BRIEFING
Fondaparinux Sodium Injection. This proposal is based on the version of the monograph official as of April 1, 2023. Due to the formulation change for USP Fondaparinux Sodium System Suitability Mixture B RS, the Biologics Monographs 3–Complex Biologics and Vaccines Expert Committee proposes to revise the monograph with the following change: Update the USP Fondaparinux Sodium System Suitability Mixture B RS to USP Fondaparinux Sodium System Suitability Mixture B Solution RS in the Assay, Organic Impurities, and USP Reference Standards sections.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BIO3: J. Sun)
Correspondence Number—C322780