Description

Clinofibrate Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Clinofibrate through rigorous impurity profiling and method validation. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of this well-characterized impurity standard is fundamental for meeting stringent pharmacopeial and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Clinofibrate API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate stability-indicating assay methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability test component and a quantitative standard for routine batch release testing in GMP environments.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding and control of the impurity profile.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Clinofibrate.

Basic Information

Product Name	Clinofibrate Impurity
CAS No.	30299-29-7
Molecular Formula	C17H16Cl2O4
Molecular Weight	355.22 g/mol
Synonyms	2-(4'-(2,2-Dichlorocyclopropyl)phenoxy)-2-methylpropanoic Acid; 2-Methyl-2-[4-[(1R,2S)-2,2-dichlorocyclopropyl]phenoxy]propanoic Acid; Clinofibrate Related Compound; Clinofibrate Degradant; Clinofibrate Process Impurity; Lipoclin Impurity; S-8520 Impurity
EINECS	Contact for details

Quality Control

Every batch of Clinofibrate Impurity CAS 30299-29-7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling 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, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

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: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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