Description

Fexofenadinone CAS NO 76811-98-8 is a key pharmaceutical intermediate and a primary metabolite of the widely used antihistamine, fexofenadine. Its significance lies in its critical role in the synthesis and analytical profiling of fexofenadine-based active pharmaceutical ingredients (APIs), ensuring product quality and regulatory compliance. This high-purity compound is essential for manufacturers and research institutions in the pharmaceutical, biotechnology, and analytical chemistry sectors.

Application

• Pharmaceutical Intermediate: Primary use in the synthesis and manufacturing of the antihistamine drug, Fexofenadine HCl.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in API production.
• Metabolite Studies: Used in pharmacokinetic and drug metabolism research to study the biotransformation of fexofenadine.
• Impurity Profiling: Critical for identifying and quantifying related substances in fexofenadine drug substances and finished dosage forms.
• Analytical Chemistry: Employed as a standard in HPLC, LC-MS, and other chromatographic assays for accurate quantification.
• Research & Development: Utilized in medicinal chemistry for the development of new analogs or formulation studies.

Basic Information

Product Name	Fexofenadinone
CAS No.	76811-98-8
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound A; Carboxyterfenadine; Terfenadine Carboxylic Acid; 4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic Acid; (±)-p-[1-Hydroxy-4-[4-(α-hydroxy-α-phenylbenzyl)piperidino]butyl]-α-methylhydratropic Acid; AZ 12354616; Fexofenadine Impurity A; Fexofenadine Metabolite
EINECS	Contact for details

Quality Control

Our Fexofenadinone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets high-grade pharmaceutical standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications suitable for use as a reference standard and intermediate.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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