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: Appearance: white, crystalline powder or colourless crystals. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. specific rotation B. IR spectrum |
conforms comparison with reference substance spectrum |
Ph. Eur. |
| Appearance of solution | solution S is clear and not more intensely coloured than reference solution B8 | Ph. Eur. |
| pH | 6.0 to 7.0 | Ph. Eur. |
| Specific rotation | + 7.00 to + 10.00 | Ph. Eur. |
| Related substances: A. TLC - single impurity B. HPLC - single impurity (A to J) - total impurities |
not more than 0.5% (only one such impurity is more than 0.2%) not more than 0.3% 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 tartrate calculated on dried substance | 99.0% to 101.0% | Ph. Eur. |
| Residual solvents: - acetone - toluene |
not more than 500 ppm not more than 100 ppm |
POLPHARMA |
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