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|Name:||Tenofovir Disoproxil Fumarate||Cas:||202138-50-9|
|Storage:||Keep In Dark And Dry Place||MF:||C23H34N5O14P|
Tenofovir Disoproxil Fumarate,
202138-50-9 Pharma Raw Materials,
C23H34N5O14P Pharma Raw Materials
Tenofovir Disoproxil Fumarate CAS 202138-50-9 for Treat Aids Pharma Raw Materials
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.
2. 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. 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.
3. Tenofovir Disoproxil Fumarate(TDF)
Food Interactions: None
Very well tolerated, side effects are minimal.
Must dose adjust with renal failure.
Also has activity against Hepatitis B.
Dosed 300mg QD.
Active against Lamivudine resistant HBV strains.
HBV resistance 1% at one year.
If TDF is stopped, may have HBV hepatitis flare.
Specification Sheet (COA)
|Product name||Tenofovir Disoproxil Fumarate||CAS no.||202138-50-9|
|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|
|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|
|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%|
Comply with USP34
Contact Person: July