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Product Details:
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Name: | Tenofovir Disoproxil Fumarate | Cas: | 202138-50-9 |
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Appearance: | White Powder | Purity: | 99% |
Package: | 1kg/carton; 25kg/drum | Standard: | USP/EP/CP/BP |
Storage: | Keep In Dark And Dry Place | MF: | C23H34N5O14P |
High Light: | 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
1. Description
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.[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.
3. Tenofovir Disoproxil Fumarate(TDF)
Food Interactions: None
Very well tolerated, side effects are minimal.
Toxicity:
Renal insufficiency(rare)
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 | |
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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