| Items |
Specifications |
Proventus |
| Aspectus |
A White to off white crystalline powder |
Album pulveris crystallini |
| Solubilitas |
Freely soluble in DMF and in methanol,sparingly soluble in water |
Conformare |
| Lepidium sativum |
A). per IR: Positivum |
Conformare |
| B). per HPLC: Positivum |
Conformare |
| Requiesce in ignitio |
0.2% max |
obsequitur |
| Aquae(By K.F) |
1.0% max |
0.4% |
| Metalla gravis |
20ppm max |
Conformare |
Substantia cognata
(per HPLC *) |
a (Tenofovir): 0.15% max |
Non detectum |
| b (Adenine): 0.15% max |
Non detectum |
| c (Tenofovir isoproxil monoester): 1.0% max |
0.29% |
| d* (Tenofovir Disoproxil ethyl ester):0.15 max |
Non detectum |
| e (Tenofovir isopropyl isoproxil ): 0.3% max |
Non detectum |
| f* (Tenofovir Disoproxil carbamate):0.15% max |
Non detectum |
| g* (Tenofovir Disoproxil Dimer):0.15% |
Non detectum |
| Any Individual unspecified impuriy:0.1% |
0.09% |
| Totalis immunditiae: 2.0% max |
0.40% |
| Enantiomeric Purity |
1.0% max |
Non detectum |
| Tenofovir Disoproxil Related compound B |
5PPM max |
Non detectum |
| Fumaric Acid |
17.5~19.0% |
18.03% |
| RELICTUM menstrua |
Ethanol: 5000ug/g max |
1159ug/g |
| Isopropyl alcohol: 5000ug/g max |
1077ug/g |
| Methylene chloride: 600ug/g max |
Non detectum |
| NMP: 530ug/g max |
Non detectum |
| Assay (in anhydrous basis) |
98.0% to 102.0% |
99.25% |
| conclusio |
Comply with USP34 |
