| 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. |
