Description

Diclofenac Related Compound CAS NO 172494-87-0 is a high-purity chemical reference standard, critical for ensuring the quality and safety of pharmaceutical products. This compound serves as a key impurity marker and analytical standard in the development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Diclofenac. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on impurity profiling, method validation, and compliance testing.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Diclofenac sodium and potassium drug substances and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and mass spectrometry methods in QC laboratories.
• Pharmacopoeial Compliance: Supports testing to meet stringent purity criteria outlined in international pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances in Diclofenac formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate control over product quality.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Diclofenac Related Compound
CAS No.	172494-87-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diclofenac Impurity; Diclofenac Related Substance; 1-(2,6-Dichlorophenyl)indolin-2-one (likely structure); Diclofenac Degradation Product; Diclofenac Process Impurity; Diclofenac EP Impurity; Diclofenac USP Related Compound; [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic acid derivative
EINECS	Contact for details

Quality Control

Every batch of our Diclofenac Related Compound is manufactured and analyzed under strict quality management systems. The product is characterized and qualified using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality standards align with the requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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