S.No | Test | Specification |
1. | Description | An off-white to pale grey colour crystalline powder, hygroscopic |
2. | Solublity | Soluble in methanol and water. Insoluble in ethyl acetate. |
3. | Identification by IR | IR chromatograph of sample should be similar to In-house standard |
4. | Loss on drying | Not more than 1.0% |
5. | Purity by HPLC | |
a. Individual impurity | Not more than 0.5% | |
b. Total impurities | Not more than 1.0% | |
6. | Assay by Chemical | Not less than 98.0% |