A harmonized standard for Potato 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 Potato 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 acceptance criteria for Identification B to read “a thick opalescent” mucilage is formed consistent with PDG text, and to distinguish between other Starches.
- 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 Potato 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 Potato Starch monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.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 email@example.com).