Impurities in Pharmaceutical Industries: A Burning Issue

Abstract

Today, the critical and burning issue in pharmaceutical world is the impurities in bulk drugs and formulations. Nowadays the guidelines for the permissible limits of impurities in either API or any finished products are getting more and more stringent. Even the pharmacopoeial limits for different types of impurities in their monographs of drug substances and drug products are also getting revised every year. Regulatory authorities are demanding the proper documentation for the impurity profiling to ensure the quality of drug product, cosmetics and food ingredients. In this article, we have discussed the types of possible impurities and their sources. We have also listed out the impurity isolation techniques and analytical techniques for the identification, quantification and characterization of impurities.