| Function: | Antiviral |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Items | Standard |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in dimethylformamide;Slightly soluble in water |
| Identification | The IR spectrum of test sample is concordant with that of the Tenofovir Disoproxil Fumarate USP Reference Standard obtained in the similar manner. |
| The retention time of the major peak in the chromatogram of the test solution corresponds to that in the chromatogram of the standard solution, as obtained in the test of Enantiomeric Purity. | |
| Water | Not more than 1.0% |
| Heavy Metals | Not more than 20ppm |
| Residue On Ignition | Not more than 0.2% |
| Enantiomeric Purity (Tenofovir disoproxil related compound A) |
Not more than 1.0% |
| Residual Solvents | Ethyl acetate is not more than 0.2% |
| Dichloromethane is not more than 0.06% | |
| N-Methylpyrrolidinone is not more than 0.053% | |
| N,N-Dimethylformamide is not more than 0.088% | |
| Isopropanol is not more than 0.3% | |
| cyclohexane is not more than 0.10% | |
| Tert-butyl alcohol is not more than 0.01% | |
| Triethylamine(TEA) is not more than 0.032% | |
| Total residual solvents not more than 0.6% | |
| Chromatographic Purity | Tenofovir(impurity with relative retention time at about 0.14) is not more than 0.15% |
| Adenine(impurity with relative retention time at about 0.16) is not more than 0.15% | |
| Tenofovir isoproxil monoester(impurity with relative retention time at about 0.24) is not more than 1.0% | |
| Tenofovir disoproxil ethyl ester (impurity with relative retention time at about 0.80) is not more than 0.15% | |
| Tenofovir isopropyl isoproxil(impurity with relative retention time at about 0.82) is not more than 0.30% | |
| Tenofovir disoproxil carbamate(impurity with relative retention time at about 1.40) is not more than 0.15% | |
| Tenofovir disoproxil dimer (impurity with relative retention time at about 1.76) is not more than 0.15% | |
| Any Individual unspecified impurity is not more than 0.10% | |
| Total impurities is not more than 2.0% | |
| Chloromethyl isopropyl Carbonate |
Not more than 0.15% |
| Fumaric acid | 17.5%~19.0%(on anhydrous basis) |
| Assay | 98.0%~102.0%(on the anhydrous basis) |
| (E)-9-(Prop-1-enyl)-9H-purin-6-amine(Contract test) | not more than 0.0005% |
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