USP Revises Two USP-NF Chapters

USP Revises Two USP-NF Chapters

ROCKVILLE, Md.--The U.S. Pharmacopeia (USP)proposed revisions to two chapters of its National Formulary (USP-NF)affecting dietary supplements. Proposed revisions to General Chapter (2040), Disintegrationand Dissolution of Nutritional Supplements, deal with performancecharacteristics of soft gelatin capsules and adoption of a rupture test fordisintegration. The proposed revision to General Chapter (2091), WeightVariation of Nutritional Supplements, would change the title to Uniformityof Dietary Supplement Intake Units.

"The USP Expert Committees on Dietary Supplements decidedthat content uniformity is a very important attribute for dietary products, fromboth the consumer and good manufacturing practices points of view," saidGabriel Giancaspro, a scientist at USP (www.usp.org).The committees are proposing a hierarchy of index vitamins and minerals todetermine content uniformity. In this approach, combination vitamin/mineralproducts would only have a representative vitamin and mineral analyzed.

USP is accepting comments on the revisions until Feb. 17, 2003.They should be addressed to Gabriel Giancaspro, USP, 12601 Twinbrook Pkwy.,Rockville, MD 20852.