| Product Name | DESLORATADINE |
| IUPAC Name | 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H- benzo [5,6] cyclohepta [1,2,b]pyridine |
| C.A.S. No | 100643-71-8 |
| Molecular Formula | C19H19ClN2 |
| Formula Weight | 310.83 |
| Therapeutic category | Antihistamine |
SR. NO. |
TEST
|
SPECIFICATION
|
1 |
Description |
White to off white powder |
2 |
Solubility |
Practically insoluble in water, soluble in methanol and chloroform |
3 |
Identification: By IR |
The infrared absorption spectrum of the substance being examined in mineral oil should be concordant with the Infrared absorption spectrum obtained from Desloratadine working standard. |
4 |
Melting range |
Between 150°C to 160°C |
5 |
Loss of drying (105oC/3 hrs.) |
Not more than 1.0 % w/w |
6 |
Residue on ignition |
Not more than 0.2 % w/w |
7 |
Heavy metals |
Not more than 20 ppm |
8 |
Related substances (By HPLC) 1 Single impurity 2 Total impurities |
Not more than 0.5 % |
9 |
Assay (By HPLC) |
98.0 % to 101.0 % of C19H19ClN2, calculated on the dried basis |
10 |
Additional test Residual solvent (By GC) Methyl alcohol |
Not more than 3000 ppm. |
