Smith / Webb Analysis of Drug Impurities

1. Auflage 2008
ISBN: 978-0-470-99422-1
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 288 Seiten, E-Book

Reihe: Sheffield Analytical Chemistry Series

A key component of the overall quality of a pharmaceutical iscontrol of impurities, as their presence, even in small amounts,may affect drug safety and efficacy. The identification andquantification of impurities to acceptable standards presents asignificant challenge to the analytical chemist. Analytical scienceis developing rapidly and provides increasing opportunity toidentify the structure, and therefore the origin and safetyimplications of these impurities, and the challenges of theirmeasurement drives the development of modern quantitative methods.
Written for both practicing and student analytical chemists,Analysis of Drug Impurities provides a detailed overview ofthe challenges and the techniques available to permit accurateidentification and quantification of drug impurities.

Autoren/Hrsg.

Smith, Richard J.

Webb, Michael L.

Inhaltsverzeichnis

1. Organic impurities in drug substances: origin, control andmeasurement.
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2. Organic impurities in drug products: origin, control andmeasurement.
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 elucidationusing spectroscopy .
7. Preparative isolation of impurities.
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8. Impact of continuous processing.
References.
Index

Über Autor(innen)

Richard Smith is Director, Analytical Sciences atGlaxoSmithKline Research and Development, Tonbridge, UK andMichael Webb is Director, Analytical Sciences atGlaxoSmithKline 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