Current API product portfolio
Metoprolol tartrateSpecification:
|
|
| chemical name: | 1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt |
| molecular formula: | [C15H25NO3]2 . C4H6O6 |
| structural formula: |  |
| molecular weight: | 684.81 |
| CAS Registery number: | 56392-17-7 |
General information: White, crystalline powder. Very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; insoluble in ether. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification - IR spectrum |
comparison with reference substance spectrum |
USP |
| Specific rotation | + 6.50 to + 10.50 | USP |
| pH | 6.0 to 7.0 | USP |
| Loss on drying | not more than 0.5% | USP |
| Residue on ignition | not more than 0.1% | USP |
| Heavy me |
not more than 0.001% | USP |
| Chromatographic purity (TLC): - total impurities |
not more than 1.0% |
USP |
| Residual solvents: - acetone - toluene |
not more than 500 ppm not more than 100 ppm |
POLPHARMA |
| Content of metoprolol tartrate calculated on dried substance | 99.0% - 101.0% | USP |
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