Description

Ciprofibrate Impurity A CAS NO 1474058-89-3 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) Ciprofibrate by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and drug substance characterization.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ciprofibrate Impurity A in drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor impurities in Ciprofibrate API.
• Quality Control & Assurance: Employed in routine QC testing to ensure Ciprofibrate batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Ciprofibrate formulations.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Serves as a tool in research to study the synthesis, metabolism, and degradation pathways of Ciprofibrate.

Basic Information

Product Name	Ciprofibrate Impurity A
CAS No.	1474058-89-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-[4-(2,2-Dichlorocyclopropyl)phenoxy]-2-methylpropanoic acid (Ciprofibrate Impurity A); Ciprofibrate Related Compound A; Ciprofibrate EP Impurity A; Ciprofibrate USP Impurity A; Ciprofibrate Process Impurity; Ciprofibrate Degradant; Ciprofibrate Analog
EINECS	Contact for details

Quality Control

Our Ciprofibrate Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	95.0% - 105.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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