Analysis of Drug Impurities ( Sheffield Analytical Chemistry Series )

Publication series :Sheffield Analytical Chemistry Series

Author: Richard J. Smith  

Publisher: John Wiley & Sons Inc‎

Publication year: 2008

E-ISBN: 9780470994221

P-ISBN(Hardback):  9781405133586

Subject: R917 pharmaceutical analysis

Language: ENG

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Description

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.

Chapter

Preface

pp.:  1 – 13

List of contributors

pp.:  13 – 14

3 Stereochemical impurities

pp.:  35 – 61

4 Low-level measurement of potent toxins

pp.:  61 – 96

5 A systematic approach to impurity identification

pp.:  96 – 138

6 The use of chromatography and online structure elucidation using spectroscopy

pp.:  138 – 170

7 Preparative isolation of impurities

pp.:  170 – 229

8 The impact of continuous processing

pp.:  229 – 249

Index

pp.:  249 – 287

LastPages

pp.:  287 – 290

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