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White Solid Tenofovir Disoproxil Fumarate Pharmaceutical Active Ingredients

  • White Solid Tenofovir Disoproxil Fumarate Pharmaceutical Active Ingredients
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Product Description

White Solid Tenofovir Disoproxil Fumarate Pharmaceutical Active Ingredients 202138-50-9


Tenofovir disoproxil fumarate Raw Material


Synonyms: Tenofovir disoproxil fumarate;TENOFOVIR DISOPROXIC;9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate;2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, bis(2,2-dimethylpropyl) ester, 5-oxide, (R)-;Aids031697;Aids-031697;Bis(neopentyloc)pmpa;Tenofovir diisoproxil fuMarate
CAS: 202138-50-9
MF: C23H34N5O14P
MW: 635.51
Product Categories: Tenofovir;Bases & Related Reagents;Intermediates & Fine Chemicals;Nucleotides;Pharmaceuticals;Phosphorylating and Phosphitylating Agents;Inhibitors
Melting point : 113-115°C
Storage temp. : Refrigerator
Chemical Properties White Solid
Usage tyrosinase inhibitor used for skin lightening and anti-melasma
Usage An acyclic phosphonate nucleotide analog and selective HIV-1 RT inhibitor
Usage Acyclic phosphonate nucleotide analogue; reverse transcriptase inhibitor. Used as an anti-HIV agent. Antiviral.

Tenofovir disoproxil fumarate Descriptions

Tenofovir is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Tenofovir disoproxil fumarate Pharmacokinetics

Tenofovir is hardly absorbed through the gastrointestinal tract, for this reason, prodrug of Tenofovir has been developed by esterification, and then to make tenofovir fumarate ester. Tenofovir ester is water-soluble, can be rapidly absorbed and degraded into the active tenofovir, and then was metabolized to the active Tenofovir disoproxil .

Tenofovir will reach the peak of plasma Concentration within 1-2 h after administration. When combined with food service, the bioavailability of Tenofovir can be increased by 40%. Intracellular half-life of Tenofovir disoproxil is about 10 h, it needs dosing everyday. Because Tenofovir is not a CYP-450 substrate, this may decrease the possibility of interactions with other drug caused by CYP450. Elimination of Tenofovir is by glomerular filtration and active tubular secretion. Approximately 70% to 80% is recovered in urine as unchanged drug. Elimination half-life is approximately 17 h .

Indications: Tenofovir is indicated for the treatment of HIV, HBV infection. This product also can cooperated with other reverse transcriptase inhibitors for HIV-1 infection and hepatitis B treatment .


Medical Applciation

HIV-1 infection: Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.[5] This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of tenofovir in treatment-naive and treatment-experienced adults.

Tenofovir is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.


Product name Tenofovir Disoproxil Fumarate CAS no. 202138-50-9
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

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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