First update in a century in testing drugs for elemental impurities

For the first time in more than 100 years, drug and dietary supplement manufacturers are updating the tests used to ensure that their products contain safe levels of metal impurities, and the stringent new requirements, instruments and costs are the topic of the cover story in the current edition of Chemical & Engineering News. C&EN is the weekly newsmagazine of the American Chemical Society, the world's largest scientific society.

Ann Thayer, C&EN senior correspondent, explains that in 1905, the nonprofit standards-setting U.S. Pharmacopeial Convention (USP) first introduced a method for checking medicines for arsenic, mercury and other heavy metals, which can be harmful to health. That same method remains in use today. After almost 20 years of discussion, USP in February published new limits on 15 such impurities and procedures for measuring the levels.

Although implementation has been delayed, makers of the instruments needed for the new tests are working with drug companies to prepare for the new era. Depending on the number of products to be analyzed, drug companies may need to install multiple systems at multiple sites. Some large companies have dozens of sites globally, and each could require one test system that costs up to $150,000.

The article is titled "Trace Metals Debate."