Description

Fexofenadine Hydrochloride is a potent, non-sedating antihistamine API (Active Pharmaceutical Ingredient) widely recognized for its efficacy and safety profile. This compound is critical for the formulation of modern allergy relief medications, offering targeted histamine H1-receptor antagonism without crossing the blood-brain barrier. It is an essential raw material for pharmaceutical manufacturers producing prescription and over-the-counter (OTC) allergy, hay fever, and chronic idiopathic urticaria treatments.

Application

• Pharmaceutical API: Primary active ingredient in prescription and OTC antihistamine tablets, capsules, and oral suspensions.
• Allergy Medication: Formulation of drugs for seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis.
• Antihistamine Production: Manufacture of medications for the relief of symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes.
• Chronic Urticaria Treatment: Key component in drugs used to manage skin conditions like chronic idiopathic urticaria (hives).
• Pediatric Formulations: Used in developing age-appropriate dosage forms for children.
• Generic Drug Manufacturing: Sourcing for cost-effective generic versions of branded antihistamine products.
• Clinical Research: Serves as a reference standard and raw material in pharmacological studies and new drug development.

Basic Information

Product Name	Fexofenadine Hydrochloride
CAS No.	153439-40-8
Molecular Formula	C32H39NO4 • HCl
Molecular Weight	538.12 g/mol
Synonyms	Fexofenadine HCl; (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid hydrochloride; Terfenadine carboxylate metabolite; MDL 16455A; Allegra (brand name active ingredient); Telfast (brand name active ingredient); Fexofen
EINECS	Contact for details

Quality Control

Our Fexofenadine Hydrochloride is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) documenting compliance with in-house specifications are available for every shipment. While not currently certified to a specific pharmacopeia, our quality systems are designed to meet the general principles of GMP (Good Manufacturing Practice) and can support development towards USP/EP/BP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Particle Size	Contact for details

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