Blood-Related Standards

Standards Updates

Pharmacopeial Forum Updates

Documentary Standards Associated Reference Standards
Albumin Human (in PF 41(6), deferred pending release of the reference standard) Albumin Human, due for release in late June 2019.
Eptacog Alpha Activated
Eptacog Alpha Activated Injection
Coagulation Factor VIIa (released)
Coagulation Factor VIIa for Bioassay, due for release in late June 2019.

Official in USP-NF

Documentary Standards Associated Reference Standards
<165> Prekallikrein Activator
(Official in USP 40-NF 35)
Prekallikrein Activator RS
Antithrombin III Human
(Official in USP 39 - NF 34, Second Supplement)
Antithrombin III Human

New Reference Standards Releases

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Collaborative Testing Opportunities

We are seeking collaborative test sites for the following blood-related standards:

  • Albumin Human
  • Coagulation Factor VIIa for Bioassay

For more information contact

Blood-Related Standards–Collaborate with USP

Building on the experience in setting standards for biologicals, USP continues to develop standards that are applicable to blood products. Additional standards for critical reagents are under consideration. Comments and queries should be addressed to

Our work with blood-related standards is guided by scientific experts from a variety of disciplines and industries in the BIO3 Complex Biologics Expert Committee and associated expert panels. Find out what the BIO3 expert committee is up to by reviewing its work plan:

A new expert panel, Coagulation Factors Expert Panel, will be formed soon. Check back here for information about the call for candidates for this new panel.