Product Name : DEFLAZACORT
Molecular Formula :C 25 H 31 NO6
Molecular Weight : 441.52
Synonyms :Azacort, Oxazacort, Deflan, Calcort, Deflanil, Lantadin, Deflazacortum, Enzocort
CAS No : 14484-47-0
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | White or almost white fine powder |
| 2 | Solubility | Sparingly soluble in ethanol, methanol, acetone and very slightly soluble in water. |
| 3 | Identification By IR By HPLC |
The IR spectrum of sample should be in concordant with
that of Deflazacort working standard. The retention time of major peak in the chromatogram of assay preparation should corresponds to that in the chromatogram of standard preparation as obtained in the assay. |
| 4 | Loss on Drying | Not more than 0.5% w/w |
| 5 | Loss on drying (% w/w) | Not more than 0.5 |
| 6 | Related substances Individual impurity Total impurities |
Not more than 0.5% Not more than 1.0% |
| 7 | Specific Optical Rotation | Between + 58’ and + 68’ |
| 8 | Assay | 98.0% to 102.0% calculated on dried basis |
| 9 | Melting Point | Between 252’ C and 258’C |
| 10 | Sulphated Ash | Not more than 0.1% |
| 11 | Sieve test | 100% material should pass through #80 mesh. |
| 12 | Heavy metals | Not more than 20 ppm. |