Description

Valsartan Impurity 32 CAS NO 1353844-77-5 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Valsartan, a widely prescribed angiotensin II receptor blocker (ARB) for hypertension and heart failure. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) involved in method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific process-related impurities or degradation products in Valsartan Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate sensitive analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control and Batch Release Testing: Employed in routine QA/QC testing to monitor impurity levels against strict International Council for Harmonisation (ICH) guidelines, ensuring every batch of Valsartan API meets predefined specifications.
• Stability Studies and Forced Degradation: Acts as a marker in stability-indicating assays to track the formation of specific impurities over time under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies as per ICH Q3A(R2) and Q3B(R2) requirements.
• Research and Reference Standard: Used in academic and industrial research to study the chemical properties, synthesis pathways, and metabolic fate of Valsartan-related compounds.

Basic Information

Product Name	Valsartan Impurity 32
CAS No.	1353844-77-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Related Compound 32; Valsartan EP Impurity 32; Valsartan USP Impurity 32; (2'-(2H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl N-[(2S,3R)-2-([(2S)-2-[(pentanoyloxy)methyl]-3-phenylpropanoyl]amino)-3-methylbutanoyl]-L-valinate (proposed); Valsartan Tetrazole Ester Impurity; L-Valine, N-[(2S,3R)-2-[[(2S)-2-[(1-oxopentyl)oxy]methyl]-3-phenyl-1-oxopropyl]amino]-3-methyl-1-oxobutyl]-, (2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl ester
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and excipients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 desiccants or inert atmosphere conditions.

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)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.