Description

Irbesartan Impurity CAS NO 143618-44-4 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Irbesartan. This compound is critical for ensuring the safety and efficacy of antihypertensive medications by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on impurity characterization and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Irbesartan API and finished drug products.
• Analytical Method Development & Validation: Used as a known impurity to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: A key component in forced degradation and long-term stability studies to understand the degradation pathways of Irbesartan.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process of Irbesartan.

Basic Information

Product Name	Irbesartan Impurity
CAS No.	143618-44-4
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; 2-Butyl-3-([2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl)-1,3-diazaspiro[4.4]non-1-en-4-one; BMS 186295 Impurity; SR 47436 Impurity
EINECS	Contact for details

Quality Control

Every batch of Irbesartan Impurity (CAS 143618-44-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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