Ketotifen fumarate

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