Wafarin sodium USP
Item | Specifications | Result |
Description | White crystalline powder | Conforms |
Identification | a. IR spectrum exhibits maximum only at the same wavelengths as that of the USP reference standard | Conforms |
b. Melting range of the obtained warfarin: 157° to 167°(range should not exceed 4°) | 160°~162° | |
c. A solution of it responds to the test for sodium. The filtrate obtained in identification B responds to the flame test for sodium. | Conforms | |
PH | 7.2 to 8.3 (1 in 100solution) | 8.0 |
Water | ≤0.3% | 0.10% |
Heavy metals | ≤10ppm | Conforms |
Absorbance in alkaline solution | ≤0.1 | 0.09 |
Chromatographic purity | Individual known impurity≤0.3% | 0.003% |
Individual unknown impurity≤0.1% | 0 | |
Total impurity≤1.0% | 0.006% | |
Isopropyl alcohol content | 8.0%~8.5% | 8.26 |
Organic volatile impurity | Comply the USP requirements | Conforms |
Residual solvents | Ethanol ≤1000ppm | Conforms |
Acetone ≤1000ppm | Conforms | |
Assay (on the anhydrous isopropyl alcohol-free basis) | 97.0-102.0% | 99.99% |
warfarin sodium