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.
Содержание
1. Organic impurities in drug substances: origin, control and
measurement.
.
2. Organic impurities in drug products: origin, control and
measurement.
3. Stereochemical impurities.
.
4. Low level measurement of potent toxins.
.
5. A systematic approach to impurity identification.
.
6. The use chromatography and on-line structural elucidation
using spectroscopy .
7. Preparative isolation of impurities.
.
8. Impact of continuous processing.
References.
Index
Об авторе
Richard Smith is Director, Analytical Sciences at
Glaxo Smith Kline Research and Development, Tonbridge, UK and
Michael Webb is Director, Analytical Sciences at
Glaxo Smith Kline 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
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