A Review on Metal Impurities in Pharmaceuticals

Abstract

Sources of metal impurities can from anywhere in drug product as raw material which may produce using metal catalyst, excipients, process materials, Water or any solvent used, manufacturing equipment, environment, packaging materials. So, it leads to metal impurity in high amount present in final drug product that is why it is important to check the impurity level in final drug product or as well as in process also that it should be present in low or acceptable amount. Any Drug product is not completely pure, some amount of metal impurities are always present in pharmaceutical product may cause various toxicity when it will be administered. Thus it is necessary to check impurity level is present at acceptable amount. The present review gives an account of updated information about metal impurities and reviews the regulatory aspects for such metal impurities in drug substance/drug product. In addition the aim of this article is to discuss the currently used different analytical techniques for detection of metals from drug product like spectrophotometry, X – Ray florescence spectrometry, AAS, INAA, ICP – AES, ICP – MS, MP – AES, Laser Ablation – ICP – MS etc which is used for quality control of metal impurities in pharmaceuticals.