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PentoxifyllineSpecification:
|
|
| chemical name: | 3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydro-1H-purine-2,6-dione |
| molecular formula: | C13H18N4O3 |
| structural formula: |  |
| molecular weight: | 278.3 |
| CAS Registery number: | 6493-05-6 |
General information: Appearance: white or almost white, crystalline powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: A, B Second identification: A, C, D A. melting point B. IR spectrum C. TLC D. chemical identification (reaction of xanthines |
103°C to 107°C comparison with reference substance spectrum the principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution conforms |
Ph. Eur. |
| Appearance of solution | the solution is clear and not more intensely coloured than reference solution Y7 | Ph. Eur. |
| Acidity | conforms | Ph. Eur. |
| Related substances: - impurity A, C, F - impurity J - any other impurity - total 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 100 ppm | Ph. Eur. |
| Sulphates | not more than 200 ppm | 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 pentoxifylline calculated on dried substance | 99.0% - 101.0% | Ph. Eur. |
| Residual solvents: - 2-propanol - 2-cyclohexane - toluene - dimethylformamide - acetic acid |
not more than 1000 ppm not more than 380 ppm not more than 200 ppm not more than 400 ppm not more than 500 ppm |
POLPHARMA |
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