|
S.No. |
TEST |
SPECIFICATION |
|
01. |
Description
|
A white to off white crystalline powder. |
| 02. |
Solubility |
Freely
soluble in Methanol, soluble in Chloroform and Acetic Acid |
| 03 |
Identification
a) IR
b)UV
|
The Infra Red absorption spectrum of the finely ground sample in KBr
dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of a similar preparation of FLUCONAZOLE working standard
The UV Absorption spectrum of 0.002% solution in water exhibits maxima at 261
+ 2nm
|
| 04. |
Melting Range |
Between
137o C and 141o C |
| 05. |
Loss of Drying |
Not more than 0.5% w/w |
| 06. |
Sulphated ash |
Not more than 0.2% w/w |
| 07. |
Heavy
Metals |
Not more than
0.002% w/w |
| 08. |
Chromatographic purity
(by HPLC) |
Maximum single impurity : Not more than 0.5 %
Total Impurities : Not more than 1.0% |
| 09. |
Assay on dried basis
(by titrimetry) |
Should be between 98.0% and102.0% w/w.
|
