Description

Irbesartan Impurity 4 is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Irbesartan. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific process-related impurity. It is primarily used in research and development, method validation, and stability studies within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Irbesartan Impurity 4 in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Irbesartan API to ensure it meets stringent pharmacopeial (USP, EP) impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Irbesartan to minimize the formation of this specific impurity.

Basic Information

Product Name	Irbesartan Impurity 4
CAS No.	945540-26-1
Molecular Formula	C27H30N6O2
Molecular Weight	470.57 g/mol
Synonyms	Irbesartan Related Compound 4; 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; Spiro[imidazolidine-4,1'-cyclopentane] Impurity of Irbesartan; Irbesartan EP Impurity D; Irbesartan USP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Irbesartan Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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