Handbook of modern pharmaceutical analysis / edited by Satinder Ahuja, Stephen Scypinski.

Format:

Book

Contributor:

Ahuja, Satinder, 1933-

Scypinski, Stephen.

Series:

Separation science and technology (San Diego, Calif.) ; v. 10.

Separation science and technology, 0149-6395 ; v. 10

Language:

English

Subjects (All):

Pharmaceutical chemistry--Handbooks, manuals, etc.

Pharmaceutical chemistry.

Drugs--Analysis--Handbooks, manuals, etc.

Drugs.

Physical Description:

1 online resource (604 p.)

Edition:

2nd ed.

Place of Publication:

Amsterdam : Elsevier/Academic Press, 2011.

Language Note:

English

Summary:

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use.Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to itCovers method development, validation,

Contents:

Front Cover; Handbook of Modern Pharmaceutical Analysis; Copyright Page; Contents; Preface; Contributors; Chapter 1: overview of Modern pharmaceutical Analysis; I. Introduction; II. Solid-State Studies; III. Degradation and Impurities Studies; IV. Analytical Considerations for Genotoxic and Other Impurities; V. Quality by Design and Process Analytical Technology; VI. Novel Dosage Forms; VII. Method Development for Chiral Compounds; VIII. Characterization and Analysis of Biopharmaceutical Proteins; IX. Preformulation and Early Phase Method Development; X. In-Process Control Testing

XI. Method ValidationXII. Stability Studies; XIII. Method Transfer; XIV. Documentation; References; Chapter 2: Characterization of pharmaceutical Compounds in the Solid State; I. Introduction; II. Properties Associated with the Molecular Level; III. Properties Associated with the Particulate Level; IV. Properties Associated with the Bulk Level; V. Summary and Conclusions; References; Chapter 3: Degradation and Impurityanalysis for Pharmaceuticaldrug Candidates; I. Forced Degradation Studies; II. Isolation of Impurities/Degradants; III. Mass Spectrometry in the Identification of Impurities

IV. NMRV. Case Studies; VI. Summary; References; Chapter 4: Analytical Considerations for Genotoxic and Other Impurities; I. Introduction; II. Concept of GTI Relative to Standard Impurities and the Current regulatory Thinking; III. Viracept® GTI Contamination Issue; IV. GTI Risk Assessment and Control Strategy Design; V. Analytical Challenges; VI. Summary and Conclusions; Acknowledgments; References; Chapter 5: Quality by Design and Theimportance of Pat in QbD; I. Introduction; II. The Role of Pat in QbD; III. Summary and Considerations Regarding Return on Investment for QbD/PAT; References

Chapter 6: Novel Dosage form AnalysisI. Introduction; II. Tablets; III. Capsule Dosage Forms; IV. Cachet Dosage Forms; V. Sustained Release Dosage Forms; VI. Solution, Suspension, Emulsion, and Parenteral Dosage Forms; VII. Homogenization; VIII. Metered-Dose Inhalers; IX. Conclusions; References; Chapter 7: Method Development for Pharmaceutical Chiralchromatography; I. Introduction; II. Overview of Chiral Separations; III. Commercially Available Chiral Columns for Liquid Chromatography/Supercritical Fluid Chromatography; IV. Commercially Available Chiral Columns for GC

V. Preparative Chiral chromatographyVI. Chiral Method Development Screening; VII. Chiral Detectors for LC/SFC Systems; VIII. Summary and Conclusions; References; Chapter 8: Characterization and Analysis of Biopharmaceutical Proteins; I. Introduction; II. Structure; III. Concentration; IV. Purity; V. Function; VI. Summary and Conclusions; Acknowledgments; References; Chapter 9: Preformulation and Early Phase Method Development; I. Introduction; II. Preformulation API Physicochemical Properties; III. Drug Product; IV. Clinical Dosage Forms; V. Conclusions; References

Chapter 10: In-Process Control Testing

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-282-87902-2

9786612879029

0-12-375981-1

OCLC:

688607756