Description

Fenofibrate Related Compound C (25 Mg) (1-Methylethyl 2-[[2-[4-(4-Chlorobenzoyl)Phenoxy]-2-Methylpropanoyl]Oxy]-2-Methylpropanoate) is a high-purity reference standard and a key process-related impurity in the synthesis of the lipid-regulating drug Fenofibrate. This compound is critical for pharmaceutical research, development, and quality control, enabling precise analytical method validation and impurity profiling. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of impurities in Fenofibrate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, calibrating, and validating chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and system precision check in routine quality control testing of Fenofibrate batches.
• Stability Studies: Employed to track the formation and levels of this specific impurity during drug product stability testing under various ICH conditions.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by agencies like the FDA and EMA.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this related compound.

Basic Information

Product Name	Fenofibrate Related Compound C (25 Mg) (1-Methylethyl 2-[[2-[4-(4-Chlorobenzoyl)Phenoxy]-2-Methylpropanoyl]Oxy]-2-Methylpropanoate)
CAS No.	217636-48-1
Molecular Formula	C26H31ClO6
Molecular Weight	474.98 g/mol
Synonyms	Fenofibrate Impurity C; Fenofibrate Related Substance C; Isopropyl 2-{[2-(4-{[(4-chlorophenyl)carbonyl]phenoxy)-2-methylpropanoyl]oxy}-2-methylpropanoate; 1-Methylethyl 2-{[2-(4-{[(4-chlorophenyl)carbonyl]phenoxy)-2-methylpropanoyl]oxy}-2-methylpropanoate; Fenofibrate Ester Impurity; Propanoic acid, 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-1-oxopropoxy]-2-methyl-, 1-methylethyl ester
EINECS	Contact for details

Quality Control

Our Fenofibrate Related Compound C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by HPLC, IR, and other pharmacopeial methods. We support compliance with ICH Q3A/B guidelines and can provide materials suitable for use in methods validated per USP/EP monographs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.