Current API product portfolio
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: White to off-white powder. Practically insoluble in water; soluble in alcohol and in acetone. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification - identification in IR |
corresponds to spectrum obtained with reference substance |
USP |
| X-ray diffraction | conforms to diffraction pattern of reference substance | USP |
| Acidity | not more than 1.0 ml of 0.010 N sodium hydroxide / g | USP |
| Alkalinity | not more than 1.0 ml of 0.010 N hydrochloric acid / g | USP |
| Loss on drying | not more than 0.5% | USP |
| Residue on ignition | not more than 1.0% | USP |
| Chlorides | not more than 0.014% | USP |
| Heavy me |
not more than 0.001% | USP |
| Chromatographic purity (HPLC): - 10,11-dihydrokarbamazepine - iminostilbene - other single impurity - total impurities |
not more than 0.2% not more than 0.2% not more than 0.2% not more than 0.5% |
USP |
| Residual solvents: - methanol - toluen - ethanol* |
not more than 1000 ppm not more than 500 ppm not more than 1000 ppm |
POLPHARMA |
| Content of carbamazepine calculated on dried substance | 98.0% - 102.0% | USP |
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