Description

Irbesartan Impurity 15 Sodium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the antihypertensive drug Irbesartan, enabling accurate identification, quantification, and control during the manufacturing process. It is essential for analytical chemists and quality control laboratories in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Impurity Profiling & Control: Critical for monitoring and controlling the levels of this specific impurity in Irbesartan Active Pharmaceutical Ingredient (API) and finished drug products.
• Quality Assurance/Quality Control (QA/QC): Used in-house by API manufacturers and third-party testing labs to ensure batch-to-batch consistency and purity.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of this impurity over time under various storage conditions as part of drug stability testing protocols.
• Research & Development: Used in synthetic chemistry R&D to study degradation pathways and optimize purification processes for Irbesartan.

Basic Information

Product Name	Irbesartan Impurity 15 Sodium Salt
CAS No.	1145664-35-2
Molecular Formula	C27H27N6NaO3
Molecular Weight	506.54 g/mol
Synonyms	Irbesartan Related Compound 15 Sodium Salt; Sodium 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 EP Impurity C Sodium Salt; Irbesartan USP Impurity Sodium Salt; 1,3-Diazaspiro[4.4]non-1-ene-4-one, 2-butyl-3-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, sodium salt; Irbesartan Degradant Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Irbesartan Impurity 15 Sodium Salt is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	< 20 ppm

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