Elemental Impurities

The elemental impurity classes are: Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements ... Read More

In considering the production of a drug product, there are broad categories of potential sources of elemental impurities. The following diagram shows an example of typical materials, equipment and components used in the production of a drug product. Each of these sources may contribute elemental impurities to the drug product, ... Read More