Overview
Irbesartan (CAS 138402-11-6 ), also referenced under development codes BMS-186295 and marketed as Avapro and Aprovel, is an angiotensin II receptor antagonist API used in the manufacture of antihypertensive drug products.
It is a primary active pharmaceutical ingredient sourced by generic drug manufacturers and contract formulators worldwide. Irbesartan is the core API in finished oral solid dosage forms, such as tablets and capsules.
These finished products target hypertension and diabetic nephropathy indications. Generic pharmaceutical manufacturers source it in bulk to produce bioequivalent formulations following patent expiry in major markets.
Contract development and manufacturing organizations (CDMOs) use it in combination product development, particularly fixed-dose combinations with hydrochlorothiazide. This is a common practice in the industry.
Regulatory dossier preparation and reference standard procurement represent additional sourcing contexts for QA and analytical laboratories. Irbesartan is supplied as a white to off-white crystalline powder.
Quantities range from laboratory scale to multi-tonne commercial lots. It is available to USP , Ph. Eur. , and BP specifications, with ICH-compliant impurity profiling expected for GMP-grade material.
Certificate of Analysis, DMF references, and country-specific regulatory support documentation are standard requirements at the commercial supply level. These documents ensure compliance with global safety standards.
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Physical Properties
| Melting Point | 180-181 °C |
| Boiling Point | 648.6±65.0 °C(Predicted) |
| Density | 0.45 g/cm³ (powder) (bulk) |
| Appearance | Crystalline Solid |
| Color | white to off-white |
| Form | powder |
Safety & Handling
Danger GHS07 GHS08 Hazard Statements H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation H360 May damage fertility or the unborn child H361 Suspected of damaging fertility or the unborn child H362 May cause harm to breast-fed children H372 Causes damage to organs through prolonged or repeated exposure H412 Harmful to aquatic life with long lasting effects Precautionary Statements P203 Obtain, consult and follow expert instructions for use. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P263 Avoid contact during pregnancy and while nursing. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. P318 IF exposed or concerned, get medical advice. P319 Get medical advice/attention if you feel unwell. P321 Specific treatment (see … on this label). P405 Store locked up. P501 Dispose of contents/container in accordance with local regulations. P264+P265 Wash … thoroughly after handling. P302+P352 IF ON SKIN: Wash with plenty of water. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P332+P317 Get emergency medical help. P337+P317 If eye irritation persists: Get medical advice/attention. Get emergency medical help. P362+P364 Take off contaminated clothing and wash it before reuse. P403+P233 Store in a well-ventilated place. Keep container tightly closed. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Trade & Regulatory
| HS Code | 29332900 |
| Storage Class | 11 - Combustible Solids |
| WGK (Germany) | 3 |
Other Names
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Chemical Properties
- CAS Number
- 138402-11-6
- EC Number
- 604-078-2
- Mol. Weight
- 428.5
- HS Code
- 29332900
- Category
- Pharmaceutical Intermediates