Description

Valsartan Impurity 3 Sodium Salt is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the identification, quantification, and control of a specific impurity during the manufacturing and quality assurance of Valsartan, an important angiotensin II receptor blocker (ARB) medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of Valsartan Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure they remain within specified limits.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data as required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and behavior of this specific impurity under various stress conditions and throughout the drug product's shelf life.
• Research and Development (R&D): Used in pharmaceutical R&D to study impurity formation pathways, degradation chemistry, and to develop robust purification processes.

Basic Information

Product Name	Valsartan Impurity 3 Sodium Salt
CAS No.	920034-07-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Related Compound C Sodium Salt; Valsartan Impurity C Sodium Salt; (S)-3-Methyl-2-(pentanoyl{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}amino)butanoic Acid Sodium Salt; Valsartan EP Impurity C Sodium Salt; Valsartan USP Impurity C Sodium Salt; N-Valeryl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine Sodium Salt
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 3 Sodium Salt is manufactured under strict quality systems to ensure the highest standards of purity and consistency required for pharmaceutical analysis. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and impurity profile. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your regulatory and quality requirements.

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 product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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