| Etidronate Disodium USP | |
| Specification | For : Etidronate Disodium USP |
| Test | Specification |
| Description | White crystalline powder |
| Identification A) By I.R. B) By Chemical |
I. R. Spectrum should be concordant with reference standard A solution (1 in 100) responds to flame test for sodium |
| Solubility (1% solution) | Soluble in water (carbon dioxide free) |
| pH (1% solution in water) | Limit : 4.2 to 5.2 |
| Water Content (By K.F.) | Limit: Max.5% |
| Phosphite | Limit : Max. 1% |
| Heavy Metals | Limit: Max.0.005% |
| Organic volatile Impurities | As per appendix (467), method 1 |
| Assay (By Titration) | Limit: 97 to 101% (On Dried Basis) |
| Ibandronate Sodium | |
| Specification | For : Ibandronate Sodium |
| Chemical Name | 1 Hydroxy 3(N ) Methly 3(N) n Pentylamino,1,1 Bisphosphonic Acid |
| Molecular Formula | C9H22O7NP2NaH2O |
| Molecular Weight | 359.17 |
| Test | Specification |
| Description | White crystalline powder |
| Solubility | Soluble in water, not soluble in alcohol |
| Loss on Drying | Limit : 4.5% - 8.5% |
| Chloride | Limit : Max. 0.005% |
| Sulphate | Limit : Max. 0.005% |
| Heavy Metals | Limit : Max. 0.001% |
| Related Substance | Limit : Max. 0.5% |
| Phosphite | Limit : Max. 0.3% |
| Assay (By HPLC) | Limit : Min. 99.5% |