Description

Clinofibrate Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug substance Clinofibrate. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification in the analysis of Clinofibrate drug substance and finished products.
• Method Development and Validation for HPLC, GC, or LC-MS assays to quantify related substances.
• Stability Studies as a marker compound to monitor degradation pathways of Clinofibrate.
• Quality Control (QC) and Quality Assurance (QA) as a certified reference material for routine batch testing.
• Regulatory Submissions to support drug master files (DMFs) and new drug applications (NDAs/ANDAs).
• Academic and Industrial Research into the metabolism, pharmacokinetics, and synthesis pathways of fibrate-class drugs.

Basic Information

Product Name	Clinofibrate Impurity
CAS No.	30299-17-3
Molecular Formula	C17H16Cl2O4
Molecular Weight	355.22 g/mol
Synonyms	2-(4'-(p-Chlorophenoxy)phenoxy)-2-methylpropanoic Acid; 2-Methyl-2-[4-(4-chlorophenoxy)phenoxy]propanoic Acid; Clinofibrate Related Compound; Propanoic acid, 2-methyl-2-[4-(4-chlorophenoxy)phenoxy]-; Lipoclin Impurity
EINECS	Contact for details

Quality Control

Every batch of Clinofibrate Impurity CAS NO 30299-17-3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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