Semaglutide API Supplier
CAS 910463-68-2 · 4113.58 g/mol
WinHyCare supplies Semaglutide API (CAS 910463-68-2), a 31-amino-acid acylated GLP-1 receptor agonist, to pharmaceutical, generic and research customers. We source material delivering ≥99% purity by SPPS, with full impurity control, US-DMF / CTD Module 3 documentation and validated cold-chain export — for B2B pharmaceutical manufacturing and R&D use.
- CAS Number
- 910463-68-2
- Molecular Formula
- C187H291N45O59
- Molecular Weight
- 4113.58 g/mol
- Drug Class
- GLP-1 receptor agonist (acylated 31-amino-acid peptide)
What is Semaglutide API?
Semaglutide is a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist — a 31-amino-acid peptide based on the human GLP-1(7-37) backbone, structurally modified for extended half-life. Two substitutions (Aib at position 8 and Arg at position 34) plus acylation with a C18 fatty di-acid attached through a γGlu-2×OEG linker give the molecule strong albumin binding and resistance to DPP-4 degradation, supporting once-weekly dosing.
As an active pharmaceutical ingredient (API), semaglutide (CAS 910463-68-2, molecular formula C187H291N45O59, ~4113.58 g/mol) is supplied as a lyophilised powder for formulation into injectable and oral finished dosage forms. It is one of the highest-demand peptide APIs globally, driven by its use in type 2 diabetes and chronic weight-management therapies. WinHyCare supplies this API strictly on a B2B basis to licensed pharmaceutical manufacturers, formulation developers and research organisations.
WinHyCare as your Semaglutide API supplier
Semaglutide is a synthetically challenging acylated peptide: the lipid side-chain conjugation, the Aib residue and the 31-mer length all create opportunities for deletion sequences, diastereomers and incomplete acylation. WinHyCare supplies semaglutide produced to demanding standards — by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled side-chain conjugation, then purified on preparative dynamic axial compression (DAC) HPLC columns to isolate the target sequence sharply from closely related impurities.
The material is sourced to a specification that ensures repeatable batch-to-batch consistency from optimisation runs through kilogram and multi-kilogram commercial campaigns, with lyophilisation to a stable, uniform API powder. As a CRDMO sourcing partner we also coordinate process development, technology transfer and scale-up support so customers can move from clinical to commercial supply through a single, audit-ready source.
Quality specifications & impurity control
Each batch is released against a defined specification with a Certificate of Analysis (COA). Purity is determined by UPLC/HPLC and the sequence and minor structural variants are confirmed by LC-MS impurity profiling. Our target release purity is ≥99.0%, with individual impurities controlled strictly below 0.10%, supported by ICH Q1A(R2) long-term and accelerated stability data.
Full traceability is maintained from raw materials and resins through to final batch-release records. Analytical methods are validated to ICH Q2(R1), and water content, acetate/counter-ion content, residual solvents and peptide content are characterised so the API is ready for regulated formulation development.
Regulatory & documentation support (US-DMF / CTD Module 3)
WinHyCare provides the documentation customers need to file with their own submissions and to streamline global regulatory review. For semaglutide we support US-DMF Type II dossiers, CTD Module 3 CMC sections (for IND/NDA/ANDA referencing), analytical validation packages to ICH Q2(R1), and stability data with SOP access.
A dedicated B2B support desk helps resolve deficiency letters, regulator information requests and customer QA queries during filing. The supplied material is backed by quality systems built around pre-approval-inspection (PAI) readiness aligned to FDA, EMA and PMDA expectations, reducing review cycles and supporting faster approval of the customer's finished product.
Packaging, cold-chain export & custom synthesis
Semaglutide API is packaged under controlled, low-temperature conditions and shipped via validated cold-chain logistics with active temperature monitoring and customs documentation for the US, Europe and Asia. Standing supply agreements, safety-stock reserves and flexible delivery scheduling keep customer production lines running.
Beyond catalogue supply, we offer custom synthesis and made-to-order quantities — including isotope-free reference standards, specified salt forms and tailored purity grades — to match exact client requirements. Quotations, COA, and regulatory documentation are provided on request; minimum order quantities are agreed per programme.
Semaglutide API — Specifications
| Compound | Semaglutide |
|---|---|
| CAS Number | 910463-68-2 |
| Molecular Formula | C187H291N45O59 |
| Molecular Weight | 4113.58 g/mol |
| Sequence | 31 amino acids, acylated (C18 di-acid side chain) |
| Drug Class | GLP-1 receptor agonist |
| Appearance | White to off-white lyophilised powder |
| Purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis | Fmoc SPPS + DAC prep-HPLC purification |
| Documentation | COA, US-DMF Type II, CTD Module 3 support |
| Storage | Store at -20°C, protected from light & moisture |
| Use | B2B — pharmaceutical manufacturing & R&D only |
For B2B pharmaceutical manufacturing and R&D use only. WinHyCare does not sell APIs to individuals or for direct human consumption. Regulatory status: Approved as an active ingredient by major regulators including the US FDA and EMA for type 2 diabetes and chronic weight management.
Semaglutide API — Frequently Asked Questions
What is the CAS number and molecular weight of Semaglutide?
Semaglutide's CAS number is 910463-68-2, its molecular formula is C187H291N45O59, and its molecular weight is approximately 4113.58 g/mol. It is a 31-amino-acid GLP-1 receptor agonist acylated with a C18 fatty di-acid side chain.
What purity grade does WinHyCare's Semaglutide API meet?
Our target release purity is ≥99.0% by UPLC/HPLC, with individual impurities controlled below 0.10%, confirmed by LC-MS impurity profiling and supported by ICH stability data. Each batch ships with a Certificate of Analysis.
Do you provide US-DMF and CTD Module 3 support for Semaglutide?
Yes. We support US-DMF Type II dossiers and CTD Module 3 CMC documentation, plus ICH Q2(R1) analytical validation packages and stability data, to help customers file IND/NDA/ANDA submissions and streamline regulatory review.
How is Semaglutide API produced?
It is produced by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled lipid side-chain conjugation, followed by preparative dynamic axial compression (DAC) HPLC purification and lyophilisation to a stable powder, in kilogram to multi-kilogram campaigns. WinHyCare supplies material meeting these standards.
What is the minimum order quantity and lead time?
Minimum order quantity and lead time are agreed per programme depending on grade, quantity and documentation scope. Share your specification and target volume and our team will confirm pricing, MOQ and a delivery schedule.
Can WinHyCare supply Semaglutide as a reference standard or custom grade?
Yes. Beyond standard API supply we provide custom synthesis, specified salt forms, tailored purity grades and reference-standard quantities to match exact client requirements.
How is Semaglutide API shipped and stored?
It is supplied as a lyophilised powder, stored at -20°C protected from light and moisture, and shipped via validated cold-chain logistics with active temperature monitoring and customs documentation for the US, Europe and Asia.
Is this Semaglutide API sold to individuals?
No. WinHyCare supplies Semaglutide API strictly on a B2B basis to licensed pharmaceutical manufacturers, formulation developers and research organisations for pharmaceutical manufacturing and R&D — not for sale to individuals or for direct human consumption.
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Source Semaglutide API from WinHyCare
Request pricing, Certificate of Analysis, US-DMF / CTD Module 3 documentation and a cold-chain export quote. Custom synthesis and bulk quantities available.