Elementos |
Presupuesto |
Resultados |
Apariencia |
A White to off white crystalline powder |
polvo cristalino blanco |
Solubilidad |
Freely soluble in DMF and in methanol,sparingly soluble in water |
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Identificación |
A). By IR: Positive |
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B). By HPLC: Positive |
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Residuos en ignición |
0.2% máximo |
complies |
Agua(By K.F) |
1.0% máximo |
0.4% |
Heavy metals |
20ppm max |
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Related Substance
(por HPLC) |
un (Tenofovir): 0.15% máximo |
No detectado |
b (Adenine): 0.15% máximo |
No detectado |
C (Tenofovir isoproxil monoester): 1.0% máximo |
0.29% |
d (Tenofovir Disoproxil ethyl ester):0.15 máximo |
No detectado |
mi (Tenofovir isopropyl isoproxil ): 0.3% máximo |
No detectado |
F (Tenofovir Disoproxil carbamate):0.15% máximo |
No detectado |
gramo (Tenofovir Disoproxil Dimer):0.15% |
No detectado |
Any Individual unspecified impuriy:0.1% |
0.09% |
Total impurity: 2.0% máximo |
0.40% |
Enantiomeric Purity |
1.0% máximo |
No detectado |
Tenofovir Disoproxil Related compound B |
5PPM max |
No detectado |
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 |
No detectado |
NMP: 530ug/g max |
No detectado |
Ensayo (on anhydrous basis) |
98.0% a 102.0% |
99.25% |
Conclusión |
Comply with USP34 |