Liraglutide (Recombinant) API Manufacturer in India

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

Liraglutide (Recombinant) API

Liraglutide is a recombinant peptide analogue of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. It is a long-acting lipopeptide designed to mimic the activity of endogenous GLP-1 while providing prolonged receptor activity.

Liraglutide contains a GLP-1-derived peptide backbone with a C16 palmitoyl fatty-acid chain attached through a glutamic-acid spacer. This structural modification contributes to its prolonged pharmacological activity.

Liraglutide (Recombinant) API Manufacturer in India

Liraglutide (Recombinant) is a specialized peptide pharmaceutical API requiring controlled recombinant/biotechnological production, purification and extensive analytical characterization.

Critical quality attributes include identity, peptide purity, related peptides, aggregation, water content, residual solvents, peptide content and biological activity.

Chemical / Biological Information

CAS Number: 204656-20-2
Molecular Formula: C172H265N43O51
Molecular Weight: 3751 g/mol
Synonym: NN2211
Drug Class: GLP-1 Receptor Agonist
Therapeutic Class: Antidiabetic / Anti-obesity Agent
Molecule Type: Synthetic/Modified Peptide Lipopeptide
Therapeutic Area: Diabetes / Metabolic Disorders

Mechanism of Action

Liraglutide acts as an agonist of the GLP-1 receptor. GLP-1 receptor activation contributes to glucose-dependent stimulation of insulin secretion, suppression of inappropriate glucagon secretion and delayed gastric emptying.

Its prolonged activity compared with native GLP-1 results from structural modifications that increase resistance to enzymatic degradation and extend circulation time.

Pharmaceutical Applications

Liraglutide is associated with pharmaceutical formulations used for:

  • Type 2 diabetes mellitus
  • Glycemic control
  • Weight management
  • Obesity management
  • GLP-1 receptor agonist research
  • Metabolic disease research

Structural Characteristics

Liraglutide is derived from human GLP-1 and contains specific structural modifications, including:

  • Amino-acid substitution at position 28
  • Palmitoylation
  • Glutamic-acid spacer
  • Extended peptide stability

The resulting lipopeptide has a molecular weight of approximately 3.75 kDa.

Manufacturing Process

A controlled recombinant/peptide manufacturing process may include:

  1. Preparation of qualified biological or peptide starting materials
  2. Controlled peptide/recombinant production
  3. Intermediate recovery
  4. Purification
  5. Chromatographic separation
  6. Palmitoylation / lipid modification where applicable
  7. Removal of process-related impurities
  8. Final purification
  9. Concentration
  10. Lyophilization or controlled drying
  11. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical Liraglutide API testing may include:

  • Identification by LC-MS
  • Peptide mapping
  • HPLC purity
  • Related peptides
  • Assay / peptide content
  • Water content
  • Residual solvents
  • Host-cell protein, where applicable
  • Host-cell DNA, where applicable
  • Aggregates
  • Endotoxins
  • Microbiological quality
  • Biological activity
  • Stability testing

Storage

Store Liraglutide API under validated temperature and humidity conditions, protected from excessive heat, moisture and light. Because Liraglutide is a peptide, storage conditions should be based on the actual manufacturer's validated stability data and approved specification.

Pharmaceutical Research

Liraglutide is relevant to research involving:

  • GLP-1 receptors
  • GLP-1 receptor agonists
  • Type 2 diabetes
  • Obesity
  • Metabolic disorders
  • Insulin secretion
  • Glucose regulation
  • Peptide therapeutics
  • Long-acting peptide development
  • Metabolic disease drug development

Liraglutide (Recombinant) API Summary

Liraglutide is a long-acting GLP-1 receptor agonist peptide with CAS 204656-20-2, molecular formula C172H265N43O51, and molecular weight approximately 3751 g/mol. It is a modified GLP-1 analogue containing a palmitoyl group attached through a glutamic-acid spacer.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 95.0%
Loss on Drying NMT 5.0%
Water Content NMT 5.0%
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