| Ibandronic Acid | |
| Specification | For : Ibandronic Acid |
| Test | Specification |
| Description | White flowing powder |
| Solubility | Soluble in water, slight soluble in methanol |
| Clarity of Solution | Colourless, Clarify |
| Heavy Metals | Limit : Max. 20PPM |
| Phosphite | Limit : Max. 0.3% |
| Phosphate | Limit : Max. 0.3% |
| Relative Substance | Any single impurity : Max. 0.3% Total Impurity : Max. 1% |
| Assay | Limit : 98% to 102% |
| 3-(N-methylpenthylamino)propionic acid HCL | |
| Specification | For : 3-(N-methylpenthylamino)propionic acid HCL |
| CAS NO | 625120-81-2 |
| Chemical Composition | C9H19NO2HCl |
| Test | Specification |
| Description | White Crystalline or crystalline Powder |
| Melting Point | Limit : 98° - 100° C |
| Relative Substance | Total Impurity : Max. 0.5% Any single impurity : Max. 0.2% |
| Residue on ignition | Limit : Max.0.2% |
| Loss on Drying | Limit : Max.0.2% |
| Assay | Limit: Min.99% |
