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Bulk Active : Desloratadine
MOLECULAR FORMULA : C19H19ClN2
MOLECULAR WEIGHT : 310.82
Pharmacologic Activity :
Anti-allergy
CAS No : 100643 -71 - 8
Specifications : In-house
Regulatory compliance : Under preparation
| TEST | SPECIFICATION |
| Appearance | White to off white powder |
| Solubility | Soluble in DMF, Methanol, chloroform, dichloromethane and insoluble in water |
IDENTIFICATION A.IR B-H.P.L.C |
Should be concordant with IR spectrum of Desloratadine CRS. In the test for assy the retention time of the principal peak from the sample should be match with that from Desloratadine working standard. |
| Melting Range | 151.0 °C to 158.0 °C |
| Loss on drying |
Not more than 0.5% w/w |
| Water | Not more than 0.5% w/w |
| Residue on Ignition | Not more than 0.2 % w/w |
| Heavy metals | Not more than 20 ppm |
| Related substances by HPLC ( % ) |
Single max. impurity : NMT 0.5 % Total Impurities : NMT 1.0 % |
| Assay By HPLC ( % ) | 98.0 to 102.0 % w/w on dried basis |
