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Archive for April, 2011

Heavy Metals (USP<231>) Revisions

Tuesday, April 26th, 2011

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

ICP-MSBy 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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