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Workshop on Metals in Pharmaceuticals and Dietary Supplements

April 28 – 29, 2009
USP Headquarters, Rockville, Maryland

Overview

Metal impurities tests have been available in the United States Pharmacopeia—National Formulary for many years. These tests include the general heavy metals screening tests contained in General Chapter <231> Heavy Metals, as well as specific tests for aluminum, arsenic, iron, lead, mercury and selenium. The screening tests in <231> are non-element-specific limit tests and apply to a relatively small number of elements.

The purpose of the Metal Impurities Workshop is to engage in dialog to develop new approaches for metal impurities in pharmaceuticals and dietary supplements, including methodologies and toxicological limits. These new approaches are intended to replace the existing methods in General Chapter <231> Heavy Metals. This public workshop will seek constructive input from a wide range of stakeholders and seek common ground on general approaches to the standard. The workshop topics will cover: Definition and Scope of the Metal Impurities Activities, Metal Impurity Toxicology Limits, Metal Impurity Methodology and Risk Assessment and Implementation.

The format of this USP Workshop includes an interactive general session dialog on the each of the topics, then breakouts to further explore the issues. Each breakout session will have a reporting activity, followed by interactive discussion. A final session will assimilate all information gathered from the interactive general sessions and breakout sessions.

Presentations

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.

Background Documents

Agenda

Click here  (41KB) for the most up-to-date workshop agenda (as of April 22, 2009)

Contact Information

For additional information or support regarding this workshop, email .