Liraglutide is a synthetic peptide analogue of human glucagon-like peptide-1 (GLP-1) and belongs to the GLP-1 receptor agonist class. It is designed to mimic the activity of endogenous GLP-1 and is used in pharmaceutical formulations for the management of type 2 diabetes mellitus and obesity, according to the approved indication and formulation.
Liraglutide has a structure closely related to human GLP-1, with modifications that extend its duration of action. The molecule contains a fatty-acid side chain that promotes reversible binding to albumin, contributing to its prolonged pharmacological activity.
Liraglutide is a synthetic peptide containing 31 amino acids and has the molecular formula C172H265N43O51. Its molecular weight is approximately 3751.20 g/mol. The CAS Number is 204656-20-2.
As a peptide API, liraglutide requires specialized manufacturing, purification and analytical controls to ensure identity, purity, peptide integrity and appropriate biological activity.
Liraglutide selectively activates the GLP-1 receptor, a receptor involved in glucose-dependent insulin secretion and regulation of appetite and gastric emptying.
GLP-1 receptor activation increases insulin secretion when blood glucose is elevated, suppresses inappropriate glucagon secretion and slows gastric emptying. It also acts on appetite-regulating pathways, contributing to reduced food intake and body-weight reduction.
Liraglutide is used in approved pharmaceutical formulations for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise. At appropriate approved doses, it is also used for chronic weight management in eligible patients.
The exact indications, strengths and age restrictions depend on the specific product and regulatory jurisdiction.
Liraglutide API requires comprehensive peptide-specific analytical characterization. Testing may include identity confirmation, peptide content/assay, purity, related peptides, degradation products, residual solvents, water content, elemental impurities and other applicable quality attributes.
Analytical characterization can involve HPLC/UPLC, mass spectrometry, peptide mapping and other suitable techniques. Appropriate assessment of peptide-related impurities, oxidation, deamidation, aggregation and other degradation pathways is important for peptide APIs.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant regulatory requirements.
Liraglutide should be stored under controlled pharmaceutical conditions appropriate for a peptide API. Protection from excessive heat, moisture and light is important, and temperature excursions should be avoided.
Specific storage, handling and transportation conditions should follow the applicable manufacturer's approved specification.
Liraglutide (Synthetic) API may be supplied for qualified pharmaceutical manufacturing, peptide formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Liraglutide (Synthetic) API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 2.0% |