Description

Valsartan Desvaleryl Impurity is a key pharmaceutical reference standard used in the quality control and analytical development of Valsartan, a widely prescribed angiotensin II receptor blocker (ARB). This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of desvaleryl impurity in Valsartan active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to meet ICH Q2(R1) requirements.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Utilized in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Valsartan Desvaleryl Impurity
CAS No.	676129-92-3
Molecular Formula	C23H28N6O3
Molecular Weight	436.51 g/mol
Synonyms	Desvaleryl Valsartan; Valsartan Impurity D (EP); Valsartan Related Compound D (USP); (S)-3-Methyl-2-(pentanoylamino)butanoic acid [2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl ester; N-Valeryl-L-valine benzyl ester derivative of Valsartan; L-Valine, N-(1-oxopentyl)-, (2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl ester; Valsartan N1 Impurity.
EINECS	Contact for details

Quality Control

Our Valsartan Desvaleryl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A, USP, and European Pharmacopoeia standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectroscopic data, is provided with every shipment to guarantee traceability and reliability for your critical applications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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