Description

Irbesartan Impurity 14 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Irbesartan through rigorous impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance testing. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Identification in the manufacturing of Irbesartan API.
• Analytical Method Development and Validation for HPLC, UPLC, and other chromatographic techniques.
• Quality Control and Release Testing of Irbesartan drug substances and finished dosage forms.
• Stability Studies to monitor the formation of degradation products under various stress conditions.
• Regulatory Submissions and Compliance, supporting filings with agencies like the FDA, EMA, and PMDA.
• Research and Development into the metabolism and degradation pathways of Irbesartan.
• Calibration Standard for quantitative analysis in quality assurance laboratories.
• Reference Material for pharmacopeial testing and cross-laboratory comparisons.

Basic Information

Product Name	Irbesartan Impurity 14
CAS No.	133690-91-2
Molecular Formula	C27H30N6O3
Molecular Weight	486.57 g/mol
Synonyms	Irbesartan Related Compound; 2-Butyl-3-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one; Spiro[imidazolidine-4,9'-fluorene] impurity; AVAPRO Impurity; SR 47417 Impurity; BMS-186295 Impurity
EINECS	Contact for details

Quality Control

Every batch of Irbesartan Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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