Handbook of analytical validation / Ira S. Krull and Michael Swartz.
Material type: TextPublication details: New York : CRC ; London : Taylor & Francis [distributor], 2007.Description: 24 cmISBN:- 9780824706890 (hbk.) :
- 9780824706890 (hbk.) :
- 543 SWA
- RS189
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.