Type of Posting: Notice of Intent to Revise
Posting Date: 30–Jul–2021
Targeted Official Date: 01-May-2023, USP-NF 2023 Issue 1
Expert Committee: Biologics Monographs—Complex Biologics and Vaccines (BIO3)
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monograph—Complex Biologics and Vaccines (BIO3) Expert Committee intends to revise the Dextran 40 Monograph.
The Expert Committee proposes to revise the Molecular Weight Distribution and Weight and Number Average Molecular Weights Section in the Monograph to remove USP Dextran 40 System Suitability RS. The USP Dextran 40 System Suitability RS will be replaced with USP Dextran 40 RS.
It is anticipated that the proposed revision will be published in Pharmacopeial Forum 47(5) [Sep-Oct 2021] pursuant to the Rules and Procedures.
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