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Handbook of isolation and characterization of impurities in pharmaceuticals / edited by Satinder Ahuja, Karen Mills Alsante.

Contributor(s): Material type: TextTextSeries: Separation science and technology ; v. 5 | Separation science and technology ; v. 5Publication details: Amsterdam ; London : Academic, 2003.Description: xvi, 414 p. : ill. 27 cmISBN:
  • 9780120449828 (hbk.) :
  • 9780120449828
  • 012044982X
Subject(s): DDC classification:
  • 615.19 AHU
LOC classification:
  • RS189
Contents:
1.Overview: isolation and characterization of impurities -- 2.Review of regulatory guidance on impurities -- 3.Polymorphic and solvatomporphic impurities -- 4.Impurites in drug products -- 5.Strategies for investigation and control of process and degradation-related impurities -- 6.Reference standards -- 7.Sample selection for analytical method development -- 8.Sample preparation methods for the analysis of pharamceutical materials -- 9.Isolation methods I: thin-layer chromatography -- 10.Isolation methods II: column chromatography -- 11.Mass spectral characterization -- 12.NMR characterization of impurities -- 13.Hyphenated characterization techniques -- 14.Solving impurity/degradation problems: case studies.
Summary: Filling the need for a reference text on the complex process of isolating and characterizing process-related impurities and degradation products, this volume describes the techniques and technologies used to meet critical industry regulatory requirements.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 615.19 AHU (Browse shelf(Opens below)) 1 Available 202859

Includes bibliographical references and index.

1.Overview: isolation and characterization of impurities -- 2.Review of regulatory guidance on impurities -- 3.Polymorphic and solvatomporphic impurities -- 4.Impurites in drug products -- 5.Strategies for investigation and control of process and degradation-related impurities -- 6.Reference standards -- 7.Sample selection for analytical method development -- 8.Sample preparation methods for the analysis of pharamceutical materials -- 9.Isolation methods I: thin-layer chromatography -- 10.Isolation methods II: column chromatography -- 11.Mass spectral characterization -- 12.NMR characterization of impurities -- 13.Hyphenated characterization techniques -- 14.Solving impurity/degradation problems: case studies.

Filling the need for a reference text on the complex process of isolating and characterizing process-related impurities and degradation products, this volume describes the techniques and technologies used to meet critical industry regulatory requirements.

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