|
 |
 |
 |
Fluconazole |
Specifications |
| Description |
White
to off white crystalline powder |
| |
|
| Solubility |
Freely
soluble in Methanol. Soluble in Chloroform
and Glacial Acetic Acid. |
| |
|
| Identification
|
|
| |
|
| i)
IR |
The
IR spectrum of sample should be concordant
with that of standard. |
| |
|
| ii)
UV |
Absorption
spectrum of sample should be concordant with
that of standard |
| |
|
| Melting
Range |
136
to 140 Deg C |
| |
|
| Loss
on drying |
Not
more than 0.5% |
| |
|
| Sulphated
Ash |
Not
more than 0.2% |
| Heavy
Metals |
Not
more than 20 ppm |
| Purity
by HPLC |
Not
less than 99% |
| Related
individual impurity |
Not
more than 0.5% |
| Total
Impurities |
Not
more than 1.0% |
| Chemical
Assay |
98%
- 101% |
|
|
|
|
|
 |
|
