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Table of Contents
Analytical Method Development And Validation
Preface
Contents
Tables and Figures
Abbreviations
1 Introduction
2 Method Development, Optimization, and Validation Approaches
3 Method Validation (USP/ICH)
4 System Suitability
5 Method Validation Protocol
6 Method Transfer and Revalidation
7 Summary and Conclusions
Bibliography
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ISBN: 0-8247-0115-1
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Copyright © 1997 by MARCEL DEKKER, INC. All Rights Reserved.
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Preface
This book was designed to present and discuss a rationale for the process of essful development
of HPLC-based analytical methods, their optimization, and eventual validation. Although the .
Pharmacopeia (USP) addresses the topic of method validation and although various other sources
cover HPLC method development and optimization on a variety of levels, the literature is
ambiguous regarding the overall formal process that
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combines method development and validation. There are many textbooks on analytical chemistry