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Key Documents

PHR1685

Supelco

Fexofenadine HCl

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Fexofenadine hydrochloride, Fexofenidine hydrochloride, MDL 16455 hydrochloride, Terfenidine carboxylate hydrochloride

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About This Item

Fórmula empírica (Notação de Hill):
C32H39NO4 · HCl
Número CAS:
Peso molecular:
538.12
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

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

família API

fexofenadine

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

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

chave InChI

RRJFVPUCXDGFJB-UHFFFAOYSA-N

Informações sobre genes

human ... HRH1(3269)

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Descrição geral

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.

Aplicação

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.

Ações bioquímicas/fisiológicas

Fexofenadine is a non-sedating H1 histamine receptor antagonist.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

produto relacionado

Nº do produto
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Preços

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°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)
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)
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)

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