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Key Documents

1270377

USP

Fexofenadine hydrochloride

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Fexofenidine hydrochloride, MDL 16455 hydrochloride, Terfenidine carboxylate hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C32H39NO4 · HCl
CAS Number:
Molecular Weight:
538.12
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

fexofenadine

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

SMILES string

Cl[H].CC(C)(C(O)=O)c1ccc(cc1)C(O)CCCN2CCC(CC2)C(O)(c3ccccc3)c4ccccc4

InChI

1S/C32H39NO4.ClH/c1-31(2,30(35)36)25-17-15-24(16-18-25)29(34)14-9-21-33-22-19-28(20-23-33)32(37,26-10-5-3-6-11-26)27-12-7-4-8-13-27;/h3-8,10-13,15-18,28-29,34,37H,9,14,19-23H2,1-2H3,(H,35,36);1H

InChI key

RRJFVPUCXDGFJB-UHFFFAOYSA-N

Gene Information

human ... HRH1(3269)

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Fexofenadine hydrochloride USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets
  • Fexofenadine Hydrochloride Capsules
  • Fexofenadine Hydrochloride Tablets

Biochem/physiol Actions

Fexofenadine is a non-sedating H1 histamine receptor antagonist.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Erik Sjögren et al.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 57, 214-223 (2013-10-01)
The pharmacokinetics (PK) of fexofenadine (FEX) in pigs were investigated with the focus on exploring the interplay between hepatic transport and metabolism when administered intravenously (iv) alone or with verapamil. The in vivo pig model enabled simultaneous sampling from plasma
Shigeru Hishinuma et al.
Biochemical pharmacology, 91(2), 231-241 (2014-07-30)
Differential binding sites for first- and second-generation antihistamines were indicated on the basis of the crystal structure of human histamine H1 receptors. In this study, we evaluated differences between the thermodynamic driving forces of first- and second-generation antihistamines for human
Takayo Haruna et al.
Pharmacology, 95(1-2), 95-103 (2015-02-28)
We have previously reported that S-777469 [1-([6-ethyl-1-(4-fluorobenzyl)-5-methyl-2-oxo-1,2-dihydropyridine-3-carbonyl]amino)-cyclohexanecarboxylic acid], a novel cannabinoid type 2 receptor (CB2) agonist, significantly suppressed compound 48/80-induced scratching behavior in mice in a dose-dependent manner when it was administered orally. Here, we demonstrated that the inhibitory effects
Jung Yeon Kim et al.
Biomedical chromatography : BMC, 29(3), 465-474 (2014-08-01)
The purpose of this study was to develop and validate an ultra-performance liquid chromatography method for simultaneous analysis of 20 antihistamines (illegal additives) in dietary supplements. The limits of detection and quantitation of the method ranged from 1.5 to 2.5
Ayahisa Watanabe et al.
Journal of pharmaceutical sciences, 104(3), 955-961 (2014-12-03)
In pharmacokinetic evaluation of mice, using serial sampling methods rather than a terminal blood sampling method could reduce the number of animals needed and lead to more reliable data by excluding individual differences. In addition, using serial sampling methods can

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