Description

Valsartan Impurity 37 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antihypertensive drug Valsartan. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Valsartan Impurity 37 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug product specifications are met.
• Stability Studies: Employed to track the formation of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for Valsartan.

Basic Information

Product Name	Valsartan Impurity 37
CAS No.	1071286-94-6
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Related Compound 37; (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)[1,1'-biphenyl]-4-yl]methyl]-L-valine; L-Valine, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (S)-; Valsartan N-Valeryl Impurity; Valsartan Process Impurity
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 37 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality commitment aligns with cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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