Description

Valsartan Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Valsartan, an angiotensin II receptor blocker. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and regulatory compliance testing. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Valsartan API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure analytical procedures are performing as intended.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Valsartan products.
• Research & Development: Used in pharmaceutical R&D to study impurity profiles, degradation pathways, and to synthesize purer batches of the API.

Basic Information

Product Name	Valsartan Impurity 12
CAS No.	1189547-11-2
Molecular Formula	C24H29N5O3
Molecular Weight	435.52 g/mol
Synonyms	Valsartan Related Compound 12; (S)-3-Methyl-2-(pentanoyl{[2'-(2H-1,2,3,4-tetrazol-5-yl)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-; Valsartan Impurity K; Valsartan EP Impurity K; Valsartan USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Valsartan Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity by HPLC, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.