Type of Posting: Notice of Intent to Revise
Posting Date: 28-Jan-2022; updated 11–Feb–2022; updated 8–Mar–2022
Targeted Official Date: 01-Jul-2022, Revision Bulletin
Expert Committee: Biologics Monographs 3-Complex Biologics and Vaccines (BIO3)
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 3-Complex Biologics and Vaccines (BIO3) Expert Committee intends to revise the Dextran 40 and Dextran 70 monographs.
The Expert Committee proposes the following revisions to the Molecular Weight Distribution and Weight and Number Average Molecular Weights Section in both monographs.
- In the Dextran 40 monograph, replacing the USP Dextran 40 System Suitability RS with USP Dextran 40 RS.
- In Dextran 70 monograph, replace the USP Dextran 70 System Suitability RS with USP Dextran 70 RS.
- Removing the System Suitability molecular weight ranges from the monograph, and adding language to the monograph to direct the user to the reference standard certificate for the ranges.
It is anticipated that the proposed revisions will be published as a Revision Bulletin pursuant to the Rules and Procedures of the Council of Experts. The revisions will be published on March 25, 2022 and become official on July 1, 2022. The previously proposed revisions to Dextran 40 monograph in Pharmacopeial Forum 47(5) [Sep.–Nov. 2021] and Dextran 70 monograph in Pharmacopeial Forum 47(6) [Nov. 2021–Jan. 2022] will be canceled
Should you have any questions, please contact Rebecca Potts, Senior Scientist I (email@example.com).
This Notice was revised on February 11, 2022 to update the anticipated official date and provide additional clarity regarding the changes and on March 8, 2022 to correct the official date in the text of the Notice.