Description

Bezafibrate Ep Impurity C is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical development of Bezafibrate, a lipid-regulating agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method validation, impurity profiling, and ensuring drug safety.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bezafibrate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for impurity profiles required in ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability testing.
• Research & Development: Utilized in metabolic studies, degradation pathway elucidation, and synthetic chemistry research related to fibrate-class drugs.

Basic Information

Product Name	Bezafibrate Ep Impurity C
CAS No.	2157488-46-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bezafibrate Impurity C; Bezafibrate Related Compound C; Bezafibrate EP Impurity C; 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoic Acid Impurity; Bezafibrate Process Impurity; Bezafibrate Specified Impurity; Fibrate Impurity Standard
EINECS	Contact for details

Quality Control

Our Bezafibrate Ep Impurity C is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is thoroughly characterized and tested using advanced analytical techniques, including HPLC and mass spectrometry, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your needs for reliable reference materials in GMP and research environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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%

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