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.
Reference Standards (RSs):
- Used for controlling the quality of peptide therapeutics as required by monograph methods.
- Used to develop/validate/verify/trend in-house methods
Analytical Reference Materials (ARMs):
- Used to help identify impurities during method development, validation and verification.
- Impurities may be listed in impurity tables within product-specific monographs but are not required to be run for every lot.
- Used for trouble shooting or investigations throughout product lifecycle.
To learn about all our peptide standards, materials, and resources, please visit the USP Peptides page.
Bivalirudin Peptide family
The USP Bivalirudin Peptide family includes:
- USP Monographs:
- Bivalirudin (not yet official), in PF48(2)) - To be official 01-Dec-2023
- Bivalirudin Injection ((not yet official), in PF48(2)) - To be official 01-Dec-2023
- API: Bivalirudin Reference Standard
- Process-related or degradant impurities:
Calcitonin Salmon Peptide family
The USP Calcitonin Salmon Peptide family includes:
- USP Monographs:
- API: Calcitonin Salmon Reference Standard
- Process-related or degradant impurities:
Corticotropin Peptide family
The USP Corticotropin Peptide family includes:
Cosyntropin Peptide family
The USP Corticotropin Peptide family includes:
- USP Monograph: Cosyntropin
- API: Cosyntropin Acetate Refence Standard
Desmopressin Peptide family
The USP Desmopressin Peptide family includes:
Eptifibatide Peptide family
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:
Exenatide Peptide family
The USP Exenatide Peptide family includes:
- USP Monographs:
- API: Exenatide Reference Standard
- Process-related or degradant impurities:
Glucagon Peptide family
The USP Glucagon Peptide family includes:
- USP Monographs:
- Glucagon
- Revision to be official 01-Dec-2023 (in PF48(2))
- Glucagon For Injection
- Glucagon
- API: Glucagon (HUMAN) Reference Standard
Gonadorelin Peptide family
The USP Gonadorelin Peptide family includes:
- USP Monographs:
- APIs:
- Process-related or degradant impurities:
Goserelin Peptide family
The USP Goserelin Peptide family includes:
- USP Monographs:
- API: Goserelin Acetate Reference Standard
- Process-related or degradant impurities:
Leuprolide Peptide family
The USP Leuprolide Peptide family includes:
- USP Monograph: Leuprolide Acetate
- API: Leuprolide Acetate Reference Standard
- Process-related or degradant impurities:
- Acetyl-Leuprolide Analytical Reference Material - coming soon!
- D-His-Leuprolide Analytical Reference Material - coming soon!
- [L-Leu6]-Leuprolide Analytical Reference Material - coming soon!
- D-Ser-Leuprolide Analytical Reference Material - coming soon!
- [Ser(Ac)]4-Leuprolide, Acetyl-leuprolide Analytical Reference Material - coming soon!
- NEW! Quality Solution Sheet: Leuprolide
Octreotide Peptide family
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:
- [Acetyl-Lys5]-Octreotide Analytical Reference Material - coming soon!
- Parallel Dimer-Octreotide Analytical Reference Material - coming soon!
- Anti-Parallel Dimer-Octreotide Analytical Reference Material - coming soon!
- O1,8-acetyloctreotide, EP Impurity F Analytical Reference Material - coming soon!
- N2,1-acetyloctreotide, EP Impurity I Analytical Reference Material - coming soon!
- N-Acetyl-Lys-Octreotide Trifluoroacetate Analytical Reference Material - coming soon!
- N-Acetyl-Phe-Octreotide Trifluoroacetate Analytical Reference Material - coming soon!
- NEW! Quality Solution Sheet: Octreotide
Oxytocin Peptide family
The USP Oxytocin Peptide family includes:
- USP Monographs:
- API: Oxytocin Reference Standard
- System Suitability: Oxytocin Identification Reference Standard
- Process-related or Degradant Impurities:
- Ac-Oxytocin Analytical Reference Material - coming soon!
- [Asp]5-Oxytocin Analytical Reference Material - coming soon!
- [Glu]4-Oxytocin Analytical Reference Material - coming soon!
- D-[Asp]5-Oxytocin Analytical Reference Material - coming soon!
- Parallel Dimer-Oxytocin Analytical Reference Material - coming soon!
- Anti-parallel Dimer-Oxytocin Analytical Reference Material - coming soon!
- NEW! Quality Solution Sheet: Oxytocin
Protamine sulfate Peptide family
The USP Protamine Sulfate Peptide family includes:
- USP Monographs:
- API: Protamine Sulfate Reference Standard
Teriparatide Peptide family
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
Triptorelin Peptide family
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:
Vasopressin Peptide family
The USP Vasopressin Peptide family includes:
- USP Monographs:
- APIs: