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