Description

Diclofenac Dimer Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of dimeric impurities during the analysis and manufacturing of the active pharmaceutical ingredient (API) Diclofenac. It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical industry to ensure product safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of dimer-related impurities in Diclofenac sodium or potassium API batches.
• Analytical Method Development and Validation: Used as a critical system suitability component in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits.
• Quality Control & Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure the stability of Diclofenac formulations over time.
• Regulatory Compliance & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Diclofenac Dimer Impurity
CAS No.	1609187-30-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diclofenac Dimer; Diclofenac Impurity Dimer; Bis(2-((2,6-dichlorophenyl)amino)phenyl)acetic Acid Dimer; Diclofenac Related Compound Dimer; Dimeric Impurity of Diclofenac; Diclofenac Dimer Related Substance
EINECS	Contact for details

Quality Control

Every batch of Diclofenac Dimer Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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