Product Overview
Semaglutide is a synthetic analog of human glucagon-like peptide-1 (GLP-1) containing 31 amino acids with two key structural modifications: an aminoisobutyric acid (Aib) substitution at position 8 for DPP-4 resistance, and a C-18 fatty diacid chain linked to lysine-26 via a glutamic acid spacer. This design enables prolonged albumin binding and a half-life of approximately one week.
As a raw material supplier, we provide Semaglutide in its lyophilized powder form, suitable for downstream pharmaceutical manufacturing. Our API is produced via solid-phase peptide synthesis (SPPS) followed by preparative HPLC purification, controlled cleavage, and lyophilization to ensure batch-to-batch consistency.
This product is an active pharmaceutical ingredient (API) intended for use as a raw material in drug formulation. It is not a finished dosage form and is not intended for direct patient use.
Key Features
- High purity ≥98.5% by HPLC, with detailed impurity profiling
- Manufactured under cGMP in validated production facilities
- Consistent batch-to-batch quality with full traceability
- Lyophilized powder format for long-term stability
- Scalable supply from gram-level R&D to commercial bulk quantities
- Cold-chain logistics with real-time temperature monitoring
Applications
Semaglutide API from our facility is used across a range of pharmaceutical development programs:
Injectable Formulations
Subcutaneous injection products designed for once-weekly dosing. Compatible with prefilled syringe and pen device development workflows.
Oral Dosage Forms
For oral Semaglutide tablet development using permeation enhancer co-formulation technology. Our API particle characteristics are optimized for oral processing.
Generic / ANDA Development
Reference-listed drug quality API for bioequivalence study programs. Supported by comparative analytical data and regulatory documentation.
Preclinical & Research
Research-grade supply available for mechanism-of-action studies, pharmacology research, and academic investigations into GLP-1 biology.
Specifications
| Product Name | Semaglutide |
| Synonyms | Semaglutide; NN9535 |
| CAS Number | 910463-68-2 |
| Amino Acid Sequence | 31-mer GLP-1 analog with Aib⁸ and C-18 fatty diacid side chain at Lys²⁶ |
| Molecular Formula | C₁₈₇H₂₉₁N₄₅O₅₉ |
| Molecular Weight | 4,113.64 g/mol |
| Appearance | White to off-white lyophilized powder |
| Purity (HPLC) | ≥ 98.5% |
| Largest Single Impurity | ≤ 0.5% |
| Peptide Content | ≥ 80.0% (anhydrous, acetate-free basis) |
| Water Content | ≤ 8.0% (Karl Fischer) |
| Acetic Acid Content | ≤ 10.0% |
| Endotoxin | ≤ 5.0 EU/mg |
| Sterility | Meets requirements (sterile filtration applied) |
| Specific Optical Rotation | -60.0° to -70.0° |
| Storage | -20°C, protect from light and moisture |
| Shelf Life | 36 months under recommended conditions |
| Grade | GMP Commercial / Research (upon request) |
| Regulatory | ICH Q7 compliant; DMF support available |
Available Documentation
We provide a comprehensive documentation package to support your regulatory submissions and quality assurance processes:
- Certificate of Analysis (COA) — per batch
- Drug Master File (DMF) — Letter of Authorization available
- Stability data (ICH accelerated and long-term)
- Elemental impurity report (ICH Q3D)
- Residual solvent report (ICH Q3C)
- Amino acid analysis report
- Mass spectrometry confirmation (ESI-MS)
- Process flow diagram and general synthetic route
- TSE/BSE certificate
Packaging & Shipping
Semaglutide API is packaged under inert atmosphere in amber glass vials or HDPE containers, sealed with PTFE-lined closures. Each unit is labeled with product name, batch number, net weight, storage conditions, and expiry date.
All shipments are dispatched via validated cold-chain carriers with continuous temperature data logging. We offer door-to-door delivery globally with full customs documentation support including Certificate of Origin, commercial invoice, and MSDS.
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