Loratadine usp
 
Product Name LORATADINE USP
IUPAC Name Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b] pyridine -
11-ylidene)-1-piperidinecarboxylate
C.A.S. No 79794-75-5
Molecular Formula C22H23ClN2O2
Formula Weight 382.88
Therapeutic category Allergy

SR. NO.
TEST
SPECIFICATION
1
Description
  White to off white powder
2
Solubility
  Freely soluble in acetone, in chloroform, in methanol
  and in toluene, insoluble in water
3

Identification:
A. By IR

 

 

B. By HPLC

  A. The infrared absorption spectrum of the
  substance being examined in mineral oil should
  be concordant with the Infrared absorption
  spectrum obtained from Loratadine working
  standard.

  B. 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

4
Melting range
  Between 132°C and 137°C
5
Loss of drying (105oC/3 hrs.)
  Not more than 0.5 % w/w
6
Residue on ignition
  Not more than 0.1 % w/w
7
Heavy metals
  Not more than 0.001 %
8

Related substances (By HPLC)
(1) 4-(8-chloro-11-fluoro-6,11-dihydro-
5H -benzo[5,6] cyclohepta[1,2-
b]pyridin-11-yl)-piperidinecarboxylate
ethyl.
(2) Unknown impurity

(3) Total impurities

  

 

 

Not more than 0.2%
 

Not more than 0.1 %
Not more than 0.3 %

9
Assay (By HPLC)
  98.5 % to 101.0 % of C22H23ClN2O2, calculated on
  the dried basis

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