Rice Starch

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 26–Sep–2014

Official Date: 01–Aug–2015

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: European Pharmacopoeia

A revision to the harmonized standard for Rice Starch has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 1 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Rice 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:

  • In the beginning of the monograph,
    • Removed the harmonization attributes table and notes. This information is presented in the attached Rice Starch PDG sign-off document.
    • Added “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols to specify this fact.”
  • Identification A
    • Updated the acceptance criteria according to PDG sign-off text. The text was originally published in Stage 4 from PF 30(2).
  • Limit of Sulfur Dioxide
    • Carbon dioxide: changed from “…a flow of 100 ± 10 mL/min” to “…a flow of 100 ± 5 mL/min”
    • Deleted Bromophenol blue indicator solution; updated the Hydrogen peroxide solution preparation and Analysis by using “Bromophenol Blue TS”
    • In Hydrogen peroxide solution preparation, changed concentration of sodium hydroxide from “0.01 N” to “0.1 N”.
  • Microbial Enumeration Tests and Tests for Specified Microorganisms
    • Removed the symbols , since this attribute is harmonized in this revision.

In addition, the monograph has been edited to be consistent with the current USP style guide.

The Rice Starch monograph will be incorporated into and become official with the First Supplement to USP 38–NF 33.

Should you have any questions, 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 Group or contact Emily Meyer (301-230-7438 or eam@usp.org).