Description

Valsartan Impurity 3 CAS NO 443093-86-5 is a specified impurity of the active pharmaceutical ingredient (API) Valsartan, an angiotensin II receptor blocker used to treat hypertension and heart failure. This compound is critical for pharmaceutical manufacturers and analytical laboratories for quality control, method development, and regulatory compliance during drug substance and drug product development. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require high-purity reference standards to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Valsartan API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development (R&D): Facilitates studies on the degradation pathways and chemical behavior of Valsartan during synthesis and formulation.

Basic Information

Product Name	Valsartan Impurity 3
CAS No.	443093-86-5
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Related Compound C; Valsartan Impurity C; (S)-3-Methyl-2-(pentanoyl{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}amino)butanoic acid; N-[(2'-Cyano[1,1'-biphenyl]-4-yl)methyl]-L-valeryl-L-valine methyl ester impurity; L-Valine, N-[(2'-cyano[1,1'-biphenyl]-4-yl)methyl]-N-pentanoyl-, methyl ester; Valsartan Methyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 3 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided, which includes chromatographic data, retention times, and spectral information. The quality management adheres to cGMP principles, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent degradation.

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 ≤ 1.0% 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.