Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30-Apr-2021
Official Date: 01-May-2022
Expert Committee: Complex Excipients
Coordinating Pharmacopeia: European Pharmacopeia
A revision to the 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 4 of the PDG process, the Wheat 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:
- Identification test C. To align the current USP-NF monograph with the PDG sign-off document, change the acceptance criteria from "An orange-red to dark blue color is produced..." to "A dark blue color is produced...".
- Total Protein The current method in the USP-NF monograph is using selenium as decomposition accelerator with sulfuric acid. Due to hazard concern of selenium, it is proposed to replace selenium with titanium dioxide in the catalyst mixture. Based on laboratory data provided by PDG, the test procedure has been modified accordingly.
- Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Wheat Starch monograph will be incorporated into and become official with the USP-NF 2022 Issue 1 (May 1, 2022).
Should you have any questions about the Wheat Starch monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or email@example.com). For any questions about the PDG and its processes, contact Richard Lew at (240-221-2060 or firstname.lastname@example.org).
The previous PDG sign-off Cover Pages and Stage 4 postings are included as below:
- Download the Wheat Starch monograph–Stage 4
- Download the Wheat Starch PDG Sign-Off Documents:
- Previous Stage 4 (formal Stage 6) postings: