Description

Ciprofibrate Impurity D CAS NO 130232-51-8 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critically important for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Ciprofibrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ciprofibrate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods in QC laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in Ciprofibrate products under various stability conditions.
• Quality Control & Batch Release: Used in routine QC testing to ensure that Ciprofibrate batches meet stringent pharmacopeial (e.g., USP, EP) or in-house purity specifications.
• Research & Development: Utilized in pharmaceutical R&D for studying the metabolism, synthesis pathways, and degradation mechanisms of Ciprofibrate.

Basic Information

Product Name	Ciprofibrate Impurity D
CAS No.	130232-51-8
Molecular Formula	C13H9Cl2FO2
Molecular Weight	287.11 g/mol
Synonyms	2-[4-(2,2-Dichlorocyclopropyl)phenoxy]-2-methylpropanoic Acid; Ciprofibrate Related Compound D; Ciprofibrate EP Impurity D; Ciprofibrate USP Impurity D; Ciprol; 1-Methylethyl 2-[4-(2,2-dichlorocyclopropyl)phenoxy]-2-methylpropanoate Impurity; Lipanor Impurity D
EINECS	Contact for details

Quality Control

Our Ciprofibrate Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if prolonged exposure is anticipated.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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