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Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) .
Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some people histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some people to have hives, with severe itching of the skin .
Specification:
|
PARAMETERS |
LIMITS |
RESULTS |
|
|
Description |
whiter crystalline powder |
whiter crystalline powder |
|
|
Solubility |
soluble in methanol and in dilute alkali solutions |
Complies |
|
|
Identification |
IR |
To Comply |
Complies |
|
HPLC |
To Comply |
Complies |
|
|
Melting range |
191 to 198 Degree |
192 to 196 Degree |
|
|
Loss on drying |
Not more than 1.0% w/w |
0.07% w/w |
|
|
Chlorides |
6.46 to 6.66% w/w |
6.57% w/w |
|
|
Residue on ignition |
Not more than 0.1% |
0.04% |
|
|
Heavy metals |
Not more than 20ppm |
Complies |
|
|
Related substances(HPLC) |
Not more than 0.50% |
0.21% |
|
|
Total impurity Assay(HPLC) |
Not more than 1.00% |
0.54% |
|
|
Residual solvents (GC) |
98.0 to 102.0% w/w |
98.71% w/w |
|
|
Isopropyl Alcohol |
Not more than 5000ppm |
3727.50ppm |
|
|
Ethyl Acetate |
Not more than 5000ppm |
764.79ppm |
|
|
Particle Size (Malvern) |
90% less than 100 |
Complies |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
