Description

Fexofenadine Hydrochloride CAS NO 138452-21-8 is a potent, non-sedating antihistamine API (Active Pharmaceutical Ingredient) used to relieve symptoms associated with seasonal allergies and chronic idiopathic urticaria. Its primary value lies in its high selectivity for the H1 receptor and its lack of penetration into the central nervous system, which minimizes drowsiness and other side effects common to older antihistamines. This compound is essential for pharmaceutical manufacturers developing and producing advanced oral antihistamine medications, including tablets, capsules, and oral suspensions.

Application

• Pharmaceutical API: Primary active ingredient in prescription and over-the-counter (OTC) antihistamine medications.
• Tablet Formulation: Used in the manufacture of fast-dissolving, film-coated, and standard compressed tablets.
• Capsule Production: Incorporated into both hard gelatin and softgel capsule formulations.
• Oral Suspensions: Key component in pediatric and adult liquid dosage forms for easier administration.
• Generic Drug Manufacturing: Serves as the core API for bioequivalent generic versions of branded antihistamines.
• Clinical Research: Used as a reference standard and raw material in pharmacological studies and new drug development.

Basic Information

Item	Details
Product Name	Fexofenadine Hydrochloride
CAS No.	138452-21-8
Molecular Formula	C32H39NO4 • HCl
Molecular Weight	538.12 g/mol
Synonyms	Fexofenadine HCl; (±)-Fexofenadine Hydrochloride; 4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid hydrochloride; Allegra (Brand Name); Telfast (Brand Name); MDL 16455A; Carboxyterfenadine Hydrochloride
EINECS	Contact for details

Quality Control

Our Fexofenadine Hydrochloride is manufactured under strict quality systems. We provide material that meets or exceeds relevant pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, and impurities. Certificates of Analysis (COA) documenting all test results are available upon request to ensure full traceability and compliance for your regulatory submissions.

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); the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Optical Rotation	-15.0° to -18.0° (c=1 in methanol)

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