Peptides

Standards Updates

Official in USP 39 - NF 34, Second Supplement

Release Date: December 1, 2016

Documentary Standards Associated Reference Standards
Octreotide Acetate Octreotide Acetate; Octreotide Non-Cyclic System Suitability Marker

Documentary Standards Updates

Documentary Standards Status
Triptorelin Pamoate (NEW) Published in PF 43(3) on May 1, 2017, comments due July 31, 2017.
Desmopressin Acetate Published in PF 43(3) on May 1, 2017, comments due July 31, 2017.
Exenatide Injection (NEW) Due to be published in during the summer.
Eptifibatide (NEW) In development

Reference Standards

Reference Standards NEW Reference Standards in Development
Exenatide (NEW)
[Glu13]-Exenatide
[Met(O)14]-Exenatide
[N-Acetyl1-His1]-Exenatide
Calcitonin Salmon Related Compound A
Bivalirudin
Bivalirudin Asp9
Bivalirudin des-Glu13
 
[D-His2]-Gonadorelin
[D-Tyr5]-Gonadorelin
 
Triptorelin Acetate
Triptorelin Related Compound A
Triptorelin Related Compound B
Triptorelin Related Compound C
 
Glucagon Receptor Cell Line
 
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
  • Leuprolide Acetate

Contact peptides@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 peptides@usp.org

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 peptides@usp.org

Publications

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