Current API product portfolio
CarvedilolSpecification:
|
|
| chemical name: | (2RS)-1-(9H-Carbazol-4-yloxy)-3[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol |
| molecular formula: | C24H26N2O4 |
| molecular weight: | 406.5 |
| CAS Registery number: | 72956-09-3 |
General information: White or almost white, crystalline powder, practically insoluble in water, slightly soluble in alcohol, practically insoluble in dilute acids. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: - IR spectrum |
conformity with Ph.Eur. reference spectrum of carvedilol |
Ph. Eur. |
| Related substances (HPLC): - impurity A - impurity C - any other impurity - total impurities |
not more than 0.2% not more than 0.02% 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 carvedilol calculated on the dried substance | 99.0% - 101.0% | Ph. Eur. |
| Residual solvents: - ethyl acetate |
not more than 2000 ppm |
POLPHARMA |
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