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Synonyms: 4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one hydrogen fumarate
Formula: C19H19NOS.C4H4O4
Molecular weight: 425.50
CAS number: 34580-14-8
Appearance: White to brownish-yellow,fine,crystalline powder
Solubility: Sparingly soluble in water,slightly soluble in
methanol,very slightly soluble in acetonitrile
Clarity and color of solution: Clear and NMT Y4,BY4,B4
Related substances (HPLC)
Impurity A: NMT 0.2%
Impurity B-G: NMT 0.2%
Single unknown impurity: NMT 0.1%
Total impurities: NMT 0.5%
Loss on drying: NMT 0.5%
Sulphated ash: NMT 0.1%
PH: 3.0 ~ 4.0
Heavy metals: NMT 20ppm
Chloride: NMT 0.015%
Assay (potentiometric titration): 98.5% ~ 101.0%
Usage:
Ketotifen fumarate is a second-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt of fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks. Side effects include drowsiness, weight gain, dry mouth, irritability, and increased nosebleeds.
Shelf life: 4 years store in a tightly closed container, protected from light
package:1kg/tin,5kg/carton
