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Irbesartan

CAS Number
138402-11-6
EC Number
604-078-2
Chemical Formula
C25H28N6O
Molecular Weight
428.5 g/mol

Description

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. Contact us for supply of Irbesartan Request Quote

Other Names (Synonyms)

Avapro | Aprovel | Karvea | Irbesartan BMS | SR 47436 | Irbesartan Zentiva | 2-Butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Melting Point180-181 °C
Boiling Point648.6±65.0 °C(Predicted)
Density0.45 g/cm³ (powder) (bulk)
AppearanceCrystalline Solid
Colorwhite to off-white
Formpowder

Safety & Handling

Danger
GHS07· IrritantGHS08· Health Hazard

Hazard Statements

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
H360May damage fertility or the unborn child
H361Suspected of damaging fertility or the unborn child
H362May cause harm to breast-fed children
H372Causes damage to organs through prolonged or repeated exposure
H412Harmful to aquatic life with long lasting effects

Precautionary Statements

P203Obtain, consult and follow expert instructions for use.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P263Avoid contact during pregnancy and while nursing.
P264Wash … thoroughly after handling.
P270Do not eat, drink or smoke when using this product.
P271Use only outdoors or in a well-ventilated area.
P273Avoid release to the environment.
P280Wear protective gloves/protective clothing/eye protection/face protection.
P318IF exposed or concerned, get medical advice.
P319Get medical advice/attention if you feel unwell.
P321Specific treatment (see … on this label).
P405Store locked up.
P501Dispose of contents/container in accordance with local regulations.
P265Wash … thoroughly after handling.
P352IF ON SKIN: Wash with plenty of water.
P340IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P317Get emergency medical help.
P317If eye irritation persists: Get medical advice/attention. Get emergency medical help.
P364Take off contaminated clothing and wash it before reuse.
P233Store in a well-ventilated place. Keep container tightly closed.
P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Trade & Regulatory

HS Code29332900
Storage Class11 - Combustible Solids
WGK (Germany)3