Type of Posting: Notice of Intent to Revise
Posting Date: 25-Feb-2022
Targeted Official Date: 01-Jun-2022; Revision Bulletin
Expert Committee: Small Molecules 5
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to revise the Dextrose Injection monograph.
Comments with supporting data were received that the new Sample solution for products that are terminally sterilized in the Assay may not be suitable for all terminally sterilized products. The Expert Committee proposes to revise the Dextrose Injection monograph by removing the new Sample solution for products that are terminally sterilized in the Assay and adding a Note to the original Sample solution stating that “ammonium hydroxide may be omitted for finished products containing up to 10% dextrose that have been terminally heat sterilized”.
It is anticipated that the proposed revision will be published as a Revision Bulletin on May 27, 2022 pursuant to the Rules and Procedures.
Should you have any questions or comments, please contact Mary P. Koleck, Principal Scientist (email@example.com).