| 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: Positivo |
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| B). By HPLC: Positivo |
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| Residuo de ignición |
0.2% máximo |
cumple |
| Agua(By K.F) |
1.0% máximo |
0.4% |
| metales pesados |
20ppm máx. |
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Sustancia relacionada
(por HPLC) |
a (Tenofovir): 0.15% máximo |
Not detected |
| b (adenina): 0.15% máximo |
Not detected |
| do (Tenofovir isoproxil monoester): 1.0% máximo |
0.29% |
| d (Tenofovir Disoproxil ethyl ester):0.15 máximo |
Not detected |
| mi (Tenofovir isopropyl isoproxil ): 0.3% máximo |
Not detected |
| F (Tenofovir Disoproxil carbamate):0.15% máximo |
Not detected |
| gramo (Tenofovir Disoproxil Dimer):0.15% |
Not detected |
| Any Individual unspecified impuriy:0.1% |
0.09% |
| Total impurity: 2.0% máximo |
0.40% |
| Enantiomeric Purity |
1.0% máximo |
Not detected |
| Tenofovir Disoproxil Related compound B |
5PPM max |
Not detected |
| Fumaric Acid |
17.5~19.0% |
18.03% |
| Solventes residuales |
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 |
| Ensayo (en base anhidra) |
98.0% a 102.0% |
99.25% |
| Conclusión |
Comply with USP34 |