Current API product portfolio
TinidazoleSpecification:
|
|
| chemical name: | 1-[2-(ethylsulphonyl)ethyl]-2-methyl-5-nitro-1H-imidazole |
| molecular formula: | C8H13N3O4S |
| structural formula: |  |
| molecular weight: | 247.3 |
| CAS Registery number: | 19387-91-8 |
General information: An almost white or pale yellow, crystalline powder, practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: A, C Second identification: A, B, D, E |
meets the tests meets the tests |
Ph. Eur. |
| Appearance of 5% solution in acetone | the solution is clear and not more intensely coloured than reference solution Y5 | Ph. Eur. |
| Related substances (TLC): - impurity A - impurity B - other single impurity |
not more than 0.5% not more than 0.5% not more than 0.5% (at most one such impurity more than 0.2%) |
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 tinidazole calculated on dried substance | 98.0% to 101.0% | Ph. Eur. |
| Residual solvents: - methylene chloride - 2-propanol - isobutyl methyl ketone |
not more than 100 ppm not more than 250 ppm not more than 100 ppm |
POLPHARMA |
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