Current API product portfolio
Opipramol dihydrochlorideSpecification:
|
|
| chemical name: | dihydrochloride 5-[3-(N'-b-hydroxyethylpiperazino)propyl}-5H dibenz[b,f]-azepine |
| molecular formula: | C23H29N3O, 2HCl |
| structural formula: |  |
| molecular weight: | 436.44 |
| CAS Registery number: | 909-39-7 |
General information: Opipramol dihydrochloride is a yellow to green-yellow amorphous powder, darkening on exposure to light, freely soluble in water and slightly soluble in ethanol. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| pH of solution (10 mg/ml) | 2.4 to 3.0 | Ph. Eur. |
| Identification: - UV spectrum - IR spectrum - chemical identification |
maximum at 254 nm ± 2 nm ( is about 670) comparison with reference substance spectrum conforms |
POLPHARMA |
| Chromatographic purity (HPLC): - iminostilbene - any other impurity - total impurities |
not more than 0.05% not more than 0.10% not more than 0.5% |
POLPHARMA |
| Heavy me |
not more than 0.001% | USP |
| Loss on drying | not more than 0.5% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of opipramol dihydrochloride calculated on the dried substance | 98.0% to 101.0% | POLPHARMA |
| Residual solvents: - me - acetone - toluene |
not more than 3000 ppm not more than 5000 ppm not more than 890 ppm |
POLPHARMA |
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