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Fexofenadine Manufacturing Thailand, the United Kingdom and USA
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Fexofenadine

  • Product Name : Fexofenadine
  • Grade : IP / BP / USP
  • Therapeutic Category : Antihistamine
  • CAS No : 83799-24-0
  • COA : Available
  • MSDS : Available

Description

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.

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