Tenofovir Disoproxil Fumarate molecular structure

Tenofovir Disoproxil Fumarate

Also known as: Viread, Tenvir, Tavin, Tenof (component of Truvada, Atripla, Trustiva)

CAS Number: 202138-50-9

Nucleotide Reverse Transcriptase Inhibitor (NtRTI)

Pharmacopeia Standards

USPIPEPBPWHO

Mechanism of Action

Tenofovir disoproxil fumarate is an orally bioavailable prodrug that is hydrolysed by plasma and tissue esterases to tenofovir, an acyclic nucleoside phosphonate analogue of adenosine monophosphate. Cellular kinases then phosphorylate tenofovir to its active diphosphate, which competes with deoxyadenosine 5-triphosphate for incorporation by HIV-1 reverse transcriptase and hepatitis B DNA polymerase. Because the molecule lacks a 3-hydroxyl group, incorporation terminates the growing viral DNA chain.

Technical Specifications

Generic / INN NameTenofovir Disoproxil Fumarate
CAS Registry Number202138-50-9
Molecular FormulaC23H34N5O14P
Molecular Weight635.51 g/mol g/mol
Typical PurityNot less than 98.0% on anhydrous basis (USP/IP); single impurity NMT 0.15%
Storage ConditionsStore in tightly closed HDPE-lined containers below 25 degrees C, protected from light and moisture; desiccant recommended.
Shelf Life36 months from date of manufacture in original sealed packing
CategoryAntiretrovirals (HIV)

Specifications are indicative and intended for sourcing reference only. Always confirm against the supplier's Certificate of Analysis and the applicable pharmacopeial monograph before issuing a purchase specification.

Typical Applications

Bulk API for first-line fixed-dose combination antiretroviral tablets (with lamivudine or emtricitabine plus dolutegravir or efavirenz), single-entity 300 mg tablets, chronic hepatitis B therapy, and HIV pre-exposure prophylaxis formulations supplied into donor-funded programmes.

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