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Active Pharmaceuticals

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  • Specifications
  • Product Description
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  • COA
Product Name Tenofovir Disoproxil Fumarate
CAS 202138-50-9
Appearance White Crystalline Powder
Molecular formula C23H34N5O14P
Molecular Weight 635.52
Assay 98%

Tenofovir Disoproxil Fumarate (a prodrug of tenofovir), belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), Tenofovir Disoproxil Fumarate block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate

Tenofovir disoproxil is an antiretroviral medication used to prevent and treat HIV/AIDS and to treat chronic hepatitis B. The active substance is tenofovir, while tenofovir disoproxil is a prodrug that is used because of its better absorption in the gut.

The drug is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. It is marketed by Gilead Sciences under the trade name Viread(as the fumarate, TDF). As of 2015 the cost for a typical month of medication in the United States is more than 200 USD.

Items Specifications Results
Appearance A White to off white crystalline powder White crystalline powder
Solubility Freely soluble in DMF and in methanol,sparingly soluble in water Conform
Identification A). By IR: Positive Conform
B). By HPLC: Positive Conform
Residue on ignition 0.2% max complies
Water(By K.F) 1.0% max 0.4%
Heavy metals 20ppm max Conform
Related Substance
(by HPLC)
a (Tenofovir): 0.15% max Not detected
b (Adenine): 0.15% max Not detected
c (Tenofovir isoproxil monoester): 1.0% max 0.29%
d (Tenofovir Disoproxil ethyl ester):0.15 max Not detected
e (Tenofovir isopropyl isoproxil ): 0.3% max Not detected
f (Tenofovir Disoproxil carbamate):0.15% max Not detected
g (Tenofovir Disoproxil Dimer):0.15% Not detected
Any Individual unspecified impuriy:0.1% 0.09%
Total impurity: 2.0% max 0.40%
Enantiomeric Purity 1.0% max Not detected
Tenofovir Disoproxil Related compound B 5PPM max Not detected
Fumaric Acid 17.5~19.0% 18.03%
Residual solvents Ethanol: 5000ug/g max 1159ug/g
Isopropyl alcohol: 5000ug/g max 1077ug/g
Methylene chloride: 600ug/g max Not detected
NMP: 530ug/g max Not detected
Assay (on anhydrous basis) 98.0% to 102.0% 99.25%
Conclusion Comply with USP34

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