S.No | Test | Specification |
1 | Description | An off-white to light brown colour crystalline powder |
2 | Solubility | Soluble in methanol, acetone. Sparingly soluble in water. Insoluble in toluene and dichloromethane |
3 | Identification by IR | The sample and standard IR spectra are concordant |
4 | Melting range | 170.0°C to 180.0°C |
5 | Heavy Metals | Not more than 20 ppm |
6 | Loss on drying | Not more than 0.5% w/w |
7 | Purity by HPLC | Not less than 99.00% |
8 | Assay by HPLC | Not less than 98.00% |