USP Reference Standards for Biologics

As a required component of compendial standard procedures included in USP–NF monographs and general chapters, USP offers a growing list of highly characterized Reference Standards for method development, validation, and testing. When a USP Reference Standard is specified in a compendial standard procedure test or assay, it must be used in order for results to be deemed conclusive.

Part of the Reference Standard Development Process is Collaborative Testing. We currently have three opportunities for collaborative testing.USP’s catalog of supporting Reference Standards includes insulins and other peptides, low molecular weight heparins, endotoxins, excipients, amino acids, and an expanding list of articles for biomanufacturing. New work will involve monoclonal antibodies.  Scroll down for information about a new survey soliciting information about your needs in that area.

Learn more about the Reference Standards development process and how you can get involved.

Recently Released Biologics Reference Standards

View and order all USP Reference Standards here. Our catalog includes more than 3,200 items!

Biologics Standards in Development

  • Albumin Human
  • Bivalirudin
  • Coagulation Factor VIIa
  • CHO Genomic DNA
  • Chymotrypsin
  • Dermatan Sulfate
  • E. coli Genomic DNA
  • Erythropoietin
  • Glatiramer Acetate
  • Glucagon Receptor Cell Line
  • Interferon Beta-1A
  • Interferon Beta-1A for Bioidentity
  • Pegfilgrastim

Download a list of all USP Reference Standards Under Development that are anticipated to release within six months. This list is updated four times a year. If you would like to be notified about a USP Reference Standard under development, sign up for the Reference Standard Release Notification Service. You can also suggest a Reference Standard.