| 01. |
Description |
A White crystalline powder |
| 02. |
Identification
|
|
A. By IR Spectroscopy
|
Compare the spectrum of Fusidic acid WRS.
|
|
B. By Thin Layer Chromatography
|
The principal spot in the chromatogram obtained with the test solution
corresponds to that in the chromatogram obtained with the reference solution.
|
| 03. |
Solubility |
Freely soluble in ethanol (95%) and in chloroform,
sparingly soluble in ether, practically insoluble in water.
|
| 04. |
Assay by HPLC
(Anhydrous Basis)
|
NLT 97.5% - NMT 101.0%
|
| 05. |
Water Content % |
1.4% to 2.0% |
| 06. |
Sulfated Ash |
NMT 0.2% |
| 07. |
Related Substance by HPLC |
In the chromatography obtained with the test solution, the sum of the
areas of any secondary peak is not greater than 4 times the area of the
peak corresponding to fusidic acid in the chromatogram obtained with
reference solution.
|
