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 |
Résidu à l'allumage |
0.2% maximum |
complies |
Eau(By K.F) |
1.0% maximum |
0.4% |
Métaux lourds |
20ppm max |
Se conformer |
Related Substance
(par CLHP) |
un (Ténofovir): 0.15% maximum |
Non-détecté |
b (Adenine): 0.15% maximum |
Non-détecté |
c (Tenofovir isoproxil monoester): 1.0% maximum |
0.29% |
d (Tenofovir Disoproxil ethyl ester):0.15 maximum |
Non-détecté |
e (Tenofovir isopropyl isoproxil ): 0.3% maximum |
Non-détecté |
F (Tenofovir Disoproxil carbamate):0.15% maximum |
Non-détecté |
g (Tenofovir Disoproxil Dimer):0.15% |
Non-détecté |
Any Individual unspecified impuriy:0.1% |
0.09% |
Total impurity: 2.0% maximum |
0.40% |
Enantiomeric Purity |
1.0% maximum |
Non-détecté |
Tenofovir Disoproxil Related compound B |
5PPM max |
Non-détecté |
Fumaric Acid |
17.5~19.0% |
18.03% |
Residual solvents |
Éthanol: 5000ug/g max |
1159ug/g |
Isopropyl alcohol: 5000ug/g max |
1077ug/g |
Methylene chloride: 600ug/g max |
Non-détecté |
NMP: 530ug/g max |
Non-détecté |
Essai (on anhydrous basis) |
98.0% à 102.0% |
99.25% |
Conclusion |
Comply with USP34 |