Description

Fexofenadine Impurity 5 (CAS 1347311-10-7) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the manufacture of the active pharmaceutical ingredient (API) fexofenadine hydrochloride. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of fexofenadine API and finished drug products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control and Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity levels.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and growth of specific impurities under various stress conditions during drug stability testing.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Fexofenadine Impurity 5
CAS No.	1347311-10-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fexofenadine Related Compound 5; Fexofenadine Hydrochloride Impurity 5; Fexofenadine Process Impurity; 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylbenzeneacetic acid impurity; Allegra Impurity 5; Telfast Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 in a desiccated environment to maintain stability and purity. Avoid exposure to excessive heat and humidity.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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