Description

Digoxin-16'-Glucuronide is a major, pharmacologically relevant metabolite of the cardiac glycoside digoxin. This compound is critical for research and development in the fields of pharmacology and clinical diagnostics, serving as a key reference standard. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of in-vitro diagnostic (IVD) kits for applications in drug metabolism studies, pharmacokinetic analysis, and bioanalytical method validation.

Application

• Pharmacokinetic and Metabolism Studies: Used as a certified reference standard to quantify and characterize the metabolic pathway of digoxin in biological samples.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring (TDM) of digoxin.
• Clinical Toxicology and Diagnostics: Serves as a calibrator or control in immunoassays and mass spectrometry-based IVD tests to ensure accurate measurement of digoxin and its metabolites in patient serum.
• Drug-Drug Interaction Research: Employed in studies investigating how other drugs affect the glucuronidation and clearance of digoxin.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., to FDA, EMA) regarding the metabolic profile of digoxin-based pharmaceuticals.
• Academic Research: Used in university and institutional labs for fundamental research on cardiac glycoside metabolism and transport mechanisms.

Basic Information

Product Name	Digoxin-16'-Glucuronide
CAS No.	68325-31-5
Molecular Formula	C₄₂H₆₆O₁₅
Molecular Weight	823.0 g/mol
Synonyms	Digoxin 16'-Glucuronide; Digoxin 16'-β-D-Glucuronide; 3β-[(O-2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide 16'-β-D-Glucopyranosiduronic Acid; Digoxin Glucuronide; Digoxin Monoglucuronide
EINECS	Contact for details

Quality Control

Our Digoxin-16'-Glucuronide is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (NMR, MS), to ensure it meets the high standards required for reference material applications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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