Teduglutide is a 33-amino-acid recombinant peptide and glucagon-like peptide-2 (GLP-2) analogue used for the treatment of Short Bowel Syndrome (SBS) in patients dependent on parenteral support. It is manufactured using recombinant DNA technology in a modified strain of Escherichia coli. Teduglutide differs from naturally occurring human GLP-2 by substitution of alanine with glycine, which contributes to increased resistance to degradation by dipeptidyl peptidase-4.
Teduglutide is a peptide therapeutic containing 33 amino-acid residues. Its sequence is:
HGDGSFSDEMNTILDNLAARDFINWLIQTKITD
The peptide has a molecular formula of C164H252N44O55S and a molecular weight of approximately 3752.1 Da. PubChem lists CAS 197922-42-2 for Teduglutide.
Teduglutide acts as a GLP-2 receptor agonist and is designed to enhance intestinal adaptation and reduce dependence on parenteral nutritional/fluid support in patients with Short Bowel Syndrome.
PubChem identifies Teduglutide as a 33-membered polypeptide and recombinant GLP-2 analogue. FDA labeling describes the drug substance as a clear, colorless to light-straw-colored liquid before formulation into the finished lyophilized product.
Teduglutide is primarily used for the treatment of Short Bowel Syndrome (SBS) in adults and pediatric patients aged 1 year and older who are dependent on parenteral support.
As a GLP-2 receptor agonist, teduglutide promotes intestinal growth and improves intestinal absorptive capacity. This can help reduce the need for parenteral nutrition and intravenous fluid support in appropriately treated SBS patients.
Because Teduglutide is a peptide API, quality control requires peptide-specific analytical characterization rather than relying solely on conventional small-molecule tests.
The current EMA assessment identifies active-substance testing for:
Additional peptide characterization can include peptide mapping, sequence confirmation, oxidation/deamidation monitoring, aggregate/oligomer assessment and bioassay/relative potency.
Swapnroop supports pharmaceutical API requirements with quality-focused analytical testing, technical documentation and supply support for pharmaceutical development and manufacturing.
Teduglutide API can be supported with appropriate specifications, analytical documentation and batch-specific CoA according to the intended pharmaceutical application.
Teduglutide is a sensitive peptide and should be protected from inappropriate temperature, moisture and environmental exposure. The EMA assessment reports active-substance packaging in a low-density polyethylene (LDPE) bag compliant with applicable EU packaging requirements.
Storage conditions should always follow the approved specification and stability data for the particular Teduglutide API form and batch.
Documentation may include:
Swapnroop focuses on quality-oriented pharmaceutical API solutions supported by analytical testing and technical documentation. Teduglutide can be supplied according to agreed specifications and customer requirements for pharmaceutical development and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |