Ketotifen fumarate.jpg
Ketotifen is a first-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis. In its oral form, it is used to prevent asthma attacks or Anaphylaxis, as well as various mast cell, allergic-type disorders.
Uses
Ketotifen relieves and prevents eye itchiness and/or irritation associated with most seasonal allergies. It starts working within minutes after administering the drops. The drug has not been studied in children under three.
[Specifications] 
Appearance
White or brownish-yellow, fine, crystalline powder
brownish-yellow
crystalline powder
Solubility
Sparingly solube in water ,slight solube in methanol , very slightly solube in acetonitrile
Conforms
 Identification
A.The IR spectrum is concordant with the Ph.Eur.reference spectrum of Ketotifen fumarate .
Conforms
B.The spot due to fuaric acid in the chromatogram obtained with the test solution is similar in position ,color and intensity to the principal spot in the chromatogram obtained with the reference solution
Conforms
Appearance of solution
The solution is clear and not more intensely coloured than reference solution Y4,BY4,or B4
Conforms
Related substances (HPLC)
Impurity G:NMT 0.2%
0.11%
Unspecified impurity :NMT 0.10%
<Disregard limit 0.05%
Total impurities: NMT 0.5%
0.30%
Loss on drying
NMT 0.5%
0.3%
Sulphated ash
NMT 0.1%
0.04
Residual solvens(GC)
Methanol: NMT 3000 ppm
None detected
Ethanol: NMT 5000 ppm
None detected
Acetone: NMT 5000 ppm
2741 ppm
Tetrahydrofuran: NMT 720 ppm
None detected
Assay
NLT 98.5%& NMT101.0%(dried substance)
99.4%

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Notice: This product is only suitable for laboratory use, or the use of animals. It can not be used directly on the human body

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