Chemical Name

3-(3-oxo-1-phenylbutyl)coumarin sodium salt

CAS Number

129-06-6

Molecular Formula

C19H15NaO4

Molecular Weight

330.31

Storage

Store in a cool, dry place, away from direct heat and light.

Application

Warfarin Sodium can be used as pharmaceutical and pharmaceutical chemical. It is an anticoagulant medication.

It is used for the prophylaxis of thrombosis and embolism in many disorders. Its activity has to be monitored by frequent blood testing for the international normalized ratio (INR).

Items

Specification

Appearance

White crystalline powder

Identification

Meets the requirements

Melting Point

157 ~ 167

Item

Results

Unit

Acceptance Criteria

Appearance

White crystalline powder

-

White crystalline powder

Particle size d(0.5)

6

μm

≤20

Identification

HPLC

Positive

-

The retention time of the major peak in the chromatogram of the assay preparetion corresponds to that of the standard preparetion, as obtained in the assay.

IR

Positive

-

The infrared absorption spectrum of the test specimen should correspond to the spectrum of warfarin standard specimen.

Absorbance in alkaline solution

0.02

-

≤0.1

PH

7.9

-

7.2~8.3

Water

0.1

%

≤0.3

Heavy metals

< 0.001

%

≤0.001

Assay,on the anhydrous and isopropyl alcohol free basis

100.3

%

97.0~102.0

Chromatographic

Related compound A

N.D.

%

≤0.3

Impurity B

N.D.

%

≤0.1

Impurity C

N.D.

%

≤0.1

Single unspecified impurity

0.002

%

≤0.1

Total impurity

0.01

%

≤1.0

Residual solvents

Ethanol

655

ppm

≤5000

Acetone

N.D.

ppm

≤5000

Triethylamine

N.D.

ppm

≤320

Isopropyl alcohol content

8.2

%

8.0~8.5

Microbial limits

Total aerobic microbial count

< 1

CFU/g

≤100

Total combined yeasts/moulds count

< 1

CFU/g

≤50

Escherichia coli

Absent

-

Absent/g

Conclusion: The batch is in compliance with USP41.