GLP1 Therapies

USP is expanding the portfolio of Reference Standards, Analytical Reference Materials & Documentary Standards that help enable GLP-1 manufacturers to operate with high levels of confidence in the accuracy of their analytical results.

Empowering quality & confidence in GLP-1 development

The rapid rise of GLP-1 receptor agonists, including Exenatide, Liraglutide and Semaglutide, has reshaped the diabetes and weight management landscape. However, manufacturers face critical challenges ensuring the purity and regulatory compliance of their formulations along with the analytical accuracy of their test methods. USP is engaging with GLP-1 agonist manufacturers to provide a holistic solution of physical materials and documentary guidance on product quality.

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USP Monographs

Reference Standards/Materials 

Exenatide (Reference Standard)
[Glu13]-Exenatide (Reference Standard)
[Met(O)14]-Exenatide (Reference Standard)
[N-Acetyl-His1]-Exenatide (Reference Standard)
[D-His1]-Exenatide (Reference Standard)
C-OH Exenatide (Analytical Reference Material)

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 Eptifibatide-based drugs. Please visit the USP store to explore our full range of reference standards for excipients.

Exenatide

USP Monographs

Reference Standards/Materials 

Exenatide (Reference Standard)
[Glu13]-Exenatide (Reference Standard)
[Met(O)14]-Exenatide (Reference Standard)
[N-Acetyl-His1]-Exenatide (Reference Standard)
[D-His1]-Exenatide (Reference Standard)
C-OH Exenatide (Analytical Reference Material)

Excipients:

Glacial Acetic Acid (Reference Standard)
Metacresol (Reference Standard)
Phenol (Reference Standard)
Polysorbate 20 (Reference Standard)
Sodium Acetate Trihydrate (Reference Standard)
Sucrose (Reference Standard)

Reference Standards/Materials 

[Kyn]31-Liraglutide (Analytical Reference Material)
Formaldehyde adduct-Liraglutide (Analytical Reference Material)
α-Glu(side Chain)-Liraglutide (Analytical Reference Material)
D-allo-Thr(11)-Liraglutide (Analytical Reference Material)
D-allo-Thr(13)-Liraglutide (Analytical Reference Material)

Excipients

Propylene Glycol (Reference Standard)
Phenol (Reference Standard)
Dibasic (Reference Standard)
Potassium phosphate, dibasic (Reference Standard)

Liraglutide

Reference Standards/Materials 

[Kyn]31-Liraglutide (Analytical Reference Material)
Formaldehyde adduct-Liraglutide (Analytical Reference Material)
α-Glu(side Chain)-Liraglutide (Analytical Reference Material)
D-allo-Thr(11)-Liraglutide (Analytical Reference Material)
D-allo-Thr(13)-Liraglutide (Analytical Reference Material)

Excipients

Propylene Glycol (Reference Standard)
Phenol (Reference Standard)
Dibasic (Reference Standard)
Potassium phosphate, dibasic (Reference Standard)

Reference Standards/Materials 

[Beta-Asp]15-Semaglutide (Analytical Reference Material)
[Beta-Hydroxybenzyl)-Trp]25-Semaglutide (Analytical Reference Material)
α-Glu(side chain)-Semaglutide (Analytical Reference Material)
Des-AEEA-Semaglutide (Analytical Reference Material)

Excipients

Propylene glycol (Reference Standard)
Phenol (Reference Standard)
Povidone (Reference Standard)
Microcrystalline cellulose (Reference Standard)

Semaglutide

Reference Standards/Materials 

[Beta-Asp]15-Semaglutide (Analytical Reference Material)
[Beta-Hydroxybenzyl)-Trp]25-Semaglutide (Analytical Reference Material)
α-Glu(side chain)-Semaglutide (Analytical Reference Material)
Des-AEEA-Semaglutide (Analytical Reference Material)

Excipients

Propylene glycol (Reference Standard)
Phenol (Reference Standard)
Povidone (Reference Standard)
Microcrystalline cellulose (Reference Standard)

USP-NF Chapters

Documentary Standards

USP-NF Chapters

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Empowering quality & confidence in GLP1 development

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USP Peptides Manufacturing and Testing

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Products and resources

Publications

Scientific articles
USP Peptides Manufacturing and Testing Infographic
Reference Standards to Support Quality of Synthetic Peptide Therapeutics
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

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Education

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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Packaging Standards

Explore our high-quality rubber oligomer reference standards, designed to support extractable & leachable testing in GLP-1 drug product packaging and delivery systems.

Rubber Oligomer 1 (5 mg) (1,1,5,5-tetramethyl-2-(prop-1-en-2-yl)cyclohexane)
Rubber Oligomer 2 (5 mg) (2-(3-chloroprop-1-en-2-yl)-1,1,5,5-tetramethylcyclohexane)
Rubber Oligomer 3 (5 mg) (1,1,5,5-Tetramethyl-2-(1-methylethenyl)-3-(2,2,4-trimethylpentyl)-cyclohexane)
Rubber Oligomer 4 (5 mg) (1,1,5,5-Tetramethyl-2-(1-chloromethylethenyl)-3-(2,2,4-trimethylpentyl)-cyclohexane)
Rubber Oligomer 5 (5 mg) (1,1,5,5-Tetramethyl-2-(1-bromomethylethenyl)-3-(2,2,4-trimethylpentyl)-cyclohexane)
Rubber Oligomer 6 (5 mg) (2-(3-bromoprop-1-en-2-yl)-1,1,5,5-tetramethylcyclohexane)
Rubber Oligomer 10 (5 mg) (2-(2,2,4,4-tetramethylcyclohexyl)prop-2-en-1-ol)

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Injectables

Injectables-related USP Documentary Standards

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GLP-1 Solutions

GLP1 Therapies​

USP is expanding the portfolio of Reference Standards, Analytical Reference Materials & Documentary Standards that help enable GLP-1 manufacturers to operate with high levels of confidence in the accuracy of their analytical results.

Empowering quality & confidence in GLP-1 development

Explore offerings

Exenatide

Liraglutide

Semaglutide​

Documentary Standards​

What's new

Flyer

Infographic

Products and resources

Publications

Education

Packaging Standards

Injectables

GLP1 Therapies

Semaglutide

Documentary Standards