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. 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. active pharmaceutical ingredient, pharmaceutical analysis, stereochemical impurities, proton reference spectrum, drug impurities, stereoisomeric impurities, cryogenic flow probe, drug substance impurities, impurity identification, transient diastereomeric complexes, stereoisomeric purity, genetic toxins, product ion scan, exchangeable hydrogen atoms, cone voltage, new impurity, preparative isolation, product ion spectra, new drug substances, retest date, solvent suppression, chiral selectors, process impurities, active volume, toxic impurities