| S.No |
Test |
Specification |
Result |
| 1.0 |
Appearance |
A white powder hydroscopic |
White powder hydroscopic |
| 2.0 |
Solubilitry |
Very soluble in water and in alcohol Soluble in acetone, very slightly
Soluble in methylene chloride |
Complies |
| 3.0 |
Identification |
| 3.1 |
Melting Point of A residue (in °C) |
159 – 163 |
160.1 – 161.8 |
| 3.2 |
IR |
The IR absorption spectrum of the precipitate by infra red absorption spectrometry comparing with the spectrum obtained with the precipitate prepared in the same manner from warfarin Sodium WS |
Complies |
| 3.3 |
By TLC |
The principal spot in the Chromatogram obtained with the test solution(b) is similar in position and size to the principal spot in the Chromatogram obtained with Reference solution (b) |
Complies |
| 3.4 |
Dichromate test |
Solution is not greenish blue when compared with blank |
Complies |
| 3.5 |
Test for Sodium |
No precipitate is formed |
Complies |
| 4.0 |
Appearance of Solution |
The Solution is clear and colourless |
Complies |
| 5.0 |
pH(1% solution) |
Betweeen 7.6 and 8.6 |
7.90 |
| 6.0 |
Related Substances
by TLC |
any spot in the Chromatogram obtained with test solution (a), apart from principal spot, is not moreintense than the spot in the Chromatogram obtained with reference solution (a) (0.1%) |
Complies |
| 7.0 |
Phenolic ketones |
The absorbance at 385mm with in 15 mins not greater than 0.20 |
0.08 |
| 8.0 |
Water (% w/w) |
Not more than 4.0 |
2.28 |
| 9.0 |
Assay on anhydrous basis (% w/w) |
98.0 – 102.0 |
100.8 |
| ADDITIONAL TESTS |
| 10.0 |
Heavy metals (in ppm) |
Not more than 10 |
Less than 10 |
| 11.0 |
HPLC Purity in % |
Not less than 99.4 |
100.0 |
| 11.2 |
Benzalacteone |
Not more than 0.10 |
Not detected |
| 11.3 |
Each other impurity |
Not more than 0.10 |
Not detected |
| 11.4 |
Sum of all other
impurities |
Not more than 0.40 |
Not detected |
| 11.5 |
Total impurities |
Not more than 0.60 |
Not detected |
| 12.0 |
Residual Solvents (in %) |
| 12.1 |
Methanol |
Not more than 0.1 |
0.089 |
12.2
|
Acetone |
Not more than 0.1 |
Not detected |
| 12.3 |
Tert – Butyl Methyl ether |
Not more than 0.2 |
Not detected |
| 13.0 |
Bulk density (g/ml) |
0.20 - 0.60 |
0.52 |
| 14.0 |
Tapped density |
0.40 – 0.80 |
0.77 |
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