Description

Diclofenac Impurity 9 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Diclofenac. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control testing. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Diclofenac-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Diclofenac sodium and related drug substances.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Stability Indicating Method: Employed in forced degradation studies to understand the degradation pathways and stability of Diclofenac formulations.
• Quality Control & Assurance: A vital component in the routine QC testing of active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., ANDA, NDA) by providing necessary impurity characterization data.
• Research and Development: Used in synthetic chemistry and pharmacology research to study the metabolism and impurity formation of Diclofenac.

Basic Information

Product Name	Diclofenac Impurity 9
CAS No.	95093-56-4
Molecular Formula	C14H11Cl2NO2
Molecular Weight	296.15 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzaldehyde; Diclofenac Aldehyde Impurity; Diclofenac Related Compound A (in some contexts); 2-[(2,6-Dichlorophenyl)amino]benzaldehyde; Benzaldehyde, 2-[(2,6-dichlorophenyl)amino]-; Diclofenac Impurity A; Diclofenac Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Diclofenac Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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