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Fexofenadine Hydrochloride or Fexofenadine HCl USP BP Ph Eur EP JP Grade Supplier Exporter Manufacturers' Representative |
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Fexofenadine Hydrochloride or Fexofenadine HCl
CAS Number: 138452-21-8 or 153439-40-8
Molecular Formula: C32H39NO4-HCl
Molecular Weight: 538.12
Fexofenadine Hydrochloride or Fexofenadine HCl
Fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine.
Fexofenadine Hydrochloride USP Grade Specifications:
C32H39NO4-HCl --- 538.12
Benzeneacetic acid, 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, hydrochloride, (±)-;
(±)-p-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidino]butyl]-α-methylhydratropic acid, hydrochloride 138452-21-8
UNII: 2S068B75ZU
DEFINITION
Fexofenadine Hydrochloride contains NLT 98.0% and NMT 102.0% of fexofenadine hydrochloride (C32H39NO4-HCl), calculated on the anhydrous basis.
IDENTIFICATION
A. Infrared Absorption
B. The retention time of the fexofenadine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Examine the precipitate formed in Other Components for the Content of Chloride test.
Acceptance criteria: A white precipitate is observed.
Content of Chloride: 6.45%–6.75% on the anhydrous basis.
Residue on Ignition: NMT 0.1%
Limit of Fexofenadine Related Compound B: To pass the test by chromatography.
Other Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 2.0% for the anhydrous form; 6.0%–10.0% for the hydrate form. [Note— “Hydrate” refers to a mixture of dihydrate and trihydrate forms of fexofenadine hydrochloride.]
Packaging and Storage: Preserve in well-closed, light-resistant containers, and store at controlled room temperature.
Fexofenadine Hydrochloride is also available in EP BP Ph Eur JP monograph.
Please visit SDS Safety Data Sheet of Fexofenadine Hydrochloride or Fexofenadine HCl Suppliers.
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