PHR1685

Fexofenadine HCl

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Fexofenadine hydrochloride, Fexofenidine hydrochloride, MDL 16455 hydrochloride, Terfenidine carboxylate hydrochloride
• Empirical Formula (Hill Notation): C₃₂H₃₉NO₄ · HCl
• CAS Number: 153439-40-8
• Molecular Weight: 538.12
• NACRES: NA.24
• PubChem Substance ID: 329823555
• UNSPSC Code: 41116107
• MDL number: MFCD00865710

Properties

• 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
• SMILES string: Cl[H].CC(C)(C(O)=O)c1ccc(cc1)C(O)CCCN2CCC(CC2)C(O)(c3ccccc3)c4ccccc4
• InChI key: RRJFVPUCXDGFJB-UHFFFAOYSA-N
• grade: certified reference material, pharmaceutical secondary standard
• agency: 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
• Quality Level: 300
• Gene Information: human ... HRH1(3269)

Description

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.[1]
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[2] and high performance liquid chromatography.[2][3][4][5]

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 and EP 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.

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.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable