Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. Impurity profiling has gained importance in modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by selective methods.
Impurities in formulated products and APIs are regulated by various regulatory authorities such as ICH, USFDA, Canadian Drug and Health Agency that are emphasising the purity requirements and the identification of impurities in APIs. Identification, quantification, and control of impurities in API and the drug product are critical in drug development. Organic impurities are often free radicals from by-products, intermediates, or degradation products. Inorganic impurities include transition metals, reagents, and ligands. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques.