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Handbook of analytical validation / Ira S. Krull and Michael Swartz.

By: Contributor(s): Material type: TextTextPublication details: New York : CRC ; London : Taylor & Francis [distributor], 2007.Description: 24 cmISBN:
  • 9780824706890 (hbk.) :
  • 9780824706890 (hbk.) :
Subject(s): DDC classification:
  • 543 SWA
LOC classification:
  • RS189
Contents:
1.Introduction to analytical method validation -- 2.Analytical instrument qualification -- 3.HPLC method development and optimization with validation in mind -- 4.Method validation basics -- 5.Robustness and system suitability -- 6.Setting specifications and investigating out-of-specification results -- 7.Validation by type of method -- 8.Analytical method transfer -- 9.Implementing new technology in a regulated environment.
Summary: Written for both the drug and biotechnology industries, this handbook has been carefully designed to instruct readers as to the current, regulatory requirements to correctly and properly validate a new or modified analytical method.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 543 SWA (Browse shelf(Opens below)) 1 Available 216638

Includes bibliographical references and index.

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

Written for both the drug and biotechnology industries, this handbook has been carefully designed to instruct readers as to the current, regulatory requirements to correctly and properly validate a new or modified analytical method.

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