Description

Fexofenadine Imp-2 is a high-purity chemical reference standard, specifically identified as an impurity of the antihistamine drug Fexofenadine. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and fine chemical industries for method validation, impurity profiling, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Fexofenadine API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Fexofenadine to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Fexofenadine Imp-2
CAS No.	862777-10-4
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound B; Fexofenadine Impurity B; 4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid; Fexofenadine EP Impurity B; Fexofenadine USP Related Compound B; Fexofenadine Acid Impurity; (RS)-Fexofenadine Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Imp-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques like HPLC, NMR, and Mass Spectrometry. We support compliance with ICH Q3A/B, USP, and EP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain 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 ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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