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.
NEW! 21 Peptide Impurities
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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.
Please click on the peptide you are interested in to learn more.
The USP Bivalirudin Peptide family includes:
- USP Monographs:
- Bivalirudin Official as of 01-Dec-2023
- Bivalirudin Injection Official as of 01-Dec-2023
- API: Bivalirudin Reference Standard
- Process-related or degradant impurities:
- Excipients:
- Glacial Acetic Acid Reference Standard
- Mannitol Reference Standard
- Polyethylene Glycol (PEG) Reference Standards
- Sodium Acetate Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Bivalirudin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Calcitonin Salmon Peptide family includes:
- USP Monographs:
- API: Calcitonin Salmon Reference Standard
- Process-related or degradant impurities:
- Excipients:
- Benzalkonium Chloride Reference Standard
- Citric Acid Reference Standard
- Phenol Reference Standard
- Sodium Acetate Reference Standard
- Sodium Chloride Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Calcitonin Salmon-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Corticotropin Peptide family includes:
- USP Monographs:
- API: Corticotropin Reference Standard
- Excipients:
- Gelatin Reference Standard
- Glacial Acetic Acid Reference Standard
- L-Cysteine Hydrochloride Reference Standard
- Phenol Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Corticotropin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Cosyntropin Peptide family includes:
- USP Monograph: Cosyntropin
- API: Cosyntropin Acetate Refence Standard
- Excipients:
- Glacial Acetic Acid Reference Standard
- Mannitol Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Sodium Chloride Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Cosyntropin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Desmopressin Peptide family includes:
- USP Monographs:
- API: Desmopressin Acetate Reference Standard
- Excipients:
- Benzalkonium Chloride Reference Standard
- Benzyl Alcohol Reference Standard
- Citric Acid Reference Standard
- Croscarmellose Sodium Reference Standard
- Dextrose Reference Standard
- Palmitic Acid Reference Standard
- Povidone Reference Standard
- Sodium Chloride Reference Standard
- Stearic Acid Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Desmopressin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Eptifibatide Peptide family includes:
- USP Monograph: Eptifibatide ((not yet official), in PF 49(2))
- API: Eptifibatide Reference Standard
- Process-related or degradant impurities:
- Excipients:
- Citric Acid Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Eptifibatide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Exenatide Peptide family includes:
- USP Monographs:
- API: Exenatide Reference Standard
- Process-related or degradant impurities:
- Excipients:
- Glacial Acetic Acid Reference Standard
- Metacresol Reference Standard
- Phenol Reference Standard
- Polysorbate 20 Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Sucrose Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Exenatide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Glucagon Peptide family includes:
- USP Monographs:
- Glucagon -
- Official as of 01-Dec-2023
- Glucagon For Injection
- Glucagon -
- API: Glucagon (HUMAN) Reference Standard
- Excipients:
- Dextrose Reference Standard
- Fructose Reference Standard
- Glycerin Reference Standard
- Lactose Monohydrate Reference Standard
- Mannitol Reference Standard
- Sucrose Reference Standard
- Trehalose Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Glucagon-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Gonadorelin Peptide family includes:
- USP Monographs:
- APIs:
- Process-related or degradant impurities:
- Excipients:
- Glacial Acetic Acid Reference Standard
- Mannitol Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Sodium Chloride Reference Standard
- Sorbitol Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Gonadorelin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Goserelin Peptide family includes:
- USP Monographs:
- API: Goserelin Acetate Reference Standard
- Process-related or degradant impurities:
The USP Leuprolide Peptide family includes:
- USP Monograph: Leuprolide Acetate
- API: Leuprolide Acetate Reference Standard
- Process-related or degradant impurities:
- [Pro(Ac)]1-Leuprolide Analytical Reference Material
- [D-His]-Leuprolide Analytical Reference Material
- [L-Leu]6-Leuprolide Analytical Reference Material
- [D-Ser]-Leuprolide Analytical Reference Material
- [Ser(Ac)]4-Leuprolide Analytical Reference Material
- NEW! Quality Solution Sheet: Leuprolide
- Excipients:
- Gelatin Reference Standard
- Glacial Acetic Acid Reference Standard
- Mannitol Reference Standard
- Methylpyrrolidone Reference Standard
- Polysorbate 80 Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Leuprolide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Octreotide Peptide family includes:
- USP Monograph: Octreotide Acetate
- API: Octreotide Acetate Reference Standard
- System Suitability: Octreotide Non-Cyclic System Suitability Marker Refence Standard
- Process-related or degradant impurities:
- [Lys(Ac)]5-Octreotide Analytical Reference Material
- Parallel Dimer-Octreotide Analytical Reference Material - coming soon!
- Anti-Parallel Dimer-Octreotide Analytical Reference Material - coming soon!
- [O1(Ac)]8-Octreotide Analytical Reference Material
- [Phe(Ac)]1-Octreotide Analytical Reference Material
- N-Acetyl-Lys-Octreotide Trifluoroacetate Analytical Reference Material
- N-Acetyl-Phe-Octreotide Trifluoroacetate Analytical Reference Material
- NEW! Quality Solution Sheet: Octreotide
- Excipients:
- Aleuritic Acid Reference Standard
- Diethylene glycol Reference Standard
- Ethylene glycol Reference Standard
- Gelatin Reference Standard
- Glyceryl Mono and Dicaprylocaprate Reference Standard
- Magnesium Chloride Reference Standard
- Methyl Caprate Reference Standard
- Methyl Caproate Reference Standard
- Methyl Caprylate Reference Standard
- Methyl Laurate Reference Standard
- Methyl Myristate Reference Standard
- Polysorbate 80 Reference Standard
- Povidone Reference Standard
- Propylene glycol Reference Standard
- Refined Bleached Shellac Reference Standard
- Regular Bleached Shellac Reference Standard
- Sodium Caprylate Reference Standard
- Sodium Lauryl Sulfate Reference Standard
- Triethyl Aconitate Reference Standard
- Triethyl Citrate Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Octreotide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Oxytocin Peptide family includes:
- USP Monographs:
- API: Oxytocin Reference Standard
- System Suitability: Oxytocin Identification Reference Standard
- Process-related or Degradant Impurities:
- [Cys(Ac)]1-Oxytocin Analytical Reference Material
- [Asp]5-Oxytocin Analytical Reference Material
- [Glu]4-Oxytocin Analytical Reference Material
- D-[Asp]5-Oxytocin Analytical Reference Material
- Parallel Dimer-Oxytocin Analytical Reference Material
- Anti-parallel Dimer-Oxytocin Analytical Reference Material
- NEW! Quality Solution Sheet: Oxytocin
- Excipients:
- Chlorobutanol Reference Standard
- Citric Acid Reference Standard
- Diethylene glycol Reference Standard
- Ethylene glycol Reference Standard
- Glycerin Reference Standard
- Methylparaben Reference Standard
- Propylparaben Reference Standard
- Sodium Chloride Reference Standard
- Sorbitol Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Oxytocin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Protamine Sulfate Peptide family includes:
- USP Monographs:
- API: Protamine Sulfate Reference Standard
The USP Teriparatide Peptide family includes:
- USP Monographs:
- API: Teriparatide Reference Standard
- Process-related or degradant impurities:
- [MetO8]-Teriparatide Analytical Reference Material - coming soon!
- [MetO18]-Teriparatide Analytical Reference Material - coming soon!
- [Met+O8,18] Teriparatide Analytical Reference Material - coming soon!
- NEW! ! Quality Solution Sheet: Teriparatide
- Excipients:
- Diethylene Glycol Reference Standard
- Diglycine Reference Standard
- Ethylene Glycol Reference Standard
- Glacial Acetic Acid Reference Standard
- Glycerin Reference Standard
- Glycine Reference Standard
- l-Methionine Reference Standard
- Mannitol Reference Standard
- Metacresol Reference Standard
- N-Acetyl-d,l-Methionine Reference Standard
- Phenol Reference Standard
- Sodium Acetate Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Sodium Chloride Reference Standard
- Triglycine Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Teriparatide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Triptorelin Peptide family includes:
- USP Monograph: Triptorelin Pamoate ((not yet official), in PF 48(5))
- API: Triptorelin Acetate Reference Standard
- Process-related or degradant impurities:
- Excipients:
- Mannitol Reference Standard
- Polysorbate 80 Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used in Triptorelin-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Vasopressin Peptide family includes:
- USP Monographs:
- APIs:
Infographic
USP Peptides Manufacturing and Testing
Article
Reference Standards to Support Quality of Synthetic Peptide Therapeutics
USP-NF: General Chapter <1106.1>
Immunogenicity Assays – Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody
Workshop
Therapeutic Peptides and Oligonucleotides
Resources
Education
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
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Product Information
- USP Peptide Specification Sheet (English, Spanish, Portuguese)
- Best Practices for Reconstitution of USP Peptide Reference Standards
- Particle Count Set Quality Solution Sheet
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FDA Regulatory Information
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