Description

Digoxin-D3 is a stable isotope-labeled analog of the cardiac glycoside digoxin, specifically deuterated at three positions. This high-purity reference standard is essential for ensuring analytical accuracy and traceability in quantitative bioanalysis. It is primarily utilized by pharmaceutical research laboratories, contract research organizations (CROs), and diagnostic manufacturers for applications requiring precise internal standardization. The compound, identified by CAS No. 127299-95-0, is critical for method development and validation in pharmacokinetic and therapeutic drug monitoring studies.

Application

• Internal Standard for LC-MS/MS: Serves as a critical deuterated internal standard for the accurate quantification of digoxin in biological matrices (e.g., plasma, serum) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic & Bioequivalence Studies: Enables precise measurement of digoxin concentration-time profiles in clinical trials to assess drug absorption, distribution, and elimination.
• Therapeutic Drug Monitoring (TDM): Used in the development and routine application of assays to monitor digoxin levels in patient blood, ensuring efficacy and avoiding toxicity.
• Metabolite Identification & Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based metabolism studies.
• Method Development & Validation: Provides a stable, non-interfering reference point for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Manufacturing: Supports in-process testing and final product release testing for digoxin-containing pharmaceutical formulations.
• Forensic & Clinical Toxicology: Assists in the confirmatory analysis of digoxin in cases of suspected overdose or poisoning.

Basic Information

Product Name	Digoxin-D3
CAS No.	127299-95-0
Molecular Formula	C₄₁H₆₁D₃O₁₄
Molecular Weight	784.98 g/mol (for C₄₁H₆₁D₃O₁₄)
Synonyms	Digoxin-d3; 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-d3; 12β-Hydroxydigitoxin-d3; Lanoxin-d3 (labeled analog); Deuterated Digoxin; Digoxin (phenyl-d3)
EINECS	Contact for details

Quality Control

Our Digoxin-D3 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, chemical and isotopic purity, and residual solvents. We support compliance with ICH Q2(R1) guidelines for analytical method validation and can provide materials suitable for use in regulated environments (GLP/GMP). Certificates of Analysis 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 or CoA. This product is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Purity (MS)	≥ 99.0 atom % D (D3 label)
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.