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Title HPLC Method Development for Pharmaceuticals.

Imprint Academic Pr, 2007.

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Location Call No. OPAC Message Status
 Axe Elsevier ScienceDirect Ebook  Electronic Book    ---  Available
Description 1 online resource
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Summary 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. * Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory * Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) * Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase.
Contents 1. Overview (Satinder Ahuja). -- 2. HPLC Theory (Y.V. Kazakevich). -- 3. HPLC Columns and Packings (U.D. Neue <IT>et al</IT>.). -- 4. Column Characterization and Selection (D. Visky). -- 5. Chiral Separations (Xiande Wang <IT>et al</IT>.). -- 6. Contemporary Liquid Chromatographic Systems for Method Development (M. Swartz). -- 7. Hyphenated Techniques (D.L. Norwood <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 17. Troubleshooting HPLC Methods (H. McNair). -- 18. Molecularly Imprinted Polymers as Sorbents for Separations and Extractions (M.T. Koesdjojo <IT>et al</IT>.).
Note Print version record.
Subject High performance liquid chromatography -- Methodology.
Drugs -- Analysis.
Drug development.
Pharmaceutical Preparations -- analysis
Chemistry, Pharmaceutical -- methods
Chromatography, High Pressure Liquid -- methods
Chromatographie en phase liquide ŕ hautes performances -- Méthodologie.
Médicaments -- Analyse.
Médicaments -- Développement.
Drug development
Drugs -- Analysis
High performance liquid chromatography -- Methodology
Other Form: Print version: HPLC Method Development for Pharmaceuticals. Academic Pr, 2007 9780123705402 0123705401 (OCoLC)144220768
ISBN 9780123705402
0123705401
Standard No. AU@ 000061146603
CHDSB 005986254
DEBBG BV039835230
DEBBG BV042312169
DEBSZ 405301898
NZ1 11778233
NZ1 15194080

 
    
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