Wheat Starch

Type of Posting: 
Notice of Adoption of Harmonized Standard
Posting Date: 
29–Feb–2012
Official Date: 
01–Dec–2012
Expert Committee: 
Monographs—Excipients

A harmonized standard for Wheat Starch has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Wheat Starch monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF monograph include:

  • Updated Carbon Dioxide flow rate in Limit of Sulfur Dioxide test to be consistent with the text in the monograph and sign off text.
  • Eliminated black diamond notation for Microbial Tests, as procedures are now fully harmonized within PDG. 

The Wheat Starch monograph will be incorporated into and become official with the Second Supplement to USP 35–NF 30.

Should you have any questions about the Wheat Starch monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).