Chemical Name：Semaglutide
Synonyms：Ozempic®, Wegovy®, Rybelsus® (brand names)
Molecular Formula：C<sub>187</sub>H<sub>291</sub>N<sub>45</sub>O<sub>59</sub>
Molecular Weight：~4113.58 g/mol
Appearance：White to off-white powder (lyophilized solid)
Solubility：Soluble in water (at specific pH)
Stability：Stable under recommended storage conditions (2–8°C for unopened vials/pens)
Mechanism of Action：GLP-1 receptor agonist (enhances insulin secretion, suppresses glucagon)
Half-life ~1 week (prolonged due to albumin binding)
Administration Route：Subcutaneous injection (Ozempic/Wegovy) or oral (Rybelsus)
Indications：Type 2 diabetes mellitus, chronic weight management (obesity/overweight)
Peak Plasma Time：1–3 days (subcutaneous)
Metabolism：Proteolytic cleavage (wide distribution)
Excretion Urine and feces
Chemical Structure Modified human GLP-1 analog (acyl side chain for prolonged action)
Semaglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist used to treat type 2 diabetes and obesity. It mimics the action of endogenous GLP-1, enhancing insulin secretion, suppressing glucagon, and slowing gastric emptying. Its unique structure includes a fatty acid side chain, enabling once-weekly dosing (injectable forms) or daily oral administration (Rybelsus®). Clinical trials demonstrate significant efficacy in glycemic control and weight loss.
| Test Item | Specification | Test Method | Acceptance Criteria |
|---|
| Appearance | White to off-white powder | Visual inspection | Complies |
| Identification | HPLC / Mass Spectrometry (MS) | USP/EP Chromatographic method | Retention time matches reference |
| Purity (HPLC) | ≥ 98.5% (or as per customer requirement) | HPLC (UV detection, C18 column) | 98.5% – 101.0% |
| Related Substances | Individual impurity ≤ 0.5%, Total ≤ 1.5% | HPLC | Meets ICH Q3A/B guidelines |
| Water Content (KF) | ≤ 5.0% | Karl Fischer titration | ≤ 5.0% |
| Residual Solvents | Complies with ICH Q3C | GC (Headspace) | Meets limits for Class 1/2/3 solvents |
| Heavy Metals | ≤ 10 ppm | ICP-MS / USP <231> | ≤ 10 ppm |
| Assay (Content) | 95.0% – 105.0% | HPLC / UV-Vis | Within specified range |
| Microbial Limits | Total aerobic count ≤ 100 CFU/g | USP <61> / EP 2.6.12 | Complies |
| Endotoxins | ≤ 10 EU/mg | LAL test (USP <85>) | ≤ 10 EU/mg |
| pH (Solution) | 7.0 – 8.5 (if applicable) | pH meter | As per formulation requirements |
| Sterility (if sterile) | Sterile | USP <71> (Membrane filtration) | No growth observed |
China
