Description

Ciprofibrate Ep Impurity C CAS NO 2469279-29-4 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Ciprofibrate by accurately identifying and quantifying related substances. It is an essential tool for research scientists, analytical chemists, and quality assurance professionals working in pharmaceutical R&D and production. The material is supplied with comprehensive analytical data to support regulatory filings and internal quality systems.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Ciprofibrate Ep Impurity C in drug substances and products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Ciprofibrate API.
• Regulatory Compliance and Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Ciprofibrate.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Ciprofibrate Ep Impurity C
CAS No.	2469279-29-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ciprofibrate Impurity C; Ciprofibrate Related Compound C; Ciprofibrate EP Impurity C; 2-[4-(2,2-Dichlorocyclopropyl)phenoxy]-2-methylpropanoic acid impurity; Ciprofibrate Process Impurity; Ciprofibrate Degradant; Ciprofibrate Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ciprofibrate Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (e.g., EP, USP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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