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Enoxaparin Sodium, <209> Low Molecular Weight Heparin Molecular Weight Determinations and Dalteparin Sodium

Type of Posting: Notice of Intent to Revise
Posting Date: 28-Jan-2022
Targeted Official Date: 01-Nov-2022, Interim Revision Announcement; 01-Dec-2023, USP-NF 2023, Issue 3
Expert Committee: Biologics Monographs 3-Complex Biologics and Vaccines (BIO3)

In accordance with the 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 Enoxaparin Sodium monograph, General Chapter <209> Low Molecular Weight Heparin Molecular Weight Determinations and Dalteparin Sodium monograph.

The Expert Committee proposes the following revisions:

  1. To revise Identification D in the Enoxaparin Sodium monograph to reference Chapter <209> Low Molecular Weight Heparin Molecular Weight Determinations to align the methodology for low molecular weight heparins. 
  2. To revise Chapter <209> Low Molecular Weight Heparin Molecular Weight Determinations, to modify the mandate of the system suitability solution and Weight average molecular weight (Mw) to make this general chapter suitable for both the Enoxaparin Sodium and Dalteparin Sodium monographs.
  3. To revise Identification B in the Dalteparin Sodium monograph to add the system suitability solution and the requirements for the Weight-average molecular weight (Mw) obtained from the system suitability solution to align with the revisions of <209>.

It is anticipated that the proposed revisions for Enoxaparin Sodium monograph and <209> Low Molecular Weight Heparin Molecular Weight Determinations will be published as Interim Revision Announcements in Pharmacopeial Forum 48(3) [May–Jul. 2022] pursuant to the Rules and Procedures of the Council of Experts. If published as anticipated, the comment period for these revisions would end on July 31, 2022. In the absence of any adverse comments, the proposed IRAs will become official on November 1, 2022.
It is anticipated that the proposed revisions for Dalteparin Sodium monograph will be published as an In-Process Revision in Pharmacopeial Forum 48(3) [May–Jul. 2022] pursuant to the Rules and Procedures of the Council of Experts.

Should you have any questions, please contact Julie Zhang, Team Lead-Sr. Scientist II, (Julie.zhang@usp.org).


CN-22-32-00