Description

Valsartan Impurity 10 CAS NO 1314799-74-0 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Valsartan. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Valsartan Impurity 10 in drug substances and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Valsartan API.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development (R&D): Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Valsartan Impurity 10
CAS No.	1314799-74-0
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan N-2 Impurity; Valsartan Related Compound 10; (S)-3-Methyl-2-(pentanoyl{[2'-(2H-1,2,3,4-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}amino)butanoic acid; Valsartan Tetrazole Impurity; L-Valine, N-[(2'-[(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]pentanoyl]-; BMS-NDI; Valsartan Process Impurity; BPHA Impurity of Valsartan
EINECS	Contact for details

Quality Control

Our Valsartan Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed test results are provided for traceability and compliance.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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