Description

Tenofovir Disoproxil Fumarate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) of critical importance in antiviral therapy. Its primary value lies in its role as a prodrug of tenofovir, enabling effective intracellular delivery for potent antiviral activity. This compound is essential for manufacturers in the global pharmaceutical industry developing and producing antiviral medications, particularly for the treatment of HIV-1 and chronic Hepatitis B.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of antiviral tablets and capsules.
• Key intermediate in the synthesis of complex antiviral drug formulations under Good Manufacturing Practice (GMP) conditions.
• Critical component in research and development for new antiviral therapies and combination drugs.
• Reference standard for quality control and analytical testing in pharmaceutical laboratories.
• Used in the production of generic antiviral medications for global healthcare programs.
• Raw material for preclinical and clinical trial material (CTM) manufacturing.

Basic Information

Product Name	Tenofovir Disoproxil Fumarate
CAS No.	202138-50-9
Molecular Formula	C23H34N5O14P • C4H4O4
Molecular Weight	635.51 g/mol
Synonyms	Tenofovir DF; TDF; Bis(POC)PMPA; (R)-[[2-(6-Amino-9H-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid bis(isopropoxycarbonyloxymethyl) ester fumarate; 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate; Viread (brand name active ingredient); PMPA bis(POC) ester fumarate
EINECS	Contact for details

Quality Control

Our Tenofovir Disoproxil Fumarate is manufactured and tested to meet exacting pharmaceutical standards. Quality is assured through a comprehensive battery of analytical tests including HPLC for purity, residual solvent analysis, and stringent control of related substances. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) confirming compliance with relevant specifications, including potential USP/EP monograph requirements, are available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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