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Analytical Method Development and Validation » (1st Edition)
Authors: Michael E. Swartz (Editor), Ira S. Krull, Swartz Swartz, Michael Swartz (Editor), Ira S. Krull
ISBN-13: 9780824701154, ISBN-10: 0824701151
Format: Paperback
Publisher: Taylor & Francis, Inc.
Date Published: January 1997
Edition: 1st Edition
Author Biography: Michael E. Swartz
Book Synopsis
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.
Analyst
...a useful primer-type book covering validation of analytical methods. ...recommended.
Table of Contents
| Preface | 3 | |
| Tables and Figures | 11 | |
| Abbreviations | 13 | |
| 1 | Introduction | 17 |
| 2 | Method Development, Optimization, and Validation Approaches | 25 |
| 3 | Method Validation (USP/ICH) | 53 |
| 4 | System Suitability | 73 |
| 5 | Method Validation Protocol | 75 |
| 6 | Method Transfer and Revalidation | 81 |
| 7 | Summary and Conclusions | 83 |
| Bibliography | 85 |
Subjects
Science & Nature
Chemistry Analytical Chemistry - Chromatography
Science & Nature Physics Physics of Light - Spectrum Analysis
Science & Nature All Science & Nature Chemistry - General and miscellaneous
Science & Nature All Science & Nature Physics
Nonfiction Science & Nature Chemistry
Nonfiction Science & Nature Physics
Nonfiction Science & Nature All Science & Nature
Chemistry Analytical Chemistry - ChromatographyScience & Nature
Physics Physics of Light - Spectrum AnalysisScience & Nature
All Science & Nature Chemistry - General and miscellaneousScience & Nature
All Science & Nature PhysicsNonfiction
Science & Nature ChemistryNonfiction
Science & Nature PhysicsNonfiction
Science & Nature All Science & Nature