Day 1 - US Pharmacopeial Convention

USP Sponsored Workshop at 2010 AAPS-PSWC Meeting
Impurities, Adulteration, and the Changing Role of the USP in Global Drug Quality
November 13-14, 2010
MMorial i l CConvention ti CCenter, t NNew OOrleans, l LA
USP’s Elemental Impurities Initiative – Perspectives and
Current Status
Anthony J. DeStefano, Ph.D.
Vice President, General Chapters, USP
Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World
Background-Issues with Chapter Heavy Metals
� Difficulties in reproducibility
– Monitor solutions, standards, recovery y issues
� Difficulties with reagents – safety issues
– All procedures generate H2S; thioacetamide not allowed in
California and several European countries
� Nondiscriminatory screening test
– Not element specific
– Sensitivity varies by element
– Only a few elements respond at required sensitivities
� Visual comparison test
– Limits based on visual acuity, not toxicology
11/23/2010
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