USP Reference Standards for Bivalirudin

Bivalirudin is a short, synthetic peptide. Bivalirudin drug products act as potent and highly specific inhibitors of thrombin.

With more than a dozen drug substance manufacturers and 9 drug product manufacturers approved to manufacture Bivalirudin in the US, the development of public standards to support the quality of this vital therapeutic is essential. Bivalirudin drug products inhibit both circulating and clot-bound thrombin, while also inhibiting thrombin-mediated platelet activation and aggregation.

Bivalirudin drug products are used in patients as an anticoagulant. USP's Biologics Monographs 1 Expert Committee has collaborated with multiple US-approved sponsors to develop two new monographs, Bivalirudin and Bivalirudin for Injection.

In line with USP's mission of promoting public health and ensuring quality of drugs, the monographs include multiple orthogonal identification methods (including a bioidentity method to ensure activity), as well as multiple chromatographic methods to determine content and impurities. In parallel to publication of the monographs, USP has completed collaborative testing of three new Reference Standards (RS) that support the monographs.

About USP Bivalirudin RS:

  • Only pharmacopeial standard on Bivalirudin 
  • These are the only existing public standards for this product

The USP Bivalirudin Reference Standards Family:

  • USP Bivalirudin RS #1076013 (5 mg/vial)
  • [Asp9]-Bivalirudin RS #1076024 (1 mg/vial)
  • [DES-GLU13] Bivalirudin #1076035 (1 mg/vial)

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