Description

Teduglutide is a synthetic 33-amino acid peptide analog of human glucagon-like peptide-2 (GLP-2), designed to enhance intestinal mucosal growth and function. This compound is of critical importance as the active pharmaceutical ingredient (API) in treatments for conditions involving intestinal failure and malabsorption. It is primarily required by pharmaceutical manufacturers and research institutions developing and producing therapies for short bowel syndrome (SBS) and related gastrointestinal disorders.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key therapeutic component in injectable formulations for the treatment of Short Bowel Syndrome (SBS).
• Clinical Research & Development: Utilized in preclinical and clinical studies investigating novel treatments for intestinal failure, malabsorption syndromes, and gastrointestinal adaptation.
• Reference Standard: Serves as a high-purity analytical standard for quality control (QC) and research method validation in pharmaceutical laboratories.
• Peptide Chemistry Research: Used as a model compound in studies focusing on peptide stability, formulation, and delivery mechanisms.
• Biosimilar Development: Critical for companies developing biosimilar versions of GLP-2 analog therapies, requiring high-purity reference material.
• Drug Formulation Studies: Employed in the development of stable parenteral (injectable) dosage forms, including lyophilized powders and solutions.

Basic Information

Product Name	Teduglutide
CAS No.	197922-42-2
Molecular Formula	C164H252N44O55S
Molecular Weight	3752.1 g/mol
Synonyms	Recombinant human glucagon-like peptide-2 (1-33); GLP-2 (human, 1-33); GLP-2 analog; Teduglutide recombinant; Gattex (brand name); Revestive (brand name); (1-33)-GLP-2; [Gly2]-GLP-2
EINECS	Contact for details

Quality Control

Our Teduglutide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting stringent specifications for pharmaceutical-grade active ingredients. Certificates of Analysis (COA) detailing results for assay, related substances, residual solvents, endotoxins, and bioburden are provided. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or as specified on the label. Due to its hygroscopic (moisture-sensitive) nature, the product should be stored in a dry environment. For long-term storage, consider conditions of 2-8°C. Keep the container sealed under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 97.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%
Acetic Acid Content (HPLC)	Contact for details
Peptide Content (UV)	≥ 80.0%
Bacterial Endotoxins	< 10 EU/mg
Microbial Limit	Conforms to EP/USP

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.