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....
Saved in:
Corporate Authors: | |
---|---|
Group Author: | ; |
Published: |
|
Literature type: | Electronic eBook |
Language: | English |
Series: |
Analytical chemistry series
|
Subjects: | |
Online Access: |
http://onlinelibrary.wiley.com/book/10.1002/9780470988749 |
Summary: |
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 a |
Carrier Form: | ix, 275 pages . : illustrations ; 24 cm. |
Bibliography: | Includes bibliographical references and index. |
ISBN: |
9780470988749 0470988746 9780470994221 (electronic bk.) 0470994223 (electronic bk.) |
Index Number: | RS189 |
CLC: | R915 |
Contents: |
Organic impurities in drug substance : 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 of chromatography and online structure elucidation using spectroscopy / Preparative isolation of impurities / The impact of continuous processing / |