Description

Fexofenadine Impurity 14 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) fexofenadine hydrochloride. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and routine impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the analysis of fexofenadine API and its formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to meet ICH guidelines.
• Quality Control and Release Testing: Employed in the routine QC testing of fexofenadine batches to ensure impurity levels remain within specified limits as per pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions (thermal, photolytic, hydrolytic) as part of drug stability programs.
• Regulatory Submissions: Essential for preparing impurity data packages required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research and Development: Utilized in synthetic chemistry R&D to understand and control the formation pathways of this impurity during the API manufacturing process.

Basic Information

Product Name	Fexofenadine Impurity 14
CAS No.	908595-88-0
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound 14; Fexofenadine EP Impurity 14; Fexofenadine USP Impurity 14; 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylbenzeneacetic acid; (4-(4-(4-(Hydroxy(diphenyl)methyl)piperidin-1-yl)-1-hydroxybutyl)-α,α-dimethylphenyl)acetic acid; Allegra Impurity 14; Telfast Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Impurity 14 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity screening using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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