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HPLC Method Development for Pharmaceuticals

Record Type:	Electronic resources : Monograph/item
Title/Author:	HPLC Method Development for Pharmaceuticals/
Published:	Academic Pr : 2007.,
Subject:	High performance liquid chromatography - Methodology. -
Online resource:	http://www.sciencedirect.com/science/book/9780123705402
ISBN:	9780123705402

HPLC Method Development for Pharmaceuticals
HPLC Method Development for Pharmaceuticals[electronic resource]. - Academic Pr2007.

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>.).

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.

Electronic reproduction.
Amsterdam :
Elsevier Science & Technology,
2007.

Mode of access: World Wide Web.

ISBN: 9780123705402

Source: 116045:116143Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

322272
High performance liquid chromatography
--Methodology.Index Terms--Genre/Form:

96803
Electronic books.

LC Class. No.: RS189.5.H54 / H65 2007

Dewey Class. No.: 615/.1901

HPLC Method Development for Pharmaceuticals
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505 0 $a 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>.).
520 $a 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.
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