| Testing Items |
Specification |
Result |
| Description : |
A white crystal |
conforms |
| Solubility: |
Sparingly soluble in chloroform |
comply very soluble in methanol and Ethanol,insoluble in water. |
| Identification: |
IR Similar to Standard |
comply |
| UV Similar to Standard Max at 251¡À1nm. |
comply |
| Reaction with chromic Thiocyanate: |
positive |
positive |
| Specific Rotation[-a]20: |
-67~-60 o |
-64.27 o (10mg per ml in Methanol, on anhydrous basis) |
| Loss On drying: |
¡Ü1.5% |
0.59% |
| Residue On Ignition: |
¡Ü0.1% |
0.07% |
| Heavy Metals: |
¡Ü20ppm |
Comply |
| Relative impurities(HPLC): |
Total impurities ¡Ü1.0% |
0.35% |
| individual impurity¡Ü0.5% |
0.09% |
| R-Isomer impurity: |
not more than 1.5% |
0.66% |
| Residual Solvents: |
Ethyl acetate not more than 0.5 % |
comply |
| n-Hexane not more than 0.1% |
comply |
| xylene(mixture) not more than0.217% |
comply |
| Assay (On Dry Basis): |
98.5~101.5% |
of valsartan |
| calculated on dried basis |
99.68% |
