Rupatadine Fumarate
 
Product Name RUPATADINE FUMARATE
IUPAC Name 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridyl)methyl]-4-piperidylide ne]-5h-benzo[5,6]cyclohepta[1,2-b]pyridine
C.A.S. No 158876-82-5
Molecular Formula C30H30ClN3.O4
Formula Weight 532.03
Therapeutic category Antihistamine


SR.
NO.
TEST
SPECIFICATION
1
Description
  White to slight pinkish powder
2
Solubility
  Sparingly soluble methanol
3
Identification:
By HPLC
  The retention time of the major peak in the chromatogram
  of the sample Preparation corresponds to that in the
  chromatogram of the working Standard preparation, as
  obtained in the related substance.
4
pH (1 % w/v suspension in water)
  Between 4.0 to 5.0
5
Loss on drying
  Not more than 1.0 % w/w
6
Residue on ignition
  Not more than 0.20 % w/w
7
Heavy metals
  Not more than 20 ppm
8
Related substance (By HPLC)
- Total impurity.
  Not more than 1.50 %
9
Assay (By Titration)
On dried basis
  Not less than 98.0 % w/w and Not more than 102.0 %
  w/w.

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