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Handbook of analytical validation [electronic resource] / Michael E. Swartz, Ira S. Krull.

By: Contributor(s): Material type: TextPublication details: Boca Raton, Fla. : CRC Press, 2012.Description: xiv, 206 p. : illISBN:
  • 9781420014488 (ebook : PDF)
Subject(s): Genre/Form: Additional physical formats: No titleOnline resources: Available additional physical forms:
  • Also available in print edition.
Contents:
ch. 1. Introduction to analytical method validation -- ch. 2. Analytical instrument qualification -- ch. 3. HPLC method development and optimization with validation in mind -- ch. 4. Method validation basics -- ch. 5. Robustness and system suitability -- ch. 6. Setting specifications and investigating out-of-specification results -- ch. 7. Validation by type of method -- ch. 8. Analytical method transfer -- ch. 9. Implementing new technology in a regulated environment.
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Includes bibliographical references and index.

ch. 1. Introduction to analytical method validation -- ch. 2. Analytical instrument qualification -- ch. 3. HPLC method development and optimization with validation in mind -- ch. 4. Method validation basics -- ch. 5. Robustness and system suitability -- ch. 6. Setting specifications and investigating out-of-specification results -- ch. 7. Validation by type of method -- ch. 8. Analytical method transfer -- ch. 9. Implementing new technology in a regulated environment.

Also available in print edition.

Mode of access: World Wide Web.

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