|
Tests |
Specification |
| Description |
White crystline Powder |
| Solubility |
Slightly soluble and water
and freely soluble in methanol |
| Identification |
By
IR Melting Point , Chromatogram |
| Melting
Point |
136oC
to 140oC |
| Heavy
Metals |
Not
more than 10PPM |
| Loss
on drying |
Not
more than 0.5% |
| Sulphate
Ash |
Not
more than 0.2% |
| Clarity
& Color of Solution |
A5%
w/v solution in methanol is clear colorless |
| Related
substance By HPLC |
[1]
Individual known impurity :
(i) Fluconazole Isomer : Not more than 0.2 %
[2] Total Impurities
Not more than 0.5 %
|
| Assay
by HPCL |
Not
less than 98.0 % and not more than 102.0 % w/w of C13H12F2N6O
calculated on dried basis |
