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Elemental Impurities

Revised July 20, 2010

USP proposed the following three new General Chapters on Elemental Impurities Limits, Methods, and Dietary Supplements Metals Limits in the January-February issue of Pharmacopeial Forum (PF 36(1)). Other related information also appeared in PF 36(1), including a draft General Notices statement about the applicability of the standard to all monographs and two Stimuli articles outlining the rationale for the revisions and the comments received from an original Stimuli article and Workshop.


These revisions focus on two areas of work:

  • Updating the methodology used to test for elemental impurities in drugs and dietary supplements to include procedures that rely on modern analytical technology; and
  • Setting limits for acceptable levels of metal impurities (including, but not limited to, lead, mercury, arsenic, and cadmium) in drugs and dietary supplements.

The USP Metal Impurities Expert Panel, which will report to the USP Chemical Analyses Expert Committee in the new USP cycle, worked with USP staff and stakeholders to assess methodologies and limits that provide greater patient/consumer protection and can reasonably be deployed across industry laboratories. The limits for exposure are toxicologically based and developed by an expert consensus process to provide quality standards that reflect consensus views about potential health/toxicity concerns.

These new approaches are intended to replace the existing methods in General Chapter <231> Heavy Metals. Deadline to submit comments to USP ended on April 15, 2010. The USP Metal Impurities Expert Panel is currently reviewing comments and will propose a revision to these chapters in the next available PF. Although the official comment period has ended interested parties are encouraged to submit data at any time to Kahkashan Zaidi, Ph.D., Senior Scientific Liaison, General Chapters, Division of Standards Development. ().

Frequently Asked Questions

Background Documents

Workshop on Metals in Pharmaceuticals and Dietary Supplements (April 28–29, 2009)

Note: The content of these presentations reflects the ideas and suggestions of the participants at the Metal Impurities Workshop, April 28-29, 2009. These deliberations are advisory and are not binding in any way to the Council of Experts, its Expert Committees and Advisory Panels, or USP staff.

Reference Standards

USP intends to develop official USP Reference Standards in support of the revisions for the General Chapter on Metal Impurities. These new USP Reference Standards will provide high quality reference materials designed to help demonstrate compliance with the new chapter on metal impurities.

As the General Chapter evolves through the revision process, the type and number of USP Reference Standards will also need to be developed in USP's Analytical Research and Development laboratory. If you would like to receive email notifications when these new, first time Reference Standards become available, sign up for USP's Reference Standards Release Notification Program. Since there currently is no official USP Reference Standard name in the "Name of Reference Standard(s)" field please type "Metal Impurities".

Download the entire USP Reference Standards Catalog.

USP's Compendial Updates

To keep informed about any Revision Bulletin to General Chapter <231> Heavy Metals, sign up for USP's free Compendial Updates email service.

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Contacts

  • Monographs: Kahkashan Zaidi ( or 301–816–8269)
  • Media: Laura Provan ( or 301–816–8268)
  • Reference Standards Technical Support: RS Technical Service ( or 301–816–8129)
  • Reference Standards Ordering: USP Customer Service ( or 800–227–8772)