Semaglutide

Overview

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist with proven efficacy in glycemic control and weight management. As a long-acting GLP-1 analog, it provides sustained therapeutic effects with once-weekly administration. Our pharmaceutical-grade compounded formulation is manufactured in an FDA-registered 503B facility under strict cGMP conditions, providing healthcare professionals with a reliable source of high-quality semaglutide for their patients.

Mechanism of Action

Semaglutide is a GLP-1 receptor agonist that mimics the action of endogenous GLP-1, a hormone that regulates glucose homeostasis and appetite. Upon binding to GLP-1 receptors, semaglutide stimulates glucose-dependent insulin secretion from pancreatic beta cells, suppresses inappropriate glucagon secretion, and slows gastric emptying. Additionally, it acts on central nervous system pathways to reduce appetite and food intake. The peptide includes structural modifications that provide resistance to degradation by dipeptidyl peptidase-4 (DPP-4) and extend its half-life to approximately one week.

Pharmacology

• GLP-1 receptor agonism: 94% homology to native human GLP-1 with enhanced stability
• Extended half-life: Approximately 7 days, supporting once-weekly dosing
• Glucose-dependent mechanism: Insulin secretion occurs only when glucose is elevated
• Gastric motility effects: Delays gastric emptying, promoting satiety
• Central appetite suppression: Reduces hunger signals in hypothalamic centers
• Cardiovascular benefits: May provide cardioprotective effects beyond glycemic control
• Renal safety: Appropriate for use in patients with mild to moderate renal impairment

Stability & Storage

• Storage temperature: 2-8°C (36-46°F) - refrigeration required
• Light protection: Store in original container to protect from light exposure
• Stability studies: Conducted per ICH guidelines with validated analytical methods
• Beyond-use date: Assigned based on comprehensive stability data for each batch
• Room temperature stability: Limited stability data available for temporary excursions
• Freeze-thaw sensitivity: Do not freeze; freezing may compromise peptide integrity

Testing & Release Criteria

• Sterility testing: USP <71> - Comprehensive sterility assurance for every batch
• Bacterial endotoxin testing: USP <85> - LAL methodology ensuring pyrogenicity compliance
• Potency determination: HPLC with UV detection confirming 95-105% of labeled claim
• Identity confirmation: Mass spectrometry and peptide mapping for structural verification
• pH measurement: Verified within specification range for subcutaneous administration
• Sub-visible particulate matter: USP <788> - Light obscuration and microscopic analysis
• Container closure integrity testing: Ensures maintenance of sterility throughout shelf life
• Related substances: HPLC analysis for degradation products and impurities
• Osmolality testing: Verified for patient comfort and safety