November 5, 2002
Rockville, Maryland -- The United States Pharmacopeia (USP) has proposed in the September-October 2002 Pharmacopeial Forum 28(5) revisions to the General Chapters <2040> Disintegration and Dissolution of Nutritional Supplements and <2091> Weight Variation of Nutritional Supplements in the United States Pharmacopeia and the National Formulary
USP proposed revisions to General Chapter <2040> Disintegration and Dissolution of Nutritional Supplements because of comments stating that performance characteristics for dietary supplements in soft gelatin capsules are not appropriately measured by the disintegration test. Due to this, USP has adopted a rupture test and decided to publish this proposed revision to the General Chapter <2040> in the PF.
In addition, the intention of the proposed revisions to General Chapter <2091> Weight Variation of Nutritional Supplements is to change the chapter's title to Uniformity of Dietary Supplement Intake Units. The requirement for weight variation is currently the only official USP standard for uniformity of nutritional supplements units.
"We decided to change the chapter's title since content uniformity was not adopted at the time of the current chapter's inception," said Dr. Gabriel Giancaspro, scientist at USP. "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."
To reduce the analytical burden that content uniformity measurement entails, the USP committees are proposing a hierarchy of index vitamins and minerals to determine this property. In this simplified approach, for a combination vitamin/mineral product, only a representative vitamin and mineral are analyzed. This approach represents a significant improvement over using weight variation only. The USP Expert Committees on Dietary Supplements encourage interested parties to submit data along with comments on these proposals to USP.
Comments on the revisions made to the General Chapters should be addressed and mailed by Feb. 17, 2003 to Dr. Gabriel Giancaspro at USP, 12601 Twinbrook Parkway, Rockville, MD 20852. Additional questions pertaining to manufacturing practices for dietary supplements can be e-mailed to [email protected].
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