Description

Valsartan Related Compound A is a high-purity chemical reference standard, identified by CAS No. 137862-87-4, which is critical for ensuring the quality and safety of pharmaceutical products. This compound serves as a key impurity marker in the analysis and validation of Valsartan, an important angiotensin II receptor blocker (ARB) used to treat hypertension and heart failure. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as an impurity standard for the identification and quantification of related substances in Valsartan Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities and degradation products.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Valsartan products meet the purity specifications outlined in pharmacopeias (USP, EP, JP).
• Stability Studies: Employed to track the formation of specific impurities over time under various stress conditions (e.g., heat, light, humidity) for drug substance and product stability profiling.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Utilized in synthetic chemistry research to understand and control impurity formation pathways during the manufacturing process of Valsartan.

Basic Information

Product Name	Valsartan Related Compound A
CAS No.	137862-87-4
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Impurity A; Valsartan EP Impurity A; Valsartan USP Related Compound A; (S)-3-Methyl-2-(pentanoyl{[2'-(2H-1,2,3,4-tetrazol-5-yl)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
EINECS	Contact for details

Quality Control

Our Valsartan Related Compound A is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identification (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with major pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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