| S.No | Test | Specification |
| 1. | Description |
A white to off white powder |
| 2. | Solubility |
IR absorption spectrum of sample should be concordant with standard |
| 3. | Melting point range |
Between 205°C and 211°C |
| 4. | Sulphated Ash |
Not more than 0.5% w/w |
| 5. | Loss on drying | Not more than 2.0%w/w |
| 6. | Chromatographic Purity by HPLC |
Not less than 98.0% |
| 7. | Assay of Hydrochloric acid | Between 11.0% and 15.0% on dried basis |
| 8. | Assay by chemical |
Not less than 98.0% w/w on dried basis |