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 early 2018
Eptacog Alpha Activated
Eptacog Alpha Activated Injection
(due to be published in PF 43(4) July 3, 2017, comments due September 30, 2017)
Coagulation Factor VIIa
Coagulation Factor VIIa for Bioassay, due for release early 2018

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

Sign up to receive notices when new reference standards become available.

Sign Up

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 bloodproducts@usp.org.

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 bloodproducts@usp.org.

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.