Description

Fexofenadine Impurity 1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) fexofenadine hydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in pharmaceutical production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in fexofenadine API and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for impurity profiling and characterization studies to meet ICH Q3A(R2) and Q3B(R2) regulatory guidelines.
• Used in stability studies to monitor impurity levels in fexofenadine formulations under various storage conditions.
• Serves as a key material in pharmaceutical research and development for process optimization and impurity synthesis.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity data for drug master files.

Basic Information

Product Name	Fexofenadine Impurity 1
CAS No.	252022-32-5
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound 1; Fexofenadine EP Impurity 1; Fexofenadine USP Impurity 1; α,α-Dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-benzeneacetic acid; 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylbenzeneacetic acid; Fexofenadine Acid Impurity; Fexofenadine Carboxylic Acid Impurity; Terfenadine Carboxylate
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability conform to pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic nature, the container must be kept tightly sealed after each use to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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