Warfarin Sodium
CAS: 129-06-6
M.F.: C19H15NaO4
M.W.: 330.31
Specs: EP5.0/USP30
Product Name: Warfarin Sodium
CAS: 129-06-6
M.F.: C19H15NaO4
M.W.: 330.31
Specs: EP5.0/USP30
Appearance: White crystalline powder
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)
160~161.5
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)
800.00%
Water
≤0.3%
0.12%
Heavy metals
≤10ppm
Conforms
Absorbance in alkaline solution
≤0.1
9.00%
Chromatographic purity
Individual known impurity≤0.3%
0.00%
Individual unknown impurity≤0.1%
0.00%
Total impurity≤1.0%
0.01%
Isopropyl alcohol content
8.0%~8.5%
8.21
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%
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