Corn Starch

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 22-Nov-2024

Official Date: 01–Dec–2025

Expert Committee: Complex Excipients

Coordinating Pharmacopeia: USP

A revision to the harmonized standard for Corn Starch has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 (former Stage 6) of the PDG process, the Corn Starch monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF monograph include:

  1. Definition. Changed the scientific name from "L." to "Linné” to align with the PDG sign-off document.
  2. Identification A. Changes include the following: 1) revised to include the 24-µm particle size; 2) revised to clarify that regardless of particle size, the particle shape can be angular polyhedral, rounded, or spheroidal granules of irregular sizes.
  3. Limit of Sulfur Dioxide.
    • Carbon Dioxide: Changed from “…a flow of 100 ± 10 mL/min” to “…a flow of 100 ± 5 mL/min” to align with the PDG sign-off document.
    • Analysis: Added “with the color change lasting for at least 20 s” to align with the PDG sign-off document.
  4. Microbial Enumeration Tests is a harmonized attribute. However, it contains a local requirement as indicated in the diamond symbols, "Where it is intended for use in preparing Absorbable Dusting Powder, it also meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa."
    • Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Corn Starch monograph will be incorporated into USP-NF and become official on December 1, 2025.

Should you have any questions about the Corn Starch monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please contact Mr. Richard Lew at (240-221-2060 or rll@usp.org).

The PDG sign-off and Stage 4 postings are included as below: