USP Reference Standards for Biologics & Biotechnology

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.

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

Recently Released

  • rAlbumin Human (Item # 1012595)
  • Calcitonin Salmon (Item # 1086200)
  • Calcitonin Salmon Related Compound A (Item # 1086210)
  • Calcitonin Salmon Related Compound B (Item # 1086221)
  • Enoxaparin Sodium for Bioassays (Items # 1235831)
  • rGlucagon (Item # 1294036)
  • D-Glucuronic Acid (Item # 1294319)
  • Gonadorelin Hydrocholoride (Item # 1296803)
  • Goserelin System Suitability Mixture (Item # 1297250)
  • Filgrastim (Item # 1270435)
  • Heparin Sodium Molecular Weight Calibrant (Item # 1304107)
  • Insulin Aspart (Item # 1342037)
  • Protein A (Item # 1578805)
  • Octreotide Acetate (Item #1477604)
  • Octreotide Acetate (non-cyclic) System Suitability Marker (Item # 1477615)

View and order these and other USP Reference Standards. Our complete catalog includes more than 3,000 items!

In Development

  • Acarbose
  • Acarbose System Suitability Mixture
  • Cosyntropin Acetate
  • Epoetin for Assays
  • Fetal Bovine Serum
  • rHuman Interleukin 4
  • Low Molecular Weight Heparins Molecular Weight Calibrant
  • Pepsin for Assay
  • Oligosaccharide System Suitability Standards

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.