Peptides

Standards Updates

Recent publications in Pharmacopieal Forum

Open for comment in Pharmacopieal Forum 44(2)
Published March 1, 2018

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 mid 2019:
Bivalirudin
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
Bivalirudin Asp9
Bivalirudin des-Glu13
 
[D-His2]-Gonadorelin
[D-Tyr5]-Gonadorelin
 
Triptorelin Acetate
Triptorelin Related Compound A (To be released January 2019)
Triptorelin Related Compound B (Released)
Triptorelin Related Compound C

Eptifibatide
D-Har-Eptifibatide

New Reference Standards Releases

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Collaborative Testing Opportunities

We are seeking collaborative test sites for the following peptides:

  • Bivalirudin
  • Gonadorelin Acetate

Contact biotech@usp.org.

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 biotech@usp.org

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 biotech@usp.org

Publications

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