|
LORATADINE |
| Product Name |
: |
Loratadine BP/EP/USP |
| Chemical Name |
: |
Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate |
| CAS Number |
: |
79794-75-5 |
| Chemical Formula |
: |
C22H23ClN2O2 |
| Molecular Mass |
: |
382.88 g/mol |
| Therapeutic Category |
: |
antidepressants |
| Test |
Specification |
| Description |
White off-white powder |
| Identification |
The IR absorption spectrum of the preparation of the test specimen, exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding Loratadine working standard The retention time of the major peak in the |
| Solubility |
Freely soluble in acetone, in chloroform, in methanol and in toluene, insoluble in water |
| Heavy Metals |
NMT 0.001 |
| Loss On Drying |
NMT 0.5 |
| Assay on dried basis by HPLC |
NLT 98.5 and NMT 101.0 |
| Related Substances by HPLC |
NMT 0.1 NMT 0.1 NMT 0.1 NMT 0.3 |
| Melting Range |
Between 132 and 137 |
| Additional Tests |
Tetrahydrofuran : NMT 500 Toluene : NMT 500 Di-isopropyl ether : NMT 500 Triethylamine : NMT 50 |
| Residue On Ignition |
NMT 0.1 |
|
|
