Description

Tenofovir Alafenamide Hemifumarate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is a key prodrug form of tenofovir, designed for enhanced cellular uptake and reduced systemic exposure compared to earlier analogs. It is essential for manufacturers in the global pharmaceutical industry developing next-generation antiviral therapies. The material is supplied under strict quality control to ensure consistency and reliability for critical drug formulation processes.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the synthesis of finished dosage forms for antiviral medications.
• Antiviral Drug Manufacturing: Critical intermediate in the production of medications for the treatment of HIV-1 and chronic Hepatitis B virus (HBV) infections.
• Pharmaceutical Research & Development: Serves as a reference standard and key building block in preclinical and clinical research for novel antiviral agents.
• Formulation Development: Used in the development of various drug delivery systems, including tablet and capsule formulations.
• Generic Drug Production: A vital component for manufacturers producing bioequivalent generic versions of patented antiviral drugs.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP-compliant drug product manufacturing.

Basic Information

Product Name	Tenofovir Alafenamide Hemifumarate
CAS No.	1392275-56-7
Molecular Formula	C21H29FN6O5 • ½ C4H4O4
Molecular Weight	534.53 g/mol (hemifumarate salt)
Synonyms	Tenofovir Alafenamide Fumarate (1:0.5); TAF Hemifumarate; GS-7340 Hemifumarate; (R)-PMPA Pr Isopropyloxycarbonyloxymethyl Ester Hemifumarate; (R)-9-(2-Phosphonylmethoxypropyl)adenine Isopropyloxycarbonyloxymethyl Ester Hemifumarate; Gilead Sciences Compound GS-7340 Salt; Vemlidy® API Intermediate
EINECS	Contact for details

Quality Control

Our Tenofovir Alafenamide Hemifumarate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols align with ICH guidelines and current Good Manufacturing Practices (cGMP). Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure compliance with your specific drug substance specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.2%
Heavy Metals	≤20 ppm

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