Analysis of Drug Impurities

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.

Written for both practicing and student analytical chemists, Analysis of Drug Impurities provides a detailed overview of the challenges and the techniques available to permit accurate identification and quantification of drug impurities.

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

"This is a unique book; the editors are to be conrgatulated on persuading their industrial colleagues to write chapters, providing an industrial focus on analytical issues. This is a useful volume which fills a gap in the literature... I would recommend the book to all process and analytical chemists."
Trevor Laird"This book can be recommended to not only analytical chemists but also scientists working in the field of pharmaceutical analysis."
Annals of Bioanalytical Chemistry 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

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.

Written for both practicing and student analytical chemists, Analysis of Drug Impurities provides a detailed overview of the challenges and the techniques available to permit accurate identification and quantification of drug impurities.