Description

Valsartan Impurity 5 CAS NO 1266616-11-8 is a specified impurity and degradation product of the antihypertensive active pharmaceutical ingredient (API) Valsartan. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control testing. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry who are involved in ensuring the purity, safety, and efficacy of Valsartan-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Valsartan API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating sensitive and specific chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the impurity profile.
• Process Chemistry Research: Aids in identifying and controlling the source of this impurity during the synthesis and purification of Valsartan.

Basic Information

Product Name	Valsartan Impurity 5
CAS No.	1266616-11-8
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Related Compound 5; Valsartan Impurity E; (S)-3-Methyl-2-(pentanoyl{[2'-(2H-1,2,3,4-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}amino)butanoic Acid; N-[(2'-Tetrazol-5-yl)biphenyl-4-ylmethyl]-N-valeryl-L-valine; L-Valine, N-[(2'-1H-tetrazol-5-yl)[1,1'-biphenyl]-4-ylmethyl]-N-pentanoyl-, (S)-; Valsartan Tetrazole Impurity; Valsartan Acid Impurity; Valsartan Degradant
EINECS	Contact for details

Quality Control

Every batch of Valsartan Impurity 5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity (IR, NMR), purity (HPLC), and related substances. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive). The container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.