Current API product portfolio
Risedronate sodiumSpecification:
|
|
| chemical name: | [1-hydroxy-2-(3-pyridinyl)ethylidene bis-phosphonic acid monosodium salt hemi-pentahydrate |
| molecular formula: | C7H10NO7P2Na; 2.5HO |
| structural formula: |  |
| molecular weight: | 350.1 |
| CAS Registery number: | 115436-72-1 |
General information: Risedronate sodium is a white or off-white, fine-crystalline powder, soluble in water and in dilute alkaline solutions, practically insoluble in methanol and methylene chloride. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| - IR spectrum - chemical (Na+) |
comparison with reference substance spectrum conforms |
Ph. Eur. |
| pH | 4.0 – 5.0 | Ph. Eur. |
| Chromatographic purity (HPLC): - 3-PAA (impurity A) - 2-RIS (impurity B) - 4-RIS (impurity C) - single impurity - sum of impurities |
not more than 0.15% not more than 0.15% not more than 0.15% not more than 0.10% not more than 0.30% |
POLPHARMA |
| Phosphate and phospite (HPLC) - phosphate - phosphite |
not more than 0.15% not more than 0.15% |
POLPHARMA |
| Heavy me |
not more than 20 ppm | Ph. Eur. |
| Loss on drying | 12.2% - 13.6% | Ph. Eur. |
| Assay of sodium risedronate calculated on the dried substance (potentiometric titration) | 98.0% - 102.0% | |
| Residual solvents: - methanol - benzene |
not more than 500 ppm not more than 2 ppm |
POLPHARMA |
| Particle size | for information D (v; 0.5) D (v; 0.9) |
POLPHARMA |
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