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.
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
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