| |
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|
| S.No |
Test |
Specification |
Result |
| 1.0 |
Description |
A white odorless, amorphous Powder
Having a slightly bitter taste. Is
discoloured by light |
A white odorless
amorphous powder having a slightly bitter taste Is discoloured by light |
| 2.0 |
Solubility |
Very soluble in water, freely soluble
In alcohol and very slightly soluble in chloroform and in ether |
Complies |
| 3.0 |
pH of a Solution |
7.2 – 8.3 |
7.8 |
| 4.0 |
Identification |
| 4.1 |
By IR |
The infra red absiorption spectrum ofthe test sample should exhibit maxima only at the same wave lengths as that of a similar preparation of Warfarin working standard |
Complies |
| 4.2 |
Test for Sodium |
Warfarin Sodium should impart an intense yellow color to nonluminous flame |
Complies |
| 4.3 |
Melting Range (°C) |
157 – 167 |
159.4 – 161.2 |
| 5.0 |
Absorbance in alkaline
solution |
NMT 0.1 |
0.08 |
| 6.0 |
Water by KF (% w/w) |
NMT 4.50 |
1.40 |
| 7.0 |
Heavy Metals (%) |
NMT 0.001 |
Less than 0.001 |
| 8.0 |
Chromatographic Purity (in %) |
|
|
| 8.1 |
Individual Impurity |
NMT 0.3 |
Not detected |
| 8.2 |
Total Impurities |
NMT 1.0 |
Not detected |
| 8.3 |
Assay by HPLC(on anhydrous basis)(%w/w) |
97.0 – 102.0 |
100.3 |
| 9.0 |
Residual Solvents
GC (in ppm) |
|
|
| 9.1 |
Methanol |
NMT 3000 |
1314 |
| 9.2 |
Isopropyl alcohol |
NMT 5000 |
720 |
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