Description

Fexofenadine Impurity 12 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, quality control (QC) laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in fexofenadine API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed to track the formation and growth of this impurity under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and justify specifications.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and develop purer synthesis routes for fexofenadine.

Basic Information

Item	Detail
Product Name	Fexofenadine Impurity 12
CAS No.	1010812-98-2
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Fexofenadine Related Compound; Fexofenadine Impurity; 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylbenzeneacetic acid; Fexofenadine Analog; Fexofenadine Process Impurity; Allegra Impurity; Telfast Impurity
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. Comprehensive analytical data, including HPLC chromatograms and spectroscopic evidence (NMR, MS), are documented. A Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.