Items |
Specifikacije |
Rezultati |
Videz |
A White to off white crystalline powder |
Bel kristalinični prah |
Topnost |
Freely soluble in DMF and in methanol,sparingly soluble in water |
Conform |
Identifikacija |
A). Z IR: Positive |
Conform |
B). By HPLC: Positive |
Conform |
Ostanek pri žarenju |
0.2% maks |
complies |
voda(By K.F) |
1.0% maks |
0.4% |
Težke kovine |
20ppm max |
Conform |
Related Substance
(s HPLC) |
a (Tenofovir): 0.15% maks |
Not detected |
b (Adenine): 0.15% maks |
Not detected |
c (Tenofovir isoproxil monoester): 1.0% maks |
0.29% |
d (Tenofovir Disoproxil ethyl ester):0.15 maks |
Not detected |
e (Tenofovir isopropyl isoproxil ): 0.3% maks |
Not detected |
f (Tenofovir Disoproxil carbamate):0.15% maks |
Not detected |
g (Tenofovir Disoproxil Dimer):0.15% |
Not detected |
Any Individual unspecified impuriy:0.1% |
0.09% |
Total impurity: 2.0% maks |
0.40% |
Enantiomeric Purity |
1.0% maks |
Not detected |
Tenofovir Disoproxil Related compound B |
5PPM max |
Not detected |
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 |
Not detected |
NMP: 530ug/g max |
Not detected |
Esej (on anhydrous basis) |
98.0% do 102.0% |
99.25% |
Zaključek |
Comply with USP34 |