Current API product portfolio
Alendronate sodiumSpecification:
|
|
| chemical name: | (4-amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt |
| molecular formula: | C4H12NNaO7P2, 3H2O |
| structural formula: |  |
| molecular weight: | 325.1 |
| CAS Registery number: | 121268-17-5 |
General information: White, free-flowing powder. Soluble in water; practically insoluble in dimethyl sulfoxide, in methyl alcohol, in propylene glycol, in acetone, in acetonitrile, in alcohol, in chloroform, and in isopropyl alcohol. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR spectrum B. Chemical identification |
corresponds to reference substance spectrum gives reaction of sodium |
USP |
| Loss on drying | 16.1% to 17.1% | USP |
| Heavy me |
not more than 0.001% | USP |
| Related substances: - single impurity - total of impurities |
not more than 0.1% not more than 0.5% |
USP |
| Content of alendronate sodium calculated on dried substance | 98.0% - 102.0% | USP |
| Residual solvents: - methanol |
not more than 500 ppm |
POLPHARMA |
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