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Enoxaparin Sodium and Enoxaparin Sodium Injection

Type of Posting: Revision Bulletin

Posting Date: 28–Oct–2011

Official Date: 01–Dec–2011

Expert Committee: Monographs—Biologics & Biotechnology 1

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Biologics & Biotechnology 1 Expert Committee has revised the Enoxaparin Sodium and Enoxaparin Sodium Injection monographs.

The purpose for the revision is to revise the name of potency reference standard from USP Enoxaparin Sodium Solution for Bioassays RS to USP Enoxparin Sodium for Bioassays RS, reflecting the new lyophilized formulation. Other than the RS name change, the Anti-Factor IIa and Anti-Factor Xa assays remain unchanged.

Additional corrections are introduced for compliance reasons:

  1. The percentage of the sample solution for Heavy Metals test in Enoxaparin Sodium monograph has been changed from 5% to 2.7% which yields the correct 30 ppm concentration.
  2. The formula in the Benzyl Alcohol Content in Enoxaparin Sodium Injection monograph has been corrected.
  3. The formula in the Free Sulfate Content in Enoxaparin Sodium Injection monograph has been corrected.
  4. The acceptance criteria for the Anti-Factor IIa Assay in Enoxaparin Sodium Injection Monograph has been corrected to account for both 100 mg/mL and 150 mg/mL formulations.

The Enoxaparin Sodium and Enoxaparin Sodium Injection Revision Bulletins supersede the currently official monographs. The Revision Bulletins will be incorporated in the First Supplement to USP 35–NF 30.

Should you have any questions, please contact Anita Szajek, Ph.D. (301-816-8325 or aey@usp.org).