Analysis of Drug Impurities / Edition 1

Analysis of Drug Impurities / Edition 1

by Michael L. Webb
     
 

ISBN-10: 1405133589

ISBN-13: 9781405133586

Pub. Date: 04/28/2007

Publisher: Wiley

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

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Overview

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.

Product Details

ISBN-13:
9781405133586
Publisher:
Wiley
Publication date:
04/28/2007
Series:
Sheffield Analytical Chemistry Series, #10
Pages:
288
Product dimensions:
6.10(w) x 9.30(h) x 0.80(d)

Related Subjects

Table of Contents

1. Organic impurities in drug substances: origin, control and measurement.

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2. Organic impurities in drug products: origin, control and measurement.

3. Stereochemical impurities.

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4. Low level measurement of potent toxins.

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5. A systematic approach to impurity identification.

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6. The use chromatography and on-line structural elucidation using spectroscopy .

7. Preparative isolation of impurities.

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8. Impact of continuous processing.

References.

Index

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