Peptide pharmaceuticals are valuable therapies that are highly selective, have low toxicity, and are relatively economical to manufacture. Peptides can be manufactured synthetically (using solid-phase peptide synthesis (SPPS) or by employing recombinant DNA technology.
The United States Pharmacopeia (USP) publishes official monographs and general chapters that provide quality standards for drug substances and products across the world. These documentary standards focus on the quality attributes of identity, purity, safety, and potency of the drug products regulated by authorities that enforce these standards. Peptide-related USP Reference Standards are closely tied to our documentary standards and are directly associated with official monographs published in the USP–NF. These highly characterized physical specimens are used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality and purity of peptide-based medicines.
Peptide-related USP-NF Documentary Standards and USP Reference Standards
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Product Information
FDA Regulatory Information
Educational Resources
Ensuring the identity, quality, purity, and consistency of medication is fundamental to protecting public health. Peptide-related USP documentary standards can give drug manufacturers confidence in developing high-quality medicines. Peptide-related USP Reference Standards are closely tied to our documentary standards. Based directly on official monographs published in the USP–NF, these highly characterized physical specimens are used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality and purity of peptide-based medicine
Below is a current list of Peptide-related USP official standards published in the USP-NF, with related USP Reference Standards and Associated Impurity Reference Standards.
- Reference Standards to Support Quality of Synthetic Peptide Therapeutics, Pharmaceutical Research (Published March 22, 2023) (McCarthy, D., Han, Y., Carrick, K. et al.)
- Peptides and recombinant protein therapeutics can elicit product-specific anti-drug antibodies (ADAs) that can impact their safety and efficacy.
- USP Peptide Specification Sheet (English, Spanish, Portuguese)
- Best Practices for Reconstitution of USP Peptide Reference Standards
- Particle Count Set Quality Solution Sheet
Scientific articles
- NEW: USP Peptides Manufacturing and Testing Infographic
- NEW: Reference Standards to Support Quality of Synthetic Peptide Therapeutics
- NEW: Impurity Control Strategies for Therapeutic Peptides
- Reference Standards to Support Quality of Synthetic Peptide Therapeutics
- Peptides Best Practices on Regulatory & Control Strategies, Analytical Methods, and More
- Survey of peptide quantification methods and comparison of their reproducibility: A case study using oxytocin
- Triptorelin Acetate: A Therapeutic Peptide Case Study
- Control Strategies for Synthetic Therapeutic Peptide APIs — Part 1: Analytical Considerations
- Control Strategies for Synthetic Therapeutic Peptide APIs — Part 2: Raw Material Considerations
- Control Strategies for Synthetic Therapeutic Peptide APIs — Part 3: Manufacturing Process Considerations
- Quantitative Analysis of Impurities in Unfractionated Heparin of Bovine Origin
Online courses and webinars
- CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences
- Characterization of Low-level D-Amino Acid Degradation Impurities Using Liquid Chromatography-High Resolution Tandom Mass Spectrometry
- Considerations of Comparative Studies for Complex Synthetic Peptide Products
- Control Strategies and analytical Test Methods for Peptide-Conjugates
- Drug Delivery Systems and Life Cycle Management for Peptides Beyond the Vial and Syringe
- Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug Development
- Fmoc Alpha Methyl Quaternary Amino Acid Supply Chain Development
- Quantitation of Impurities in Tirzepatide Peptide Fragments by High Resolution Ultra-High Pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS)
- Regulatory considerations for Setting Smart Starting Material Specifications
- Risk Assessment for a Nitrosamine Contamination of Peptide APIs Manufactured by Solid-Phase Peptide Synthesis (SPPS)
- Synthesis of Tirzepatide by Native Chemical Ligation (NCL), a Once-weekly dual GIP and GLP-1 Receptor Agonist
- USP Standards to Support Quality of Peptide Therapeutics
- Vendor Selection for Unusual Amino Acid Derivatives
Support development of new peptide standards
USP continues to increase the number of peptide-related monographs in the United States Pharmacopeia-National Formulary (USP–NF). Included in the table below are some of the monographs and general chapters currently under development or in revision (labeled with an *). A complete listing can be found in USP’s Pharmacopeial Forum (PF), a free bimonthly online journal where proposed monographs and general chapters are published for public review and comment before becoming official. To learn more, visit https://www.uspnf.com/ pharmacopeial-forum.
In addition, your participation in our standards-setting process is vital to the development of relevant USP–NF monographs. USP seeks sponsors as well as analytical methods to help develop the following monographs:
- Ganirelix
- Icatibant
- Liraglutide
Learn how you can donate material or methods by visiting our biologics standards engagement page or by contacting us at uspbiologics@usp.org.
Reference Standards Release Notification Service
USP also continues to develop antibiotic-related Reference Standards. To learn more, sign up for our Reference Standards Release Notification Service: