Azilsartan CAS 147403-03-0
Azilsartan — a second-generation highly selective AT₁ receptor antagonist antihypertensive API — comes as a white to off-white crystalline powder. It offers high receptor affinity and 24-hour sustained efficacy, making it ideal for oral solid dosage development and manufacturing. UATChem supplies pharmaceutical-grade azilsartan with strict impurity management and consistent batch quality, supporting generic R&D, BE studies and full commercial production. Full compliance documents including COA, TDS, SDS and traceability records accompany every shipment.
- CAS No: 147403-03-0
- Synonyms: Azilsartan free acid; TA-606
- EC Number: Not assigned
- Molecular Formula: C₂₅H₂₀N₄O₅
- Molecular Weight: 456.45 g/mol
- Appearance: White to off-white crystalline powder
- Purity (HPLC): ≥ 99.5%
- Single Impurity Limit: ≤ 0.1%
- Packaging: 1 kg aluminum foil bag; 25 kg fiber drum with PE liner. Custom options available.
- Primary Uses: Antihypertensive oral APIs, generic drug R&D, pharmaceutical intermediate synthesis
Core Product Information
Azilsartan falls into the angiotensin II receptor blocker category of antihypertensive compounds. It works by selectively binding to AT₁ receptors on vascular smooth muscle and adrenal tissue, blocking the vasoconstrictive and aldosterone-releasing effects of angiotensin II. The unique oxadiazolone ring in its molecular structure increases receptor affinity and extends duration of action, supporting once-daily dosing with steady 24-hour blood pressure control.
UATChem’s pharmaceutical-grade azilsartan is produced through controlled multi-step synthesis followed by precision purification. We apply tight controls over related substances, residual solvents and elemental impurities across every batch. We also standardize crystal form and particle size distribution to support consistent dissolution performance across production runs.
Quality Control Specifications
| Test Item | Acceptance Criteria |
|---|---|
| Assay (HPLC, anhydrous basis) | ≥ 99.5% |
| Total related substances | ≤ 0.5% |
| Single maximum impurity | ≤ 0.1% |
| Water content (Karl Fischer) | ≤ 0.5% |
| Residue on ignition | ≤ 0.1% |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Arsenic | ≤ 3 ppm |
Typical End Uses
Oral solid dosage manufacturing
Serves as the active ingredient in immediate-release tablets and capsules for primary hypertension treatment. It also works in fixed-dose combination products paired with diuretic actives like chlorthalidone.
Generic drug development & regulatory filing
Fits well for generic formulation R&D, bioequivalence studies and ANDA submission programs. Consistent material properties from batch to batch reduce development variables and help shorten time to market.
Pharmaceutical intermediate applications
Acts as a starting material for synthesizing azilsartan ester prodrugs and other ARB derivative compounds in pharmaceutical R&D settings.
Packaging, Storage & Handling
For long-term storage, keep material in tightly sealed, light-resistant containers at 2–8 °C. Short-term handling and standard transit can take place at ambient temperatures below 25 °C. Protect material from moisture, direct sunlight and strong oxidizing agents to prevent degradation and impurity buildup.
UATChem offers two standard packaging options: 1 kg vacuum-sealed aluminum foil bags for lab testing and small-batch trials, and 25 kg fiber drums with food-grade PE liners for commercial-scale manufacturing. Custom packaging sizes and tailored particle size fractions are available upon request.
Material classifies as non-hazardous for standard ocean and air freight. Keep original packaging intact during transit to avoid contamination and moisture exposure. All shipments include a current Certificate of Analysis with full test results. Verify assay and impurity profile on receipt before releasing material for production use.
Frequently Asked Questions
Q: What crystal form does your azilsartan API have?
A: Our standard grade is the stable crystalline form most commonly used in oral solid formulations. Specific polymorphic forms are available on request for formulation development projects.
Q: Is this material suitable for modified-release dosage forms?
A: Yes. It shows good chemical stability across a wide pH range, and works for both immediate-release and sustained-release solid dosage forms including matrix tablets and pellet formulations.
Q: Do you provide residual solvent and microbial test data?
A: Yes. Every batch comes with a full COA covering residual solvents, heavy metals and related substances. Additional microbial limit test reports are available on request.
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