| Articles |
Caractéristiques |
Résultats |
| Apparence |
A White to off white crystalline powder |
Poudre cristalline blanche |
| Solubilité |
Freely soluble in DMF and in methanol,sparingly soluble in water |
Se conformer |
| Identification |
UN). By IR: Positif |
Se conformer |
| B). By HPLC: Positif |
Se conformer |
| Résidus au feu |
0.2% maximum |
est conforme |
| Eau(By K.F) |
1.0% maximum |
0.4% |
| Métaux lourds |
20ppm max |
Se conformer |
Related Substance
(by HPLC) |
un (Tenofovir): 0.15% maximum |
Not detected |
| b (Adénine): 0.15% maximum |
Not detected |
| c (Tenofovir isoproxil monoester): 1.0% maximum |
0.29% |
| d (Tenofovir Disoproxil ethyl ester):0.15 maximum |
Not detected |
| e (Tenofovir isopropyl isoproxil ): 0.3% maximum |
Not detected |
| f (Tenofovir Disoproxil carbamate):0.15% maximum |
Not detected |
| g (Tenofovir Disoproxil Dimer):0.15% |
Not detected |
| Any Individual unspecified impuriy:0.1% |
0.09% |
| Impureté totale: 2.0% maximum |
0.40% |
| Enantiomeric Purity |
1.0% maximum |
Not detected |
| Tenofovir Disoproxil Related compound B |
5PPM max |
Not detected |
| Fumaric Acid |
17.5~19.0% |
18.03% |
| Solvants résiduels |
Éthanol: 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 |
| Essai (sur base anhydre) |
98.0% à 102.0% |
99.25% |
| Conclusion |
Comply with USP34 |