Description

Valsartan D9 is a deuterium-labeled isotopologue of the widely prescribed antihypertensive drug, Valsartan, specifically designed for use as an internal standard in quantitative bioanalytical methods. Its primary value lies in providing unmatched accuracy and reliability in pharmacokinetic studies, drug metabolism research, and therapeutic drug monitoring by correcting for variations during sample preparation and analysis. This high-purity reference material is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies conducting advanced LC-MS/MS analyses to ensure precise quantification of Valsartan in biological matrices.

Application

• Internal Standard for LC-MS/MS: Critical for the accurate quantification of Valsartan in plasma, serum, and urine samples during bioanalytical method development and validation.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical trials.
• Drug Metabolism and Metabolite Identification: Used as a stable isotope-labeled tracer to study metabolic pathways and identify novel metabolites.
• Therapeutic Drug Monitoring (TDM): Supports the development of robust clinical assays to optimize Valsartan dosing for individual patients.
• Forensic and Doping Control Analysis: Provides a reliable reference for confirming the presence and concentration of Valsartan in forensic toxicology and anti-doping tests.
• Quality Control in Pharmaceutical Manufacturing: Serves as a critical standard for in-process testing and final product release assays in API production.

Basic Information

Product Name	Valsartan D9
CAS No.	1089736-73-1
Molecular Formula	C24H20D9N5O3
Molecular Weight	Approx. 443.56 g/mol
Synonyms	(S)-N-(1-Oxopentyl)-N-[[2'-(2H-1,2,3,4-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine-d9; L-Valine, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (S)-, d9-; Deuterated Valsartan; Valsartan-d9; Valsartan (deuterated); Valsartan Internal Standard; CGP 48933-d9; NSC 710663-d9
EINECS	Contact for details

Quality Control

Our Valsartan D9 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing chemical purity, isotopic purity (D-enrichment), and analytical results from techniques including HPLC, NMR, and MS. We support compliance with ICH Q7, GMP, and ISO 9001 standards for pharmaceutical reference materials. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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