Description

Irbesartan Related Compound A (25 Mg) (1-Pentanoylamino-Cyclopentanecarboxylic Acid [2'-(1H-Tetrazol-5-Yl)-Biphenyl-4-Ylmethyl]-Amide) is a high-purity reference standard and pharmaceutical impurity critical for ensuring the quality and safety of the active pharmaceutical ingredient (API) Irbesartan. This compound is essential for analytical method development, validation, and routine quality control testing in pharmaceutical manufacturing and regulatory compliance. It is primarily used by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the production and analysis of cardiovascular medications.

Application

• Pharmaceutical Impurity Profiling and Identification in Irbesartan API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Stability Studies and Forced Degradation Testing to monitor impurity formation over time.
• Quality Control (QC) and Release Testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Regulatory Submissions and Compliance, providing essential data for FDA, EMA, and other global health authority filings.
• Calibration Standard for quantitative analysis in pharmaceutical laboratories.
• Research and Development of generic Irbesartan formulations.

Basic Information

Product Name	Irbesartan Related Compound A (25 Mg) (1-Pentanoylamino-Cyclopentanecarboxylic Acid [2'-(1H-Tetrazol-5-Yl)-Biphenyl-4-Ylmethyl]-Amide)
CAS No.	748812-53-5
Molecular Formula	C30H32N6O2
Molecular Weight	508.62 g/mol
Synonyms	1-Pentanoylamino-cyclopentanecarboxylic acid [2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amide; Irbesartan Impurity A; Irbesartan Related Substance A; 1-[(2'-(1H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl]-N-(1-oxopentyl)-2-azaspiro[4.4]nonane-3-carboxamide; BMS 186295 Related Compound A; SR 47417 Impurity A
EINECS	Contact for details

Quality Control

Our Irbesartan Related Compound A is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality protocols are designed to support compliance with ICH Q3A/B, USP <476>, and EP guidelines for organic impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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