Description

Valsartan Impurity 26 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities during the manufacture of the antihypertensive drug Valsartan. It is an essential tool 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: Identification and quantification of this specific impurity in Valsartan Active Pharmaceutical Ingredient (API) batches.
• Quality Control (QC) Testing: Used in-house by API manufacturers and third-party testing labs to monitor and control impurity levels against ICH guidelines.
• Regulatory Submissions: Supporting documentation for drug master files (DMFs), ANDAs, and other regulatory filings to demonstrate comprehensive impurity understanding.
• Stability Studies: Monitoring the formation of this impurity in Valsartan drug products under various stress and storage conditions.
• Research & Development: Investigating the formation pathway, chemical properties, and toxicological significance of this impurity.

Basic Information

Product Name	Valsartan Impurity 26
CAS No.	2254485-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Related Compound 26; Valsartan EP Impurity 26; Valsartan USP Impurity 26; Valsartan Process Impurity 26; (2'-(2H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl N-[(2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl]-L-valinate (discrete structure to be confirmed); Valsartan Dimer Impurity; Valsartan Bis-Tetrazole Impurity
EINECS	Contact for details

Quality Control

Every batch of Valsartan Impurity 26 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 MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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