Description

Fexofenadine is a potent, non-sedating, second-generation antihistamine widely recognized for its selective peripheral H1-receptor antagonism. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of modern allergy and urticaria treatments. It is primarily required by pharmaceutical manufacturers for the formulation of oral solid dosage forms such as tablets and capsules, as well as for research and development in immunology and respiratory therapeutics.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) antihistamine medications for allergic rhinitis and chronic idiopathic urticaria.
• Tablet Formulation: Direct compression or granulation processes to manufacture fast-dissolving, film-coated, or standard release tablets.
• Capsule Filling: Used in the production of hard gelatin or vegetarian capsules, often in combination with other excipients.
• Pediatric Suspensions: Micronized grades are suitable for developing stable oral suspensions for pediatric use.
• Clinical Research: Serves as a reference standard and raw material in bioequivalence studies and new drug development projects.
• Veterinary Pharmaceuticals: Applied in formulations for managing allergic conditions in companion animals.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for generic drug production.
• Analytical Testing: Used as a high-purity standard in quality control laboratories for HPLC and spectroscopic assays.

Basic Information

Product Name	Fexofenadine
CAS No.	83799-24-0
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Hydrochloride (common salt form); (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid; MDL 16455A; Allegra (Trade Name); Telfast; Fexofenadin; Terfenadine Carboxylate
EINECS	Contact for details

Quality Control

Our Fexofenadine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) are provided, detailing parameters such as assay, related substances, residual solvents, and heavy metals, in compliance with ICH guidelines and relevant pharmacopoeial standards (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

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 Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Specific Rotation	Contact for details

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