Peptide Standards

Peptides are pivotal therapeutics that patients rely on to treat diabetes, obesity, cancer and more. Developers of these life-saving medicines face challenges interpreting regulations for biologics and small molecules that exclude peptides. USP supplies comprehensive peptide solutions including clear documentary standards with validated test methods, acceptance criteria and highly characterized API and impurity reference standards and materials.

These tools help manufacturers minimize contaminants and build their control strategy. Clearly defined standards and guidance from USP help investigators and regulators save time and resources on the way to regulatory success.

USP Peptide Families

USP has assembled peptide families, consisting of peptide API Reference Standards, related impurity reference standards and Analytical Reference Materials. USP Reference Standards and materials can be used to develop and validate analytical methods, verify that compendial methods are fit for purpose in your laboratory, qualify equipment as well as control the quality of drug substance and product batches.

Learn how USP Peptide Reference Standards and Analytical Reference Materials work

Please click on the peptide you are interested in to learn more.

The USP Bivalirudin Peptide family includes:

The USP Calcitonin Salmon Peptide family includes:

The USP Corticotropin Peptide family includes:

The USP Cosyntropin Peptide family includes:

The USP Desmopressin Peptide family includes:

The USP Eptifibatide Peptide family includes:

The USP Exenatide Peptide family includes:

The USP Glucagon Peptide family includes:

The USP Gonadorelin Peptide family includes:

The USP Leuprolide Peptide family includes:

The USP Octreotide Peptide family includes:

The USP Oxytocin Peptide family includes:

The USP Protamine Sulfate Peptide family includes:

The USP Teriparatide Peptide family includes:

The USP Triptorelin Peptide family includes:

The USP Vasopressin Peptide family includes:

What's New

peptide impurities coming soon

USP is excited to announce the upcoming lineup of NEW Peptide Impurities, headlined by Bivalirudin, Calcitonin, Cosyntropin Desmopressin, Exenatide, Glucagon, and Vasopressin. With USP’s expanding selection of materials, you can develop high-quality medicines with greater confidence and certainty.

macrocyclic peptides

Macrocyclic peptides

Refer to chapters <1503> & <1504> for a thorough quality assessment of macrocyclic peptides.

USP Peptides Manufacturing and Testing

Infographic

USP Peptides Manufacturing and Testing

Immunogenicity Assays – Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody

USP-NF: General Chapter <1106.1>

Immunogenicity Assays – Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody

Therapeutic Peptides and Oligonucleotides

Workshop

Therapeutic Peptides and Oligonucleotides

 

Products & Resources


Education

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Product Information

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FDA Regulatory Information

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Formulation and Packaging Standards

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Injectable Standards

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