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Validating Chromatographic Methods: A Practical Guide
John Wiley and Sons Ltd, Sep 2006, Pages: 304
Validating Chromatographic Methods: A Practical Guide intends to bring order to the potentially chaotic process of methods validation. It provides the novice with enough practical information and tools to keep from having to reinvent the wheel by having to develop their own systems to attach methods validation from scratch. More experienced users can use this guide to upgrade and improve their existing systems. The manual focuses on liquid chromatographic methods validation, because HPLC is the most common analytical technique used in modern pharmaceutical R Standard Test Methods; Methods Validation Protocols (including detailed sample preparation diagrams); Methods Validation Reports; and various other tools and templates. All of this is provided both in print and on a CD-ROM for easy use and modification by the end-user. The book is also an excellent tool for training laboratory personnel in methods validation. After providing an overview of analytical methods validation and the components of methods validation, the book provides whole chapters on each step of validation: initial method evaluation and further development; final method evaluation and trial methods evaluation; formal methods evaluation and report generation; and formal data review and report issuance. All of the information and tools contained in the book will help the user validate a labs methods correctly the first time through the process.
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