BRIEFING

 Dextran 70. 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(6) [Nov.–Dec. 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 of comments received, the following changes are proposed:

1. Add the CAS number and UNII code to the Chemical Information section.

2. Add Identification C.

3. In the Limit of Alcohol and Related Impurities test, make a minor revision for clarity in the Acceptance criteria.

4. Incorporate minor editorial changes to the tests for pH and Color of Solution for consistency.

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

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

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

 (BIO3: Y. Han)

 Case ID: SUB-1012