Exendin-4 API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Exendin-4 API Manufacturer & Supplier in India

Exendin-4 is a naturally occurring 39-amino-acid peptide and a potent glucagon-like peptide-1 (GLP-1) receptor agonist. It was originally isolated from the saliva of the Gila monster (Heloderma suspectum) and served as the structural basis for the development of exenatide.

Exendin-4 binds to GLP-1 receptors and produces glucose-dependent effects on insulin and glucagon secretion, as well as effects on gastric emptying and appetite regulation.

What is Exendin-4?

Exendin-4 is a peptide that shares functional similarity with human GLP-1 but is more resistant to degradation by dipeptidyl peptidase-4 (DPP-4). It is widely used as a research and pharmaceutical-development peptide and is the parent peptide of exenatide.

CAS Number: 141732-76-5
Molecular Formula: C₁₈₄H₂₈₂N₅₀O₆₀S
Molecular Weight: Approximately 4186.6 g/mol

Mechanism of Action

Exendin-4 activates the GLP-1 receptor, a G-protein-coupled receptor involved in glucose homeostasis.

Its pharmacological effects include:

  • Activation of GLP-1 receptors
  • Glucose-dependent stimulation of insulin secretion
  • Suppression of inappropriate glucagon secretion
  • Delayed gastric emptying
  • Reduction in food intake
  • Improvement of glucose regulation

Pharmaceutical & Research Applications

Exendin-4 is used in:

  • GLP-1 receptor research
  • Diabetes and metabolic research
  • Drug discovery and development
  • Peptide-based therapeutic research
  • Investigation of glucose and insulin signaling
  • Development and characterization of GLP-1 receptor agonists

Note: Exendin-4 itself should not be presented as an approved therapeutic product unless the specific formulation and indication have received applicable regulatory approval. Exenatide is the approved therapeutic derivative based on Exendin-4.

Exendin-4 API / Peptide

Exendin-4 is a peptide active pharmaceutical ingredient / research peptide rather than a conventional small-molecule API. Pharmaceutical or research-grade material requires appropriate control of peptide identity, purity, related peptides and biological activity.

Typical quality evaluation may include:

  • Identification
  • Peptide content / assay
  • Purity
  • Related peptide impurities
  • Biological potency
  • Water content
  • Residual solvents
  • Residual reagents
  • Endotoxin
  • Microbial limits
  • Peptide aggregation, where applicable

Quality & Regulatory Considerations

Exendin-4 material should be manufactured according to the applicable GMP or research-grade quality requirements, depending on its intended use.

A qualified supplier may provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, chromatographic data, batch traceability and applicable analytical documentation.

Storage

Exendin-4 is a peptide and should be stored under controlled conditions appropriate to the material's formulation and stability data, with protection from excessive heat, moisture and other factors that may affect peptide stability.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
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