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Fexofenadine hydrochloride

Fexofenadine hydrochloride

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PRODUCT NAME: Fexofenadine hydrochloride
CAS NUMBER: 153439-40-8

MP 148-150°C
storage temp.
-20°C Freezer
Biological Activity Selective histamine H 1 receptor antagonist (pK i = 8.1). Active metabolite of terfenadine that displays non-sedating antiallergic effects.
Usage The active metabolite of Terfenadine (T114500), a H1-histamine receptor antagonist.
Analysis Test Specification Result
Description White to off-white powder or crystalline powder; bitter taste, odorless White crystalline powder
chloride The solution gives reaction of chloride complies
HPLC The retention time of the main peak of the test solution corresponds to that of reference peak complies
IR The infrared spectrum of the testing solution corresponds to that of reference solution complies
Residual on ignition ≤0.1% max 0.06%
Heavy metals Not more than 0.2% complies
Impurity B Not more than 0.2% Not detected
Water Not more than 0.5% 0.34%
Impurity A Not more than 0.2% 0.03%
decarboxylated degradant Not more than 0.15% 0.05%
Single impurity Not more than 0.1% 0.06%
Total impurities Not more than 0.5% 0.2%
Content of chloride 6.45%~6.75% 6.52%
Assay(Calculated on the anhydrous basis) Not less than 98.0% and Not more than 102.0% 99.6%
Conclusion meet the USP Standard

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