Development materials, batch quality documentation, DMF-related support and approximately -18°C cold-chain coordination for pharmaceutical companies, CDMOs and research teams.
Ureda Pharma supports pharmaceutical manufacturers, CDMO/CMO organizations, formulation teams and API sourcing professionals with Semaglutide API and related technical documentation. Oral-related and injection-related development materials can be discussed according to the intended dosage form, development phase and target market.
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Semaglutide API is the active pharmaceutical ingredient used in pharmaceutical research, formulation development and drug manufacturing. It is a long-acting GLP-1 receptor agonist and a structurally complex peptide API.
Its molecular design improves resistance to DPP-4 degradation, increases albumin binding and extends the duration of action. Quality evaluation therefore extends beyond assay and includes molecular identity, peptide structure, related substances, residual solvents, aggregates, microbial quality and biological activity.
| Item | Information |
|---|---|
| Product Name | Semaglutide |
| CAS Number | 910463-68-2 |
| Molecular Formula | C187H291N45O59 |
| Molecular Weight | 4113.58 g/mol |
| Product Type | Peptide API |
| Appearance | White powder |
| Solubility | Freely soluble in water |
| Available Materials | Oral-related and injection-related development materials |
| Storage | Low-temperature storage |
| Transportation | Approximately -18°C cold-chain transportation |
Oral-related materials may support formulation screening, dissolution studies, stability evaluation, analytical method development and process feasibility studies. The following representative data are for preliminary technical evaluation; final specifications and batch results must be confirmed for the material offered.
| Test Item | Representative Result |
|---|---|
| Appearance | White powder |
| Solubility | Freely soluble in water |
| HPLC Identity | Conforms |
| Mass Spectrometry | 4111.1 Da |
| Peptide Mapping | Conforms |
| Water Content | 5.2% |
| pH | 7.0 |
| Particle Size D90 / D50 / D10 | 28 μm / 13 μm / 4 μm |
| Total Related Substances | 0.78% |
| HMW Protein | <0.05% |
| Residual Solvents | Not detected |
| Semaglutide Assay | 98.0% |
Injection-related materials require particular attention to product-related and process-related impurities, aggregates, endotoxins, microbial limits, residual solvents and biological activity. They may be considered for formulation screening, solution stability studies, analytical method development and injectable process evaluation.
| Test Item | Representative Result |
|---|---|
| Total Process-related Impurities | 0.1% |
| Total Product-related Impurities | 0.5% |
| HMW Protein | 0.0% |
| Residual Solvents | Not detected / <LOQ |
| Bacterial Endotoxins | <10 EU/mg |
| TAMC / TYMC | <1 cfu/g / <1 cfu/g |
| Host Cell Protein | Not detected |
| Relative Biological Potency | 92% |
| Protein Content | 0.93 mg/mg |
Depending on the selected product, batch and project requirements, available support may include Batch COA, product specification, analytical-method information, SDS, TDS, stability-related information, DMF-related documentation and QA/QC/RA technical communication. The documentation scope should be confirmed for the target market and project stage.
Semaglutide is a temperature-sensitive peptide API. Ureda Pharma can help coordinate low-temperature packaging, air freight, transit-time planning, temperature monitoring, shipment tracking, customs-clearance support and delivery according to the destination and shipment requirements.
No. It is an active pharmaceutical ingredient intended for pharmaceutical research, formulation development and drug manufacturing, not a finished medicine for direct consumer sale.
Both directions can be discussed according to intended use, project requirements, quality targets and documentation needs.
Depending on the product and batch, documents may include specification, Batch COA, analytical data, SDS, TDS, stability information and DMF-related support.
Semaglutide is temperature sensitive and generally requires controlled low-temperature handling. Approximately -18°C cold-chain transportation can be coordinated according to the shipment and destination.
If you are looking for a Semaglutide API supplier, oral-related or injection-related development materials, DMF documentation support or a low-temperature transport solution, contact Ureda Pharma with your project requirements.
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