IMPURITY PROFILING AND QUALITY BY DESIGN

Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity. There is no clear definition for impurity in the pharmaceutical world. 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. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities as well. The present review covers various aspects related to the analytical method development for impurity profiling of an active pharmaceuticals. Impurity profiling encounters problems in bulk drugs since it assists in enhancing bulk drug quality ultimately benefiting patient.