Description

Choline Fenofibrate Impurity 1 is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient, Fenofibrate. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on cardiovascular and lipid-regulating therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fenofibrate and Choline Fenofibrate drug substances and finished products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) protocols.
• Stability Studies: Used to monitor the formation of degradation products in Fenofibrate-based formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity profiling data required for drug master files (DMFs) and marketing authorization applications.
• Quality Control Testing: Enables in-process control and batch release testing in pharmaceutical manufacturing to ensure impurity levels remain within specified safety limits.
• Research and Development: Aids in the study of drug metabolism, pharmacokinetics, and the chemical pathways of impurity formation during synthesis.

Basic Information

Product Name	Choline Fenofibrate Impurity 1
CAS No.	2985-79-7
Molecular Formula	C22H28ClNO4
Molecular Weight	405.92 g/mol
Synonyms	Fenofibrate Impurity F; Fenofibrate Related Compound F; 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid choline salt; Choline (2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate); Choline salt of Fenofibric acid; (2-Hydroxyethyl)trimethylammonium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate; ABT-335 Impurity; Trilipix Impurity
EINECS	Contact for details

Quality Control

Every batch of Choline Fenofibrate Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere conditions when opening to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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