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| Test | Specification |
|---|---|
| Description | White powder |
| Solubility | Freely soluble in acetone, in Chloroform, in methanol, and in toluene, insoluble in water. |
| Identification | By IR -The I.R Spectrum of the substance being examined in mineral oil is concordant with the IR spectrum obtained from Loratadine working standard By HPLC - The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
| Melting Range | Between 132 oC and 137 oC |
| Loss on drying | Not more than 0.5 % (w/w) |
| Residue on Ignition | Not more than 0.1 % (w/w) |
| Heavy Metals | Not more than 10 ppm. |
| Related substances (By HPLC) | Impurity-A* - Not more than 0.2 % Unknown impurity - Not more than 0.1 % Total Impurities - Not more than 0.3 % |
| Assay ( by Titrimetry ) | Not less than 98.5 % and not more than 101.0 % of Loratadine, calculated on dried basis. |
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Ankleshwar gidc, Ankleshwar, Gujarat 
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