Current API product portfolio
AciclovirSpecification:
|
|
| chemical name: | 2-amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one |
| molecular formula: | C8H11N5O3 |
| molecular weight: | 225.2 |
| CAS Registery number: | 59277-89-3 |
General information: A white or almost white, crystalline powder, slightly soluble in water, freely soluble in dimethyl sulphoxide, very slightly soluble in ethanol (96 per cent). It dissolves in dilute solutions of mineral acids and alkali hydroxides. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: - IR spectrum |
comparison with reference substance spectrum |
Ph. Eur. |
| Appearance of solution (0.25 g/25 ml in 0.1 M NaOH) | solution is clear and not more intensely coloured than reference solution Y7 | Ph. Eur. |
| Related substances: a) thin-la - impurity A b) liquid chromatography (HPLC): - guanine - other single impurity - sum of other single impurities |
not more than 0.5% not more than 0.7% not more than 0.5% not more than 1.0% |
Ph. Eur. |
| Water | not more than 6.0% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of aciclovir calculated with reference to the anhydrous substance | 98.5% - 101.0% | Ph. Eur. |
| Residual solvents: - toluene - methanol - ethanol |
not more than 200 ppm not more than 600 ppm not more than 1000 ppm |
POLPHARMA |
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