S.No |
Test |
Specification |
1. |
Description |
A white to creamish white coloured crystalline powder |
2. |
Solubility |
Soluble in methylene chloride and methanol |
3. |
Identification by IR |
IR absorption spectrum of sample should be concordant with standard |
4. |
Loss on drying (At 60°C under vacuum) |
Not more than 1.0 %w/w |
5. |
Sulphated ash |
Not more than 0.5%w/w |
6. |
Related impurities by HPLC |
|
1. 2-Hydroxy methyl -3,5- dimethyl- 4-methoxy pyridine |
Not more than 0.5% |
2. 4-Hydroxy-2-chloromethyl-3,5-dimethyl pyridine HCl |
Not more than 0.5% |
3. Any Unknown Impurity |
Not more than 0.5% |
4. Total impurities |
Not more than 2.0% |
7. |
Assay by chemical |
Not less than 98.0% w/w on dried basis |