Current API product portfolio
Metoprolol succinateSpecification:
|
|
| chemical name: | (4-amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt trihydrate |
| molecular formula: | C34H56N2O10 |
| structural formula: |  |
| molecular weight: | 653 |
| CAS Registery number: | 98418-47-4 |
General information: Appearance: white, crystalline powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Idetyfication: IR spectrum |
comparison with reference substance spectrum |
Ph. Eur. |
| Appearance of solution (20mg/ml) | solution is not more opalescent than reference suspension II and it is colourless | Ph. Eur. |
| pH of solution (20 mg/ml) | 7.0 - 7.6 | Ph. Eur. |
| Related substances: A. TLC - single impurity B. HPLC - single impurity - total impurities |
not more than 0.2% not more than 0.1% not more than 0.5% |
Ph. Eur. |
| Heavy me |
not more than 10 ppm | Ph. Eur. |
| Loss on drying | not more than 0.5% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of metoprolol succinate calculated on dried substance | 99.0% to 101.0% | Ph. Eur. |
| Residual solvents: - acetone - toluene |
not more than 2500 ppm not more than 100 ppm |
POLPHARMA |
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