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)

8.0

Water

≤0.3%

0.12%

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%

8.21

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%