Product specification
| Parameter | Specification |
|---|---|
| Characteristics | White or yellowish, crystalline powder. Slightly soluble in water, in acetone, in alcohol and in methylene chloride. 99.0% to 101.0% (dried basis) Conforms to Ph. Eur. Tests 159 °C to 163 °C As per Ph. Eur.test: The solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution GY6 Not more than 0.1% Not more than 0.2% Not more than 20ppm Not more than 0.5% Not more than 0.1% Non-hazardous chemical Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. Metronidazole Benzoate Ph. Eur. PRODUCT SPECIFICATION CHARACTERISTICS Content Identification Melting point Appearance of solution Acidity Heavy metals Loss on drying Sulphated ash Impurity A (Metronidazole) Impurity B (2-methyl-4-nitroimidazole) Impurity C (benzoic acid) Other impurities Total impurities HAZARDOUS IDENTIFICATION STORAGE White or slightly yellowish, crystalline powder or flakes. Practically insoluble in water, freely soluble in methylene chloride, soluble in acetone, slightly soluble in alcohol. 98.5% to 101.0% (dried basis) Conforms to Ph. Eur. tests 99 o C - 102 o C As per Ph. Eur. test: The solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution GY₃ |
| Assay | As per Ph. Eur. test: Not more than 0.25 ml of 0.02 M sodium hydroxide is required to change the colour of the indicator |
| Identification | Not more than 20ppm |
| Melting point | Not more than 0.5% |
| Appearance of solution | Not more than 0.1% |
| Any impurity | Not more than 0.1% |
| Total impurities | Not more than 0.1% |
| Heavy metals | Not more than 0.1% |
| Loss on drying | Not more than 0.1% (each) |
| Sulphated ash | Not more than 0.2% |
| Hazardous Identification | Non-hazardous chemical |
| Storage | Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. |