USP Workshop—Metals in Pharmaceuticals and Dietary Supplements

The aim of the workshop was to gather constructive input on developing new approaches for detecting 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.

Topics:

• Definition and scope of metal impurities activities
• Metal impurity toxicology limits
• Metal impurity methodology
• Risk assessment and implementation

When: April 28–29, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

• General Presentation
• Final Summary Session

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.

Workshop Materials:

• The Digest of Comments Received on the Stimuli Article "General Chapter on Inorganic Impurities: Heavy Metals" Published in Pharmacopeial Forum 34(5)
• The USP Advisory Panel on Metal Impurities "Draft Metals and Limits Table"

Participants: Representatives from the pharmaceutical and dietary supplement industries, regulatory authorities, and consumer groups.