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Product Details:
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| Name: | Tenofovir Disoproxil Fumarate | Cas: | 202138-50-9 |
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| Mf: | C19H30N5O10P.C4H4O4 | Purity: | 99% |
| Appearance: | White Powder | Package: | 1kg/bag Or 25kgs/drum |
| High Light: | Tenofovir Disoproxil Fumarate,202138-50-9 Pharma Raw Materials,Treat Aids Tenofovir Disoproxil Fumarate |
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Tenofovir Disoproxil Fumarate CAS 202138-50-9 for Treat Aids Pharma Raw Materials
| Product name | Tenofovir Disoproxil Fumarate |
| Cas no | 202138-50-9 |
| Molecular Formular | C19H30N5O10P.C4H4O4 |
| Molecular weight | 635.51 |
| Appearance | WHITE |
| Purity | 99%+ |
| Brand | germax |
| Place of origin | China |
| MOQ | 1kg |
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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