Validating Chromatographic Methods provides both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications.

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

Contents

1. Overview of Methods Validation
2. Components of Methods Validation
3. Method Evaluation and Further Method Development
4. Final Method Development and Trial Method Validation
5. Formal Method Validation and Report Generation
6. Formal Data Review and Report Issuance

Appendices

• Glossary of Methods Validation Terms
• Template for an Example Methods Validation Standard Operating Procedure (SOP)

Index

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