| Sr. No | Test | Specification | |
|---|---|---|---|
| 1 | Description | Off white or a Pale Yellow to Brown Powder | |
| 2 | Solubility | Insoluble in Water, Soluble in methanol | |
| 3 | Identification (by IR) | The Infra-red absorption spectrum of the substance being examined should be concordant with the spectrum obtained from NB-2 working standard. | |
| 4 | Melting Range | Between 155.0°C and 164.0°C | |
| 5 | Water content (by KF) | Not more than 1.0%w/w | |
| 6 | Loss on Drying (at 105°C for 3Hrs | Not more than 5.0%w/w | |
| 7 | Chromatographic purity (by HPLC % area normalization method) | Not less than 98.0% | |
| Impurity at 1.25 RRT | Not more than 2.0%w/w | ||
| Any other Impurity | Not more than 2.0%w/w | ||
