| Test |
Specification |
Result |
| Description |
White odorless crystalline powder having a slightly bitter taste, is Discoloured by light |
White odorless Crystalline
powder having a slightly bitter
taste is discoloured by light |
| Solubility |
Very soluble in water freely soluble in alcohol and very slightly soluble in Chloroform and ether. |
Complies |
| pH |
7.2 – 8.3 |
7.33 |
| Identification |
|
|
| Melting point |
157°C – 167°C |
160.1°C – 161.1°C |
Absorbance in Alkaline
Solution |
NMT 0.1 |
0.07 |
| Water by KF |
NMT 0.3% |
0.20% |
| Chromotographic Purity: |
| 1)Warfarin Related Compound –A |
Not more than 0.3% |
Not Detected |
| 2)Any Individual Impurity |
Not more than 0.3% |
Not detected |
| 3)Total Impurities |
Not more than 1.0% |
Not detected |
| IPA Content by GC |
NLT 8.0% and NMT 8.5% |
8.32% |
Assay by HPLC on
Anhydrous and IPA free
basis |
NLT 97.0% and NMT 102.0% |
101.03% |
| Residual Solvents |
|
|
| Methanol |
NMT 3000 ppm |
Complies |
| Toluene |
NMT 890 ppm |
Complies |
| |
|
|
