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9781405133586

Analysis of Drug Impurities

by ;
  • ISBN13:

    9781405133586

  • ISBN10:

    1405133589

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2007-04-30
  • Publisher: Wiley-Blackwell

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Supplemental Materials

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Summary

The presence of impurities, even in small amounts, may affect the efficacy and safety of pharmaceuticals. The methods for detecting and controlling them are subject to continuous review and improvement. Characterisation of impurities is a crucial aspect of drug development and approval, and is central to quality control. This book provides a source of reference on the techniques available for accurate identification and quantification of drug impurities, and it brings together all the relevant disciplines within one volume for the first time.

Author Biography

Richard Smith is Director, Analytical Sciences at GlaxoSmithKline Research and Development, Tonbridge, UK and Michael Webb is Director, Analytical Sciences at GlaxoSmithKline Research and Development, Stevenage, UK.

Contributors to the book:
Dr Linda Ng
Dr George Lunn
Dr Patrick Faustino
Dr Dave Elder
Dr Mark R. Hadley
Dr Peter Skett
Dr Gary E. Martin
Dr Ian Jones
Dr Janet Hammond
Dr Gerald Terfloth
Dr Frank Cottee

Table of Contents

Organic impurities in drug substances: origin, control and measurement
Organic impurities in drug products: origin, control and measurement
Stereochemical impurities
Low level measurement of potent toxins
A systematic approach to impurity identification
The use chromatography and on-line structural elucidation using spectroscopy
Preparative isolation of impurities
Impact of continuous processing
References
Index
Table of Contents provided by Publisher. All Rights Reserved.

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