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Z730157 Sigma

Validating Chromatographic Methods: A Practical Guide

D. Bliesner, John Wiley & Sons, 2006, 304 pp., hard cover/CD-ROM

  •  ISBN-13 978-0-471-74147-3

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Description

General description

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 CD-ROM, enabling readers to easily work with and customize them.

Table of Contents

Preface.
1. Overview of Methods Validation.
2. Components of Methods Validation.
3. Step 1: Method Evaluation and Further Method Development.
4. Step 2: Final Method Development and Trial Method Validation.
5. Step 3: Formal Method Validation and Report Generation.
6. Step 4: Formal Data Review and Report Issuance.
Summary.
Appendices.
I. Glossary of Methods Validations Terms.
II. Template for an Example Methods Validation Standard Operating Procedure (SOP).
III. Template for an Example End-User Requirements Questionaire.
IV. Template for an Example Method Review Checklist.
V. Template for an Example Standard Test Method.
VI. Template for an Example Methods Validation Protocol.
VII. Template for an Example Methods Validation Report.
References.
Index.

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