Teduglutide: Peptide Profile, CAS & Properties
CAS 197922-42-2 · 3752.13 g/mol
Teduglutide (CAS 197922-42-2) is a 33-amino-acid glucagon-like peptide-2 (GLP-2) receptor agonist analogue with molecular formula C164H252N44O55S. Approved by the US FDA and EMA in 2012 for short bowel syndrome, it resists DPP-4 degradation via a Gly-for-Ala substitution at position 2. This page provides reference information on Teduglutide.
- CAS Number
- 197922-42-2
- Molecular Formula
- C164H252N44O55S
- Molecular Weight
- 3752.13 g/mol
- Drug Class
- GLP-2 analogue
What is Teduglutide?
Teduglutide is an analogue of human glucagon-like peptide-2 (GLP-2), a 33-amino-acid peptide derived from the native GLP-2 sequence. A single substitution of glycine for alanine at position 2 from the N-terminus confers resistance to degradation by dipeptidyl peptidase-4 (DPP-4), extending its in-vivo half-life relative to native GLP-2. As a GLP-2 receptor agonist it regulates the functional and structural integrity of the intestinal epithelium; in animal and clinical studies it has been shown to increase villus height and crypt depth, expanding the absorptive surface area of the intestine.
As an active pharmaceutical ingredient (API), teduglutide (CAS 197922-42-2, molecular formula C164H252N44O55S, ~3752.13 g/mol) is a lyophilised powder formulated into injectable finished dosage forms. It is an approved active: the US FDA granted approval in December 2012 and the EMA / European Commission in August 2012, for short bowel syndrome in patients dependent on parenteral support.
How Teduglutide Is Produced & Characterised
Teduglutide is a synthetically demanding 33-mer peptide: its length, the single methionine residue and the closely related deletion and oxidation variants all create real purification challenges. Industrially, peptides of this class are typically produced by Fmoc solid-phase peptide synthesis (SPPS), in which the chain is assembled residue-by-residue on a resin support through controlled coupling and deprotection cycles. The crude peptide is then purified by preparative reversed-phase HPLC — often on dynamic axial compression (DAC) columns — to resolve the target sequence from related impurities and to manage methionine oxidation.
Process controls aim for repeatable batch-to-batch consistency from optimisation runs through to larger campaigns, with controlled lyophilisation yielding a stable, uniform powder. Characterisation of the resulting material commonly combines UPLC/HPLC for purity, LC-MS for sequence and impurity profiling, and assays for water content, counter-ion content, residual solvents and peptide content, reflecting general analytical practice for therapeutic peptides.
Typical Quality Specifications & Impurity Profile
Therapeutic peptide APIs such as teduglutide are generally released against a defined specification with a Certificate of Analysis. Purity is typically determined by UPLC/HPLC, while sequence and minor structural variants are confirmed by LC-MS impurity profiling. Pharmaceutical-grade material commonly targets purity of ≥99.0%, with individual impurities controlled below 0.10%, supported by ICH Q1A(R2) long-term and accelerated stability data.
For a 33-mer such as teduglutide, characteristic critical quality attributes include deletion sequences, methionine oxidation variants, water content and acetate or other counter-ion content. Analytical methods used for these molecules are usually validated to ICH Q2(R1). The information here describes typical industry specifications for reference and does not represent a product offering.
Regulatory & Approval Status
Teduglutide is an approved active pharmaceutical ingredient. The US FDA approved it in December 2012 and the EMA / European Commission in August 2012, for the treatment of adults and children with short bowel syndrome who are dependent on parenteral support. As an approved active, it is the subject of established regulatory documentation frameworks — for example US Drug Master Files (Type II) and CTD Module 3 CMC sections used by manufacturers when referencing the substance in IND, NDA or ANDA submissions.
Quality systems for peptide APIs of this type are generally aligned with pre-approval-inspection (PAI) expectations of agencies such as the FDA, EMA and PMDA. This section is provided as educational regulatory context for the molecule and is not a representation of supply, sourcing or documentation services from WinHyCare.
Teduglutide API — Specifications
| Compound | Teduglutide |
|---|---|
| CAS Number | 197922-42-2 |
| Molecular Formula | C164H252N44O55S |
| Molecular Weight | 3752.13 g/mol |
| Sequence | 33 amino acids (Gly²-substituted, DPP-4 resistant) |
| Drug Class | GLP-2 analogue (GLP-2 receptor agonist) |
| Appearance | White to off-white lyophilised powder |
| Typical Purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis Route | Fmoc SPPS + DAC prep-HPLC purification |
| Regulatory Status | Approved (US FDA 2012; EMA / EC 2012) |
| Form | Lyophilised powder for injectable formulation |
Reference data only — WinHyCare neither supplies nor manufactures this compound; see our Semaglutide API for the product we supply. Regulatory status: Approved as an active ingredient by major regulators including the US FDA (December 2012) and the EMA / European Commission (August 2012) for the treatment of adults and children with short bowel syndrome who are dependent on parenteral support.
Teduglutide API — Frequently Asked Questions
What is Teduglutide?
Teduglutide is a 33-amino-acid analogue of human glucagon-like peptide-2 (GLP-2) and a GLP-2 receptor agonist. A glycine-for-alanine substitution at position 2 confers resistance to dipeptidyl peptidase-4 (DPP-4) degradation, extending its half-life relative to native GLP-2. It regulates the structural and functional integrity of the intestinal epithelium.
What is the CAS number and molecular weight of Teduglutide?
Teduglutide's CAS number is 197922-42-2, its molecular formula is C164H252N44O55S, and its molecular weight is approximately 3752.13 g/mol. The peptide is 33 amino acids long.
Is Teduglutide approved?
Yes. Teduglutide is an approved active ingredient. The US FDA approved it in December 2012 and the EMA / European Commission in August 2012, for the treatment of adults and children with short bowel syndrome who are dependent on parenteral support.
What class of peptide is Teduglutide?
Teduglutide is a GLP-2 analogue — specifically a glucagon-like peptide-2 receptor agonist. It belongs to the gastrointestinal class of therapeutic peptides and is structurally based on the native human GLP-2 sequence.
What is Teduglutide used for?
Teduglutide is indicated for the treatment of short bowel syndrome in patients who are dependent on parenteral support. By acting on the GLP-2 receptor it increases villus height and crypt depth, expanding the absorptive surface area of the intestine.
How is Teduglutide produced?
Peptides such as teduglutide are typically produced by Fmoc solid-phase peptide synthesis (SPPS) — assembling the chain residue-by-residue on a resin through controlled coupling and deprotection cycles — followed by preparative reversed-phase (often DAC) HPLC purification and controlled lyophilisation to a stable powder. This describes the general industry approach for this peptide class.
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Technical Reference Page
WinHyCare neither supplies nor manufactures Teduglutide; this page is provided as a technical reference. The peptide API we supply is Semaglutide.