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), Disintegration
and Dissolution of Nutritional Supplements, deal with performance
characteristics of soft gelatin capsules and adoption of a rupture test for
disintegration. The proposed revision to General Chapter (2091), Weight
Variation of Nutritional Supplements, would change the title to Uniformity
of Dietary Supplement Intake Units.
"The USP Expert Committees on Dietary Supplements decided
that content uniformity is a very important attribute for dietary products, from
both the consumer and good manufacturing practices points of view," said
Gabriel Giancaspro, a scientist at USP (www.usp.org).
The committees are proposing a hierarchy of index vitamins and minerals to
determine content uniformity. In this approach, combination vitamin/mineral
products 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.
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