| S.No |
Test |
Specification |
Result |
| 1.0 |
Appearance |
White or almost white Crystalline powder |
Whit Crystalline powder |
| 2.0 |
Solubility |
Very soluble in waer freely soluble in ethanol (96%) soluble in acetone very slightly soluble in methylene
chloride |
Complies |
| 3.0 |
Identification |
| 3.1 |
IR |
The infra red absorption spectrum of the rest sample should exhibit maximaonly at the same wave lengths as that of a similar preparation of Warfarin working standard |
Complies |
| 3.2 |
Dichromate test |
Should comply EP |
Complies |
| 3.3 |
Test for sodium |
Should comply EP |
Complies |
| 4.0 |
Apprarence solution |
Solution should be clear and
Colourless |
Clear and Colourless |
| 5.0 |
pH |
7.6 to 8.6 |
8.09 |
6.0
|
Related substances by HPLC (in %) |
| 6.1 |
Impurity –B |
NMT 0.1 |
Not Detected |
| 6.2 |
Impurity – C |
NMT 0.1 |
Not detected |
| 6.3 |
Unspecified
impurities |
NMT 0.10 |
Not detected |
| 6.4 |
Total Impurities |
NMT 0.10 |
Not detected |
| 7.0 |
Isopropyl alcohol Content by C(%w/w) |
NLT 8.0 and NMT 8.5 |
8.2 |
| 8.0 |
Phenolic ketores |
NMT 0.20 |
0.06 |
| 9.0 |
Water (%w/w) |
NMT 0.03 |
0.16 |
| 10.0 |
Assay by UV
(%w/w)basis |
98.0 to 102.0 on anhydrous |
99.3 |
| 11.0 |
Microbial Concamation |
| 11.1 |
Total Viable aerobic count |
NMT 1000/g |
Complies |
| 11.2 |
Fungi |
NMT 100/g |
Complies |
| 11.3 |
Escherichia coli |
Absence/g |
Absent |
| |
|
|
|
