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Fondaparinux Sodium

Type of Posting: Notice of Intent to Revise
Posting Date: 30–Dec–2021
Targeted Official Date: TBD; Revision Bulletin
Expert Committee: Biologics Monographs 3 - Complex Biologics and Vaccines (BIO3)

In accordance with 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 Fondaparinux Sodium monograph.

The BIO3 EC is proposing a revision to the Assay of the Fondaparinux Sodium monograph to specify the use of a new, liquid formulation of the Fondaparinux System Suitability Mixture A Reference Standard.  The new formulation of reference standard is named, Fondaparinux System Suitability Mixture A Solution Reference Standard.  The monograph will be revised in a Revision Bulletin and the official date of the revision will be coordinated with the date when the new Reference Standard is available.  

Should you have any questions, please contact Rebecca Potts, Senior Scientist I (