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Validating Chromatographic Methods: A Practical Guide
ISBN: 978-0-471-74147-3
Hardcover
304 pages
September 2006
US $84.95 Add to Cart

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  • Description
  • Table of Contents
  • Author Information
  • Reviews
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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