Description

[2H6]-Tenofovir Alafenamide Fumarate is a deuterium-labeled analog of the key antiviral prodrug Tenofovir Alafenamide, serving as a critical internal standard for precise bioanalytical quantification. This stable isotope-labeled compound is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies in drug development. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and quality control of antiviral therapies.

Application

• Bioanalytical Internal Standard: Used in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Tenofovir Alafenamide and its metabolites in biological matrices (plasma, serum, tissue).
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Pharmaceutical Quality Control: Acts as a reference standard in impurity profiling and assay development for drug substance and finished product testing.
• Stable Isotope Dilution Assays: Provides high accuracy in quantitative analysis by correcting for matrix effects and instrument variability.
• Regulatory Submissions: Supports data packages for regulatory authorities (e.g., FDA, EMA) by providing validated analytical methods with internal standards.

Basic Information

Product Name	[2H6]-Tenofovir Alafenamide Fumarate
CAS No.	390409-17-3
Molecular Formula	C23H28D6N6O5P • C4H4O4
Molecular Weight	636.62 g/mol (for fumarate salt)
Synonyms	Tenofovir Alafenamide-d6 Fumarate; GS-7340-d6 Fumarate; (R)-PMPA-d6 ProDop Fumarate; (R)-9-[2-[[[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]-methoxy]propyl]adenine-d6 Fumarate; Deuterated Tenofovir Alafenamide Fumarate; TAF-d6 Fumarate; Gilead GS-7340-d6 Fumarate; (2R)-2-[[(S)-[[(1R)-2-(6-Amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxy-phosphinyl]amino]propanoic acid 1-methylethyl ester-d6 Fumarate
EINECS	Contact for details

Quality Control

Our deuterated reference standards are manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity. Each batch is characterized by advanced analytical techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (≥98 atom % D), chemical purity (by HPLC), and confirming identity and structure. We support compliance with GMP/GLP guidelines for use in regulated studies.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Atom % D)	≥98.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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