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Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes.

Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 107.Publisher: New York : Marcel Dekker, [2000]Copyright date: ©2000Edition: Third edition, revised and expandedDescription: vii, 773 pages. : Illustrations ; 26 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 0824703766 (alk. paper)
Subject(s): DDC classification:
  • 615.1901 21 D
LOC classification:
  • RS424 .C37 2000
Online resources:
Contents:
Introductory overview -- Solution kinetics -- Kinetic pH profiles -- Oxidation in solution -- Catalysis, complexation, and photolysis -- Solid state stability -- Interactions of moisture with solids -- Physical characteristics of solids -- Performulation -- Physical testing -- Development and validation of HPLC stability-indicating assays -- Stability testing of clinical trial materials -- A rational approach to stability testing and analytical development for NCE, drug substance, and drug products : marketed product stability testing -- Packaging, package evaluation, stability, and shelf-life -- Industrial stability testing in the United States and computerization of stability data -- Stability of polypeptides and proteins -- Regulatory aspects of stability testing in Europe -- Regulatory and scientific aspects of stability testing : present and possible future trends -- Appn. : Guidance for industry : stability testing of drug substances and drug products (draft).
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Holdings
Item type Current library Collection Call number Status Date due Barcode
Books Books Main library A11 Pharmacy ( Pharmaceutical Technology ) 615.1901 D (Browse shelf(Opens below)) Available 00016395
Books Books Main library A11 Pharmacy ( Pharmaceutical Technology ) 615.1901 D (Browse shelf(Opens below)) Available 00000694

Previous editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability.

Includes bibliographical references and indexes.

Introductory overview --
Solution kinetics --
Kinetic pH profiles --
Oxidation in solution --
Catalysis, complexation, and photolysis --
Solid state stability --
Interactions of moisture with solids --
Physical characteristics of solids --
Performulation --
Physical testing --
Development and validation of HPLC stability-indicating assays --
Stability testing of clinical trial materials --
A rational approach to stability testing and analytical development for NCE, drug substance, and drug products : marketed product stability testing --
Packaging, package evaluation, stability, and shelf-life --
Industrial stability testing in the United States and computerization of stability data --
Stability of polypeptides and proteins --
Regulatory aspects of stability testing in Europe --
Regulatory and scientific aspects of stability testing : present and possible future trends --
Appn. : Guidance for industry : stability testing of drug substances and drug products (draft).

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