Standards-Setting Activities of USP's Council of Experts - Pharmaceutical Technology

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Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.


Pharmaceutical Technology
Volume 35, Issue 3, pp. 78-88

Dietary Supplements Compendium: Dietary Supplements Expert Committee

The Dietary Supplements Expert Committee revises monographs and general chapters that appear in the Dietary Supplements section of USP-NF and, with additional authorized material, in a line extension named the USP Dietary Supplements Compendium.

Members of the Dietary Supplements Expert Committee participate in a variety of joint subcommittees with the General Chapters Expert Committees to develop general chapters for dietary supplements.

  • One joint subcommittee is preparing key revisions to Disintegration and Dissolution of Dietary Supplements <2040>, including the addition of a new dissolution test for soft gelatin capsules containing folic acid in multi-vitamin combinations and riboflavin as an index for water-soluble vitamins. The subcommittee also is developing dissolution standards for fat-soluble vitamins. A new dissolution test for Vitamin A has been proposed and reviewed by the joint subcommittee. A third initiative will update this chapter to address enteric-coated capsules.
  • An ongoing activity with the Chemical Analysis Expert Committee is the new chapter Elemental Contaminants in Dietary Supplements <2232>.
  • Another joint initiative of the Dietary Supplements Expert Committee with the General Chapters—Chemical Analysis is the update of the chapters for vitamin analysis.
  • The expert committee also is creating standards for the detection of economically motivated adulteration, which possibly may have applications for drugs and dietary ingredients.
  • The plan for this cycle also includes the expansion of Supplemental Information for Articles of Botanical Origin <2030>, an update of microbial limits for dietary supplements (three chapters will be affected), and the creation of a new chapter for the detection of irradiation of dietary ingredients.

Monographs:

  • The Expert Committee will update the USP Dietary Supplement Compendium, scheduled for 2012, and future revision will follow. The Expert Committee is reviewing the new information, including an expanded photographic and chromatograms section, 50 new monographs for dietary supplements and dietary ingredients, a new section on excipients used in the manufacture of dietary supplements, a traditional medicines standards reference table, and others.
  • The Expert Committee has renewed interest in traditional medicines monographs and cooperation with Chinese and Indian pharmacopeias to jointly develop harmonized quality standards for ingredients with uses in dietary supplements and traditional medicines.
  • Key initiatives in this cycle include new monograph development and modernization of monographs to replace outdated tests or procedures with updated methodology and to add critical quality tests such as identification tests and tests for contaminants.


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