ABSTRACT
Heavy metal contamination of pharmaceutical components has been a cause for concern for the pharmaceutical industry for many years. Much has changed in the way the pharmaceutical industry has come to think about measuring heavy metals in its components and products in the time since the early 2000s. As modern technology advanced, the need for improvement in the measurement of heavy metals in pharmaceuticals was recognized and called out. From a regulatory perspective, the European Medicines Agency (EMA) began developing a guideline on the control of residual catalysts in pharmaceuticals with the goal of establishing limits based on toxicological safety assessments of common catalytic elements as early as 1998. As with the EMA guideline and the United States Pharmacopeia chapters, the Q3D Expert Working Group tried to set maximum permissible daily exposures for elemental impurities in pharmaceutical products based on an assessment of existing toxicological data for the oral, parenteral, and inhalation routes of administration.
