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Tenofovir Disoproxil Fumarate Raw Drug For HIV Infection Treatment

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Buy Tenofovir Disoproxil Fumarate Raw Drug For HIV Infection Treatment CAS 202138-50-9

 

Tenofovir disoproxil fumarate Sepcification

Product Name: Tenofovir disoproxil fumarate
CAS:202138-50-9
Standard: Corporate Standard
Level: Pharmaceutical grade
Content: 99%
Appearance: white powder
Packing: 25KG/cardboard drum
Ingredients: 9-((R)-2-((bis(((isopropoxycarbonyl)oxy(methoxy)phosphinyl)-propyl)adenine fumarate
Physicochemical properties: white or almost white crystalline powder; odorless. Soluble in dimethylformamide, soluble in methanol; slightly soluble in water, acetonitrile
Category: Pharmaceutical Raw Materials
Field: Antiviral drugs
Deferred product: Tenofovir disoproxil fumarate tablets
Application: For the treatment of human immunodeficiency virus (HIV) infection

 

What is tenofovir disoproxil fumarate?

Tenofovir DF is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older. Tenofovir DF is always used in combination with other HIV medicines.

Tenofovir DF belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

 

Tenofovir disoproxil fumarate Certificate Of Analysis

Product name Tenofovir disoproxil fumarate
CAS No. 202138-50-9 Outer Packing 25KG
Production date 2017.04.20 Shelf life 2019.04.19
Standard adopted ENTERPRISE STANDARD
Items of analysis Specification Results
Appearance White to off-white crystalline powder white crystalline powder
Solubility Freely soluble in the methanol and in dimethyl form anmmide;sparingly soluble in water conforms
Identifcation By IR /HPLC conforms
Water(ByK.F) NMT 1.0% 0.44%
Fumaric acid 17.5-19% 18.30%
Heavy metal ≤0.002% conforms
Tenofovir ≤0.15% 0.08%
Tenofovir isoproxil monoester ≤0.8% 0.28%
Tenofovir isopropyl isoproxil ≤0.15% conforms
Desmethyl isopriopyl disproxil ≤0.15% conforms
Specified unidentified impurity at RRT1.05(molecular weight 541) ≤0.15% conforms
Any individual unspecified impurity ≤0.1% 0.05%
Total impurites ≤1.0% 0.38%
Chloromethy isopropyl carbonate By GC ≤0.15% conforms
Enantiomeric purity By HPLC ≤1.0% conforms
9-Propenyladenine By HPLC 5ppm ND
Isopropyl alcohol ≤3000ppm conforms
Dichloromethane ≤300ppm conforms
Isopropyl acetate ≤4000ppm conforms
N-methyl pyrrolidone ≤480ppm conforms
Total residual solvents ≤7780ppm conforms
Assay(on the anhydrous) 98-102% 99.62%
Conclusion Qualified

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