Description

R-Fexofenadine is the pharmacologically active enantiomer of the widely used non-sedating antihistamine, fexofenadine. This high-purity chiral intermediate is critical for the development and manufacturing of advanced enantiopure pharmaceutical formulations. It is essential for pharmaceutical R&D departments, process chemists, and manufacturers focused on producing next-generation allergy and histamine-mediated disorder treatments with optimized efficacy and safety profiles.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use as a key chiral building block in the commercial production of enantiomerically pure fexofenadine hydrochloride.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material for developing novel enantioselective synthesis routes and new drug formulations.
• Process Chemistry & Optimization: Used in scaling up and optimizing manufacturing processes to improve yield, purity, and cost-efficiency for final API production.
• Analytical Method Development: Acts as a high-purity standard for HPLC, LC-MS, and other analytical techniques to ensure quality control of final drug products.
• Clinical Trial Material Manufacturing: Supplied for the production of batches used in Phase I-III clinical studies for new antihistamine drugs.
• Generic Drug Manufacturing: A vital intermediate for companies producing bioequivalent versions of branded fexofenadine medications.

Basic Information

Product Name	R-Fexofenadine
CAS No.	139965-10-9
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	(R)-Fexofenadine; (+)-Fexofenadine; (R)-(+)-Fexofenadine; Fexofenadine Impurity F (EP); Fexofenadine Related Compound F (USP); (R)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid; Terfenadine Carboxylate Metabolite (R-enantiomer); Allegra® (R)-enantiomer intermediate
EINECS	Contact for details

Quality Control

Our R-Fexofenadine CAS NO 139965-10-9 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral HPLC for enantiomeric excess (ee) verification, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and can be tailored to meet specific pharmacopeial standards (USP, EP, JP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere such as nitrogen or argon.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Enantiomeric Purity (Chiral HPLC)	≥99.0% ee
Related Substances (HPLC)	Total impurities ≤1.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.