Description

Fexofenadine Ep Impurity F CAS NO 185066-33-5 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fexofenadine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fexofenadine API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure impurity levels meet pharmacopeial specifications (e.g., USP, EP, ICH).
• Stability Studies: Employed to monitor the formation of degradation products in Fexofenadine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purer synthesis routes for Fexofenadine.

Basic Information

Product Name	Fexofenadine Ep Impurity F
CAS No.	185066-33-5
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound F; Fexofenadine Impurity F; (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid; Terfenadine Carboxylic Acid Metabolize Impurity; Allegra Impurity F; MDL 16455A Impurity
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Ep Impurity F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard production. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC assay, related substances, residual solvents, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH Q3A, Q3B, USP, and European Pharmacopoeia guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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