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CarbamazepineSpecification:
|
|
| chemical name: | 5H-dibenz[b,f]azepine-5-carboxamide |
| molecular formula: | C15H12N2O |
| structural formula: |  |
| molecular weight: | 236.3 |
| CAS Registery number: | 298-46-4 |
General information: Appearance: white or almost white, crystalline powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: a) melting point b) IR spectrum |
189°C to 193°C corresponds to reference substance spectrum |
Ph. Eur. |
| Acidity or alkalinity acc. to Ph. Eur. | acc. to Ph. Eur. | Ph. Eur. |
| Related substances (HPLC): - 10,11-dihydrocarbamazepine (impurity A) - iminodibenzyl (impurity E) - other single impurity - sum of impurities |
not more than 0.1% not more than 0.1% not more than 0.10% not more than 0.5% |
Ph. Eur. |
| Chlorides | not more than 140 ppm | Ph. Eur. |
| Heavy me |
not more than 20 ppm | Ph. Eur. |
| Loss on drying | not more than 0.5% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of carbamazepine calculate on dried substance | 98.0% to 102.0% | Ph. Eur. |
| Residual solvents: - methanol - toluen - ethanol* |
not more than 1000 ppm not more than 500 ppm not more than 1000 ppm |
POLPHARMA |
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