The use of analytical sciences in the discovery, development and manufacture of pharmaceuticals is wide-ranging. From the analysis of minute amounts of complex biological materials to the quality control of the final dosage form, the use of analytical technology covers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drug development and manufacture, focusing on the analysis of the active ingredient or drug substance. It provides those joining...
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...
