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Home Active Pharmaceutical Ingredients 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

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
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