Description

Fexofenadine n-Oxide is a key pharmaceutical intermediate and metabolite of the widely used antihistamine, fexofenadine. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily sought by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and quality control of antihistamine medications.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis and process development of fexofenadine and its derivatives.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify fexofenadine metabolites in biological matrices.
• Pharmacokinetic Research: Essential for studying the absorption, distribution, metabolism, and excretion (ADME) profile of fexofenadine.
• Impurity Profiling: Serves as a known impurity or degradation product standard for quality control and stability testing of fexofenadine API and finished dosage forms.
• Drug Discovery & Development: Utilized in preclinical and clinical research to understand the safety and efficacy profile of fexofenadine-related compounds.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary data on drug metabolites and process-related impurities.

Basic Information

Product Name	Fexofenadine n-Oxide
CAS No.	1422515-52-3
Molecular Formula	C32H39NO5
Molecular Weight	517.66 g/mol
Synonyms	Fexofenadine N-Oxide; Fexofenadine N-Oxide (Metabolite); (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid N-Oxide; 2-[4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid N-Oxide; Fexofenadine Metabolite; Allegra Metabolite; MDL 16455A N-Oxide
EINECS	Contact for details

Quality Control

Our Fexofenadine n-Oxide is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure it meets stringent specifications for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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