Description

Irbesartan13 is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 8402-11-6. This compound is critical for research, development, and quality control processes within the pharmaceutical industry, ensuring the efficacy and safety of final drug products. It is primarily required by manufacturers and R&D laboratories engaged in the production and analysis of cardiovascular medications and related active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of the antihypertensive drug Irbesartan and its analogs.
• Reference Standard: Used for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Research & Development: Serves as a crucial material for pharmacological studies and the development of new angiotensin II receptor antagonists.
• Impurity Profiling: Employed as a marker or standard to identify and quantify related substances in API batches.
• Regulatory Submissions: Provides essential data for drug master files (DMFs) and regulatory compliance documentation.

Basic Information

Product Name	Irbesartan13
CAS No.	8402-11-6
Molecular Formula	C25H28N6O
Molecular Weight	428.53 g/mol
Synonyms	Irbesartan Impurity 13; 2-Butyl-3-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one; BMS 186295 Impurity; SR 47447 Impurity; 1,3-Diazaspiro[4.4]non-1-en-4-one, 2-butyl-3-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-; Irbesartan Related Compound C
EINECS	Contact for details

Quality Control

Our Irbesartan13 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent specifications. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Loss on Drying	≤ 0.5%

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