BRIEFING

 Dextran 40. This proposal is based on the version of the monograph official as of July 1, 2022. The proposal for this drug substance which appeared in PF 47(5) [Sep.–Oct. 2021] has been canceled and is being replaced with this new proposal. On the basis of review by the Biologics Monographs 3—Complex Biologics and Vaccines Expert Committee and on comments received, the following changes are proposed:

1. Add Identification C.

2. In the Molecular Weight Distribution and Weight and Number Average Molecular Weights test, add details for the Column temperature and Flow rate.

3. In the Limit of Alcohol and Related Impurities test, make minor revisions for clarity in the Analysis.

4. Delete the two animal tests, Safety and Antigenic Impurities, from the monograph.

5. Correct the author's name and add the issue number in footnote 1.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (BIO3: Y. Han)

 Case ID—SUB-1013