Description

Rac-Valsartan Ep Impurity B is a critical reference standard used in the pharmaceutical development and quality control of Valsartan, a widely prescribed angiotensin II receptor antagonist. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during active pharmaceutical ingredient (API) manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Rac-Valsartan Ep Impurity B in Valsartan API batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Essential for routine quality control testing to ensure Valsartan API meets stringent pharmacopeial specifications (e.g., EP, USP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry R&D to understand and minimize the formation of this impurity during the Valsartan synthesis pathway.

Basic Information

Item	Details
Product Name	Rac-Valsartan Ep Impurity B
CAS No.	1894176-44-3
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan EP Impurity B (Racemic); (2R/S)-2-[(2'-(2H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl]-3-methylbutanoic acid impurity; Valsartan Diastereomer Impurity; Valsartan Related Compound B; N-Valeryl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine Impurity B; (R,S)-Valsartan Impurity B; BPAB Tetrazole Derivative Impurity.
EINECS	Contact for details

Quality Control

Every batch of Rac-Valsartan Ep Impurity B CAS 1894176-44-3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere 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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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