11.01.02
In its September-October 2002 Pharmacopeial Forum (PF), the United States Pharmacopeia (USP), Rockville, MD, stated it is seeking final public comments on revisions made to 14 dietary supplement monographs. These revised monographs are scheduled to be official in the second supplement of the United States Pharmacopeia 26 and National Formulary 21 (USP 26-NF 21). The monographs appear in the “In-Process Revision” section of the PF. This is an opportunity to provide comments before the monographs are published in the USP-NF. For botanical monographs, USP is seeking public comment on black cohosh, powdered black cohosh, powdered black cohosh extract and black cohosh tablets. For nutritional supplement monographs, USP is seeking public comment on aspartic acid, calcium carbonate, mineral capsules, mineral tablets, oil and water soluble vitamin tablets, oil and water soluble vitamins with minerals capsules, oil and water soluble vitamins with minerals tablets, oil soluble vitamin tablets, water soluble vitamins with mineral capsules and water soluble vitamins with minerals tablets.
USP also proposed in its September-October 2002 PF 28 (5) revisions to the General Chapters <2040> “Disintegration and Dissolution of Nutritional Supplements” and <2091> “Weight Variation of Nutritional Supplements” in the USP-NF. 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. 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 Supplements Intake Units.” The requirement for weight variation is currently the only official USP standard for uniformity of nutritional supplements units.
USP also proposed in its September-October 2002 PF 28 (5) revisions to the General Chapters <2040> “Disintegration and Dissolution of Nutritional Supplements” and <2091> “Weight Variation of Nutritional Supplements” in the USP-NF. 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. 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 Supplements Intake Units.” The requirement for weight variation is currently the only official USP standard for uniformity of nutritional supplements units.