Description

Valsartan Impurity 1 CAS NO 914465-68-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Valsartan, a widely prescribed angiotensin II receptor blocker (ARB) for hypertension and heart failure. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling in compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specific impurities in Valsartan Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to meet ICH Q3A/B guidelines.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch testing in pharmaceutical manufacturing to ensure product purity and regulatory compliance.
• Stability Studies: Employed to monitor impurity formation in Valsartan formulations under various stress and storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in R&D laboratories to study the degradation pathways and metabolism of Valsartan.

Basic Information

Product Name	Valsartan Impurity 1
CAS No.	914465-68-2
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Related Compound 1; Valsartan Impurity A; (S)-3-Methyl-2-(pentanoyl{[2'-(2H-1,2,3,4-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}amino)butanoic Acid; N-Valeryl-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-L-valine; L-Valine, N-(1-oxopentyl)-N-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-; Valsartan N-Valeryl Impurity
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines, and specifications can be tailored to meet specific pharmacopeial or client requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere to ensure stability.

Specification

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

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