S.No |
Test |
Specification |
1. |
Description |
A white to off-white colour powder and hygroscopic in nature |
2. |
Solublity |
Soluble in methanol and water. Insoluble in dichloro-methane and benzene |
3. |
Identification by IR |
The sample and standard IR spectra are concordant |
4. |
Melting range |
Between 157°C and 163°C |
5. |
Loss on drying |
Not more than 2.0% |
6. |
Sulphated ash |
Not more than 1% |
7. |
Moisture content |
Not more than 0.5% |
8. |
related impurities by HPLC |
|
1. single impurity |
Not more than 0.5% |
2. total impurities |
Not more than 1.0% |
9. |
Assay by Chemical on dry basis |
Not less than 98.0% and not more than 102.0% |