Exenatide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist and peptide-based active pharmaceutical ingredient (API) used in the management of type 2 diabetes mellitus. It is structurally related to exendin-4, a peptide originally identified in the venom of the Gila monster.
Exenatide enhances glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion and slows gastric emptying, helping improve glycemic control.
Exenatide is a 39-amino-acid peptide that activates the GLP-1 receptor. Unlike native human GLP-1, it has greater resistance to degradation by the enzyme DPP-4, allowing it to exert a longer-lasting pharmacological effect.
CAS Number: 141732-76-5
Molecular Formula: C₁₈₄H₂₈₂N₅₀O₆₀S
Molecular Weight: Approximately 4186.6 g/mol
Exenatide binds to and activates GLP-1 receptors on pancreatic beta cells and other tissues involved in glucose regulation.
Its pharmacological effects include:
Exenatide is used in pharmaceutical formulations for:
Exenatide is not indicated for the treatment of type 1 diabetes mellitus.
Exenatide is a peptide-based biological API rather than a conventional small-molecule API. Pharmaceutical-grade material requires careful control of peptide identity, purity, potency and process-related impurities.
Typical quality evaluation may include:
Pharmaceutical-grade Exenatide should be manufactured under appropriate peptide/biopharmaceutical GMP controls and according to the applicable approved specification and regulatory requirements.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS where applicable, batch traceability and relevant regulatory documentation.
Exenatide drug substance and finished formulations require controlled storage conditions because peptide molecules can be sensitive to temperature, light, moisture and physical stress. Storage conditions should follow the approved manufacturer's specification.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |