Description

Irbesartan is a potent and selective angiotensin II receptor antagonist (ARB) used primarily as an active pharmaceutical ingredient (API). It is a critical component in the formulation of antihypertensive medications, effectively managing high blood pressure and offering renal protection in patients with type 2 diabetes. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and developers of generic drug formulations seeking reliable, compliant, and scalable API supply.

Application

• Pharmaceutical API: Primary use as the active ingredient in tablet and capsule formulations for the treatment of hypertension (high blood pressure).
• Cardiovascular Drug Manufacturing: Key component in medications aimed at reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy.
• Nephroprotective Formulations: Used in drugs for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension.
• Research & Development: Serves as a reference standard and starting material in pharmacological studies and the development of new cardiovascular therapies.
• Generic Drug Production: Essential for manufacturers producing bioequivalent versions of branded irbesartan medications.
• Combination Therapies: Used in fixed-dose combination drugs, often paired with hydrochlorothiazide or other antihypertensive agents.

Basic Information

Product Name	Irbesartan
CAS No.	138402-11-6
Molecular Formula	C25H28N6O
Molecular Weight	428.53 g/mol
Synonyms	2-Butyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one; BMS-186295; SR 47436; Avapro® (Brand Name); Karvea® (Brand Name); Approvel® (Brand Name); Irbesartanum; Irbesartanum
EINECS	Contact for details

Quality Control

Our Irbesartan API is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopoeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and other critical parameters to guarantee supply reliability and regulatory compliance for global markets.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Ensure the storage area is well-ventilated and away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF Titration)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with EP/USP

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.