Standards Updates

Recent publications in Pharmacopieal Forum

Open for comment in Pharmacopieal Forum 44(2)
Published March 1, 2018, comments due May 31, 2017

Documentary Standards Associated Reference Standards

Bivalirudin (new)
Bivalirudin for Injection (new)

Desmopressin Acetate
Gonadorelin Acetate

<1055> Biotechnology-Derived Articles – Peptide Mapping

3 New Reference Standards due to be released next winter:
Bivalirudin Asp9
Bivalirudin des-Glu14

Open for comment in Pharmacopieal Forum 44(1)

Documentary Standards Updates

Documentary Standards Status
Exenatide Injection (NEW) Published in PF 43(5), official in USP41-NF 36, 2nd Supplement, Dec 1, 2018.
Eptifibatide (NEW) In development.

Reference Standards

Reference Standards NEW Reference Standards in Development
rGlucagon (new use)
Bivalirudin Asp9
Bivalirudin des-Glu13
Triptorelin Acetate
Triptorelin Related Compound A
Triptorelin Related Compound B
Triptorelin Related Compound C
Glucagon Receptor Cell Line


USP Staff at TIDES

Meet with USP staff at our exhibit booth at TIDES Conference in Boston, MA May 7-10, 2018. Don’t miss Dr. Michael Huang, Senior Science and Standards Liaison at USP, on May 9, addressing the topic, “Update on USP Standards for Therapeutic Peptides and Impurity Measurements.”

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 peptides:

  • Bivalirudin
  • Gonadorelin Acetate
  • Leuprolide Acetate


Collaborate with Us on Monograph Modernization

As the role of biologic drugs continues to expand in the therapeutic arena, USP is committed to collaborating with scientific leaders in the biopharmaceutical community to update existing and develop new quality standards that support activities in the discovery, development, manufacturing, and distribution of biologics. Learn more about the development and revision process and how you can get involved.

USP is actively seeking sponsors for the modernization of the following peptides monographs:

  • Oxytocin
  • Oxytocin Injection

To learn more about modernization, please contact us, at

Upcoming Workshop

4th Peptide Workshop, November 6–7, 2017, USP-Rockville, MD USA USP is bringing its Therapeutic Peptides Workshop back again in 2017 for a more in-depth program which will examine GMP manufacturing considerations, analytical characterizations, CMC and formulation for diverse delivery systems, and USP updates.

Biologics Monographs 1 - Peptides Expert Committee

USP's Peptides Expert Committee directs the organization's work on synthetic peptide, hormone, and insulin standards. Review the committee's workplan and learn more. Your feedback and questions are always welcome at


Read USP's Therapeutic Peptides Expert Panel's three-part series "Control Strategies for Synthetic Therapeutic Peptide APIs":