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Home Active Pharmaceutical Ingredients desloratidine
Product Name : Desloratidine BP/EP/USP
Chemical Name : 8-chloro-6,11-dihydro-11-(4-piperdinylidene)- 5H-benzo [5,6] cyclohepta[1,2-b]pyridine
CAS Number : 100643-71-8?
Chemical Formula : C19H19ClN2
Molecular Mass : 310.82 g/mol
Therapeutic Category : Antihistamine

Test Specification
Description A White to light brown colored crystalline powder
Identification The IR spectrum of the sample recorded as KBr pellet is concordant with similarly recorded spectrum of working standard.
Solubility Freely soluble in methanol.
Heavy Metals Not more than 20 ppm
Assay on dried basis by HPLC Not less than 99.0% and NMT 101.0%
Water Content by KF NMT 1.0%
Sulphated Ash Not more than 0.10% w/w
Melting Range Between 152 & deg to 159 & deg
Additional Tests

Single Max Impurity: N MT 0.10 %

Total Impurities: NMT 0.30 %

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