Validating Chromatographic Methods
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Validating Chromatographic Methods
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Author : David M. Bliesner
language : en
Publisher: John Wiley & Sons
Release Date : 2006-09-11
Validating Chromatographic Methods written by David M. Bliesner and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-09-11 with Science categories.
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.
Validating Chromatographic Methods
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Author : David M. Bliesner
language : en
Publisher: Wiley-Interscience
Release Date : 2006-09-14
Validating Chromatographic Methods written by David M. Bliesner and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-09-14 with Science categories.
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.
Chromatographic Methods In Clinical Chemistry And Toxicology
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Author : Roger Bertholf
language : en
Publisher: John Wiley & Sons
Release Date : 2007-01-30
Chromatographic Methods In Clinical Chemistry And Toxicology written by Roger Bertholf and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-30 with Science categories.
This book aims to fill the gap that exists between theoretical treatments of chromatography, and clinical chemistry and toxicology texts, which focus almost exclusively on clinical relevance and applications. Chromatography has a vast array of clinical applications, and though the chromatographic methods were first introduced decades ago, new applications of this technology are being used to explore previously inaccessible frontiers in clinical diagnostics and toxicological testing. An up-to-date book devoted to clinical and toxicological applications of chromatographic methods will serve as an instructional and reference text, useful to students, laboratory technicians, and researchers.
Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations Hplc And Hptlc Techniques
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Author : Satish Y. Gabhe
language : en
Publisher: diplom.de
Release Date : 2015-08-01
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 has been published by diplom.de this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-01 with Science categories.
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.
Principles And Practices Of Method Validation
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Author : Aleš Fajgelj
language : en
Publisher: Royal Society of Chemistry
Release Date : 2000
Principles And Practices Of Method Validation written by Aleš Fajgelj and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Science categories.
Analytical chemists and representatives of government agencies, standards organizations, and accreditation bodies involved in method validation gathered for an international workshop in November 1999 in Budapest to share experiences and work towards developing guidelines for validating analytical methods in general and specifically for determining pesticide and veterinary drug residues in food. The 18 lectures include discussions of validating analytical data in a research and development environment, the effects of sample processing on pesticide residues in fruits and vegetables, estimating the significance of matrix-induced chromatographic effects, and a worked example for validating a multi-residue method. Annotation copyrighted by Book News, Inc., Portland, OR
Hplc For Pharmaceutical Scientists
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Author : Yuri V. Kazakevich
language : en
Publisher: John Wiley & Sons
Release Date : 2007-02-16
Hplc For Pharmaceutical Scientists written by Yuri V. Kazakevich and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-16 with Science categories.
HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Chromatographic Techniques
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Author : Mr. Rohit Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-04-08
Chromatographic Techniques written by Mr. Rohit Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-08 with Science categories.
Separation methods are covered. Guides students to analyze chromatographic processes, fostering expertise in analytical chemistry through laboratory experiments and theoretical study.
Chromatographic Methods Development
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Author : Gregory K. Webster
language : en
Publisher: CRC Press
Release Date : 2019-10-28
Chromatographic Methods Development written by Gregory K. Webster and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-28 with Medical categories.
This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.
Handbook Of Pharmaceutical Analysis By Hplc
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2005-02-09
Handbook Of Pharmaceutical Analysis By Hplc written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-09 with Medical categories.
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Handbook Of Stability Testing In Pharmaceutical Development
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Author : Kim Huynh-Ba
language : en
Publisher: Springer Science & Business Media
Release Date : 2008-11-16
Handbook Of Stability Testing In Pharmaceutical Development written by Kim Huynh-Ba and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-11-16 with Medical categories.
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.