Description

Valsartan Impurity 61 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Valsartan, a widely prescribed antihypertensive drug. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing who require reliable reference compounds for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Valsartan API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Valsartan products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Valsartan during synthesis and formulation.

Basic Information

Product Name	Valsartan Impurity 61
CAS No.	2259707-96-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Related Compound 61; Valsartan EP Impurity G; Valsartan USP Impurity; (2'-(2H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl N-valeryl-N-{[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-L-valinate Impurity; Valsartan Degradant; Valsartan Process Impurity; L-Valine, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl ester
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 61 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability information are provided and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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