Items |
Spesifikasies |
Resultate |
Voorkoms |
A White to off white crystalline powder |
Wit kristallyne poeier |
Oplosbaarheid |
Freely soluble in DMF and in methanol,sparingly soluble in water |
Conform |
Identifikasie |
A). By IR: Positive |
Conform |
B). By HPLC: Positive |
Conform |
Residu by ontsteking |
0.2% maks |
complies |
Water(By K.F) |
1.0% maks |
0.4% |
Heavy metals |
20ppm max |
Conform |
Related Substance
(deur HPLC) |
a (Tenofovir): 0.15% maks |
Nie bespeur nie |
b (Adenine): 0.15% maks |
Nie bespeur nie |
c (Tenofovir isoproxil monoester): 1.0% maks |
0.29% |
d (Tenofovir Disoproxil ethyl ester):0.15 maks |
Nie bespeur nie |
e (Tenofovir isopropyl isoproxil ): 0.3% maks |
Nie bespeur nie |
f (Tenofovir Disoproxil carbamate):0.15% maks |
Nie bespeur nie |
g (Tenofovir Disoproxil Dimer):0.15% |
Nie bespeur nie |
Any Individual unspecified impuriy:0.1% |
0.09% |
Total impurity: 2.0% maks |
0.40% |
Enantiomeric Purity |
1.0% maks |
Nie bespeur nie |
Tenofovir Disoproxil Related compound B |
5PPM max |
Nie bespeur nie |
Fumaric Acid |
17.5~19.0% |
18.03% |
Residual solvents |
Etanol: 5000ug/g max |
1159ug/g |
Isopropyl alcohol: 5000ug/g max |
1077ug/g |
Methylene chloride: 600ug/g max |
Nie bespeur nie |
NMP: 530ug/g max |
Nie bespeur nie |
Toets (on anhydrous basis) |
98.0% aan 102.0% |
99.25% |
Afsluiting |
Comply with USP34 |