New Limits and Procedures for Elemental Impurities in Pharmaceuticals and Dietary Supplements

By Jeff Grindstaff and Colleen Schroeder

Changes to heavy metals test procedures for the analysis of pharmaceuticals and dietary supplements are under review with new standards set to be in place by mid-2013.⁴ The intention of the review is to update current analytical testing historically performed using United States Pharmacopeia (USP) <231>. The revisions (USP<232>, USP<233>, and USP<2232>) are designed to set safer limits for public exposure and to reduce the environmental impact of dated methods. Many in the pharmaceutical industry have concerns about the new instrumentation, more stringent requirements, and the associated costs. Nonetheless, the revisions should have a beneficial impact on the industry by significantly improving specificity and analyte recoveries, as well as by yielding overall time savings resulting in safer, higher quality products.

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For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.

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