Irbesartan

CAS Number

138402-11-6

EC Number

604-078-2

What is Irbesartan?

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.

Where is Irbesartan used?

Generic drug manufacturers and contract formulators: primary API for bioequivalent formulations after patent expiry
Oral solid dosage forms: core API in tablets and capsules for hypertension and diabetic nephropathy
CDMOs: combination product development, particularly fixed-dose combinations with hydrochlorothiazide
QA and analytical laboratories use it for regulatory dossier preparation and reference standard procurement.

Commercial specifications

Quantities from laboratory scale to multi-tonne commercial lots
USP, Ph. Eur. and BP specifications; ICH-compliant impurity profiling for GMP-grade material
Certificate of Analysis, DMF references and country-specific regulatory support documentation

Other Names (Synonyms)

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What are the physical properties of Irbesartan?

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

How is Irbesartan classified and handled safely? Learn More

Danger

GHS07· Irritant GHS08· Health Hazard

Hazard Statements

H315 Causes skin irritation

H319 Causes serious eye irritation

H335 May cause respiratory irritation

H360 May damage fertility or the unborn child

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.

Which trade and regulatory codes apply to Irbesartan?

HS Code 29332900

Storage Class 11 - Combustible Solids

WGK (Germany) 3