Description

Valsartan Impurity 36 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Valsartan, a widely prescribed antihypertensive drug. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Valsartan Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity structure and aiding in the establishment of acceptable limits.
• Stability Studies: Employed to track the formation of degradation products in Valsartan formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways and metabolism of Valsartan.

Basic Information

Item	Details
Product Name	Valsartan Impurity 36
CAS No.	1418314-03-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Related Compound 36; Valsartan Impurity 36 (EP); Valsartan Impurity 36 (USP); Valsartan EP Impurity G; (2'-(2H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl (2S)-3-methyl-2-[(pentanoyl{4-[2-(2H-tetrazol-5-yl)phenyl]phenyl}amino)butanoate; N-Pentanoyl-N-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine, 1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] Ester
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 36 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation (IR, 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.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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 unspecified 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.