publisher : Wiley-VCH
ISBN 13 :
Total Pages : 376 pages
Book Rating : 4.3/5 (91 download)
Download or read book How to Use Reverse-phase HPLC written by Gábor Szepesi and published by Wiley-VCH. This book was released on 1992 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Henri Colin
Publisher :
ISBN 13 :
Total Pages : 598 pages
Book Rating : 4.:/5 (321 download)
Download or read book A Guide to the HPLC Literature written by Henri Colin and published by . This book was released on 1984 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Vijay Ram
Publisher : GRIN Verlag
ISBN 13 : 365686313X
Total Pages : 81 pages
Book Rating : 4.6/5 (568 download)
Download or read book Development and validation of HPLC method for simultaneous quantitative determination of Azilsartan medoxomil potassium and Chlorthalidone in human plasma written by Vijay Ram and published by GRIN Verlag. This book was released on 2014-12-17 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: Doctoral Thesis / Dissertation from the year 2014 in the subject Chemistry - Analytical Chemistry, grade: 3, Saurashtra University (Department of Chemistry), course: Ph.D., language: English, abstract: The objective of this work was to develop a simple, cost effective, rugged and a high throughput method for simultaneous estimation of Azilsartan and Chlorthalidone in human plasma. Solid phase extraction technique is introduced here for first time and its advantages are: (I) Short processing time, (II) Significant reduction in the labour and (III) This technique minimizes chances of errors, saves considerable time and simplifies the sample preparation methodology. The run time per sample analysis of 15.0 min suggests the high throughput of the proposed method. From the results of all the validation parameters, the method proposed here can be useful for therapeutic drug monitoring both for analysis of routine samples of single dose or multiple dose pharmacokinetics and also for the clinical trial samples.
Author : Mukesh Maithani
Publisher : Springer
ISBN 13 : 9811387230
Total Pages : 101 pages
Book Rating : 4.8/5 (113 download)
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.
