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| HPLC METHOD DEVELOPMENT FOR PHARMACEUTICALS, 8
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Edited By
Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
Henrik Rasmussen, Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA
Included in series
Separation Science and Technology,
Description
High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring
changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final
drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses
these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC,
column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample
preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC
Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development
chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.
Audience
For researchers, analysts, managers, and regulators of the pharmaceutical industry
Contents
1. Overview (Satinder Ahuja).
2. HPLC Theory (Y.V. Kazakevich).
3. HPLC Columns and Packings (U.D. Neue et al.).
4. Column Characterization and Selection (D. Visky).
5. Chiral Separations (Xiande Wang et al.).
6. Contemporary
Liquid Chromatographic Systems for Method Development (M. Swartz).
7. Hyphenated Techniques (D.L. Norwood et al.).
8. HPLC Sample Preparation (G. Slack, N.H. Snow).
9. Instrument and Software Qualification and Validation (D. Van Geel).
10. Pharmaceutical Development: From Pre-clinical to Post Approval (K. Bynum).
11. HPLC Method Development for Drug Discovery LC-MS
Assays in Rapid PK Applications (Xiaoying Xu, W. Korfmacher).
12. HPLC Method Development in Early Phase Pharmaceutical Development
(H.T. Rasmussen et al.).
13. HPLC Method Development in Late Phase Pharmaceutical Development (M. Ilias Jimidar).
14.
Use of HPLC for In-process Testing (C. Richardson).
15. Method Development for Biomolecules (D.E. Raynie, J.L. Driver).
16. Method
Validation (M. Ilias Jimidar et al.).
17. Troubleshooting HPLC Methods (H. McNair).
18. Molecularly Imprinted Polymers
as Sorbents for Separations and Extractions (M.T. Koesdjojo et al.).
| Bibliographic details |
Hardbound, 532 pages, publication date: MAY-2007
ISBN-13: 978-0-12-370540-2
ISBN-10: 0-12-370540-1
Imprint: ACADEMIC PRESS
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| Price and Ordering |
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USD 260
EUR 189.95
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Last update: 25 Nov 2009
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