Description

n-Desethyl Vardenafil-D8 is a high-purity, deuterium-labeled internal standard critical for modern analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative analysis in complex biological matrices. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for method development and validation in pharmacokinetic and bioequivalence studies.

Application

• LC-MS/MS Internal Standard: Primary application as a stable, isotopically labeled reference standard for the precise quantification of Vardenafil and its metabolites in biological samples (e.g., plasma, serum).
• Pharmaceutical Research & Development: Used in drug metabolism and pharmacokinetics (DMPK) studies to track the absorption, distribution, metabolism, and excretion (ADME) profile of active pharmaceutical ingredients.
• Bioanalytical Method Validation: Critical for developing and validating robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables accurate measurement of drug concentrations in patient samples during clinical trials to establish safety and efficacy.
• Forensic and Anti-Doping Analysis: Supports the detection and confirmation of pharmaceutical substances in forensic toxicology and sports doping control.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability testing of pharmaceutical formulations containing related compounds.

Basic Information

Product Name	n-Desethyl Vardenafil-D8
CAS No.	1184985-26-9
Molecular Formula	C21H26D8N6O4S
Molecular Weight	~ 490.62 g/mol
Synonyms	Vardenafil Desethyl D8; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one-d8; Desethyl Vardenafil D8; Vardenafil Metabolite D8; Vardenafil-d8 Desethyl Analog; (Desethyl) Vardenafil Deuterated Standard; LEVITRA Metabolite D8 Internal Standard
EINECS	Contact for details

Quality Control

Every batch of n-Desethyl Vardenafil-D8 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity verified by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity (HPLC assay), isotopic enrichment, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
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.