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Fexofenadine hydrochloride (CAS No 153439-40-8), one of the active ingredients of ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride.
It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.
Specification
Items Specification
Appearance White or almost white crystalline powder
Water Not more than 2.0%
Residue on ignition Not more than 0.1%
Heavy metals Not more than 20ppm
Unspecified impurities Not more than 0.1%
Total impurities Not more than 0.5%
Organic volatile impurities
Methanol NMT 0.3%
Ethanol NMT0.5%
Acetone NMT 0.5%
Ethyl acetate NMT 0.5%
Methyl isobutyl ketone NMT 0.5%
Content of Chloride 6.45% to 6.75%
Assay(on the dried basis) 98.0% to 102.0%
Application
For a variety of allergic diseases. Used for allergic rhinitis, allergic conjunctivitis, chronic urticaria and other allergic symptoms.
Packing&Storage
25 kg/drum.
Stored in dry and ventilation place, far from heat and water.
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