HPLC Methods for Clinical Pharmaceutical Analysis PDF Download
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Author: Hermann Mascher
Publisher: John Wiley & Sons
ISBN: 3527331298
Category : Science
Languages : en
Pages : 0
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Book Description
Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind
Author: Hermann Mascher
Publisher: John Wiley & Sons
ISBN: 3527331298
Category : Science
Languages : en
Pages : 0
Get Book
Book Description
Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind
Author: Oona McPolin
Publisher: Lulu.com
ISBN: 0956152805
Category : Medical
Languages : en
Pages : 150
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Book Description
If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080554199
Category : Medical
Languages : en
Pages : 532
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Book Description
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: George Lunn
Publisher: Wiley-Interscience
ISBN:
Category : Science
Languages : en
Pages : 2370
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Book Description
Full text included in Knovel Library within the subject area of Chemistry and Chemical Engineering.
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080455181
Category : Medical
Languages : en
Pages : 600
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Book Description
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
Author: George Lunn
Publisher: Wiley-Interscience
ISBN:
Category : Science
Languages : en
Pages : 2370
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Book Description
Full text included in Knovel Library within the subject area of Chemistry and Chemical Engineering.
Author: Quanyun A. Xu
Publisher: American Pharmacists Association (APhA)
ISBN: 9781582121093
Category : Drug stability
Languages : en
Pages : 0
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Book Description
Author: George Lunn
Publisher: Wiley-Interscience
ISBN: 9780471332978
Category : Science
Languages : en
Pages : 0
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Book Description
HPLC and CE Methods for Pharmaceutical Analysis The complete, up-to-date library at the click of a mouse This invaluable database gives you fast, easy access to more than 13,000 abstracts from the current literature on HPLC and capillary electrophoresis (CE). Incorporating the four-volume HPLC Methods for Pharmaceutical Analysis plus the newly introduced Capillary Electrophoresis for Pharmaceutical Analysis, this CD-ROM features an extensive library of methods used in the analysis of most pharmaceutical compounds. It lists available HPLC techniques for more than 1,300 compounds and CE methods for more than 700 compounds, with a number of techniques described for each compound. Detailed, precise information lets you replicate methods without having to refer to the original publications as well as customize methods for very specific needs. You can instantly locate basic compound information--molecular weight and formula, CAS number, and Merck index number--plus experimental conditions for each method. Complex and substructure searching capabilities let you search the entire database by compound, matrix, HPLC variables, and author--saving you countless hours of online or library research. Minimum system requirements: * IBM-compatible PC 486 * Win95 or higher * CD-ROM drive * 8MB RAM * XXXMB free hard disk space Visit us on the Internet: www.wiley.com
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527335633
Category : Medical
Languages : en
Pages : 451
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Book Description
This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.
Author: Oona McPolin
Publisher: Lulu.com
ISBN: 0956152813
Category : Medical
Languages : en
Pages : 154
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Book Description
This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
