Description

Irbesartan Impurity CAS NO 1079997-01-5 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Irbesartan. This compound is critical for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control process-related impurities, ensuring final drug product safety and efficacy. It is an essential tool for research and development, method validation, and regulatory compliance within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material for the identification and quantification of impurities in Irbesartan API batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine testing in pharmaceutical QC laboratories to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Irbesartan to monitor impurity formation over time and under various stress conditions.
• Research on Drug Degradation Pathways: Used in academic and industrial research to elucidate the degradation mechanisms and metabolism of Irbesartan.

Basic Information

Product Name	Irbesartan Impurity
CAS No.	1079997-01-5
Molecular Formula	C27H30N6O3
Molecular Weight	486.57 g/mol
Synonyms	Irbesartan Related Compound; 2-Butyl-3-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one; Irbesartan Impurity F (EP); Irbesartan Spiro Impurity; Spiro Diketopiperazine Impurity of Irbesartan; BMS-186295 Impurity
EINECS	Contact for details

Quality Control

Every batch of Irbesartan Impurity (CAS 1079997-01-5) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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