Current API product portfolio
MetronidazoleSpecification:
|
|
| chemical name: | 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethanol |
| molecular formula: | C6H9N3O3 |
| structural formula: |  |
| molecular weight: | 171.2 |
| CAS Registery number: | 443-48-1 |
General information: Appearance: A white or yellowish, crystalline powder, slightly soluble in water, in acetone, in alcohol and in methylene chloride. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: C Second identification: A, B, D - melting point - UV-Vis spectrum - IR spectrum - chemical identification |
159°C to 163°C the specific absorbance at the maximum is 365 to 395 comparison with reference substance spectrum conforms |
Ph. Eur. |
| Appearance of solution | the solution is not more opalescent than reference suspension II and not moreintensely coloured than reference solution GY6 | Ph. Eur. |
| Related substances (HPLC): - any impurity - total impurities |
not more than 0.1% not 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 metronidazole calculated on dried substance | 99.0% to 101.0% | Ph. Eur. |
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