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PHR1685

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Fexofenadine HCl

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Fexofenadine hydrochloride, Fexofenidine hydrochloride, MDL 16455 hydrochloride, Terfenidine carboxylate hydrochloride
Empirical Formula (Hill Notation):
C32H39NO4 · HCl
CAS Number:
Molecular Weight:
538.12
MDL number:
PubChem Substance ID:

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 1095
traceable to Ph. Eur. Y0000789
traceable to USP 1270377

API family

fexofenadine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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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This Item
Y0000789BP1095BP1096
Fexofenadine HCl Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1685

Fexofenadine HCl

Fexofenadine hydrochloride European Pharmacopoeia (EP) Reference Standard

Y0000789

Fexofenadine hydrochloride

Fexofenadine hydrochloride British Pharmacopoeia (BP) Reference Standard

BP1095

Fexofenadine hydrochloride

Fexofenadine impurity standard British Pharmacopoeia (BP) Reference Standard

BP1096

Fexofenadine impurity standard

packaging

pkg of 1 g

packaging

-

packaging

-

packaging

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical

application(s)

pharmaceutical

format

neat

format

neat

format

neat

format

mixture

storage temp.

2-30°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

General description

Fexofenadine HCl belongs to the class of drugs known as antihistamines. It acts by selective blockade of H1-receptors and is generally used in the treatment of seasonal allergic rhinitis.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Fexofenadine HCl may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulation by spectrophotometry and high performance liquid chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Fexofenadine is a non-sedating H1 histamine receptor antagonist.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB9160 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

related product

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms
Karakus S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 46(2), 295-302 (2008)
Fexofenadine Hydrochloride
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 34(3)(1), 1828-1828 (2019)
RP-HPLC method for the quantitative determination of fexofenadine hydrochloride in coated tablets and human serum
Arayne MS, et al.
Medicinal Chemistry Research, 20(1), 55-61 (2011)
Fexofenadine HCl is safe and effective for treatment of chronic idiopathic urticaria
Harold SN, et al.
Annals of Allergy, Asthma & Immunology, 84(5), 517-522 (2000)
Spectrophotometric and high performance liquid chromatographic determination of fexofenadine hydrochloride in pharmaceutical formulations
Kozan I, et al
Turkish Journal of Pharmaceutical Sciences, 5(3), 175-189 (2008)

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