Current API product portfolio
AcetazolamideSpecification:
|
|
| chemical name: | N-(5-sulphamoyl-1,3,4-thiadiazol-2-yl)acetamide |
| molecular formula: | C4H6N4O3S2 |
| structural formula: |  |
| molecular weight: | 222.2 |
| CAS Registery number: | 59-66-5 |
General information: A white or almost white, crystalline powder, very slightly soluble in water, slightly soluble in alcohol. It dissolves in dilute solutions of alkali hydroxides. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: A, B. Second identification: A, C, D. A. UV spectrum B. IR spectrum C. chemical identification D. chemical identification |
meets the tests conforms comparison with reference substance spectrum conforms conforms |
Ph. Eur. |
| Appearance of solution | solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution Y5 or BY5. | Ph. Eur. |
| Related substances (HPLC): - impurity A - impurity B - impurity C - impurity D - impurity E - impurity F - other unspecified impurity - total impurities |
not more than 0.15% not more than 0.15% not more than 0.15% not more than 0.15% not more than 0.15% not more than 0.15% not more than 0.10% not more than 0.6% |
Ph. Eur. |
| Sulphates | not more than 500 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 acetazolamide calculated on the dried substance | 98.5% - 101.0% | Ph. Eur. |
| Residual solvents - acetic acid - acetone 1) |
loss on drying less than 0.5% |
Ph. Eur. |
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