Description

Bezafibrate Impurity D is a specified impurity and degradation product of the pharmaceutical active ingredient Bezafibrate. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Bezafibrate-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bezafibrate drug substances and finished products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing of raw materials and finished pharmaceutical formulations containing Bezafibrate.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Bezafibrate.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research and Development: Used in R&D to understand the degradation pathways and chemical behavior of the Bezafibrate molecule.

Basic Information

Product Name	Bezafibrate Impurity D
CAS No.	41859-58-9
Molecular Formula	C19H20ClNO4
Molecular Weight	361.82 g/mol
Synonyms	2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoic Acid; Bezafibrate Impurity 4; Bezafibrate Related Compound D; Bezafibrate EP Impurity D; 4'-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxyisobutyric Acid; Bezafibrate Acid Impurity; Bezafibrate Free Acid
EINECS	Contact for details

Quality Control

Our Bezafibrate Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for every batch to support your regulatory and quality assurance needs.

Storage

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

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)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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