Product Overview
This Semaglutide API is a synthetic GLP-1 receptor agonist produced via optimized Solid-Phase Peptide Synthesis (SPPS). We provide this high-purity API to pharmaceutical companies, CDMOs, and research institutions for use in clinical trials and commercial dosage manufacturing. Our manufacturing process focuses on rigorous control of peptide chain extension and standardized purification, ensuring batch-to-batch reproducibility and strict alignment with global regulatory requirements for pharmaceutical development.
Technical Quality Standards
We prioritize process control to ensure formulation stability and minimize downstream purification requirements.
Purity Control: Achieves ≥99% HPLC purity. Our synthesis process specifically controls for common peptide impurities (e.g., truncated peptides and diastereomers) to ensure consistent quality across all batches.
Molecular Verification: Every batch undergoes LC-MS analysis to confirm the molecular weight (C187H291N45O59, ~4113.6 Da) and sequence integrity, ensuring compliance with global documentation standards.
Impurity & Solvent Management: Production strictly adheres to ICH Q3C and pharmacopeial guidelines. We monitor and control residual solvents and specific impurities to mitigate quality risks in your final formulation.
Process Stability: We utilize fixed production parameters, validated equipment, and standardized SOPs. By locking in critical process parameters (CPP), we ensure that the impurity profile and chemical characteristics remain consistent from pilot to commercial-scale batches.
Production Environment: Operations are conducted in fully validated, GMP-compliant facilities. We maintain full transparency and welcome client-led supplier qualification and on-site quality audits.
Technical Specifications
|
Item |
Specification |
|
Product Name |
Semaglutide Peptide API |
|
Appearance |
White to off-white lyophilized powder |
|
Purity (HPLC) |
≥99% |
|
Identification |
LC-MS |
|
Molecular Formula |
C187H291N45O59 |
|
Molecular Weight |
~4113.6 Da |
|
Manufacturing Method |
Solid-Phase Peptide Synthesis (SPPS) |
|
Storage Conditions |
-20°C, protected from light and moisture |
Regulatory Documentation & Partnership
We provide a comprehensive documentation package to support your procurement and regulatory filings:
Analytical Documentation: Certificate of Analysis (COA), HPLC chromatogram, and LC-MS report.
Compliance Support: Certificate of Origin (COO), Safety Data Sheet (SDS), and detailed Product Specification.
Traceability: Technical Data Sheet (TDS) and full batch traceability records provided upon request.
Scalability: We support project growth from pilot-scale research to long-term commercial bulk procurement.
Global Logistics: We utilize moisture-proof, vacuum-sealed, and light-protective packaging. Our team possesses extensive expertise in global cold-chain logistics, ensuring product stability and seamless customs clearance for international transit.
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