Description

Diclofenac Related Compound 1 is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound serves as a critical impurity marker for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Diclofenac. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing. The availability of this well-characterized standard is fundamental to maintaining stringent quality standards in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor specific impurities in Diclofenac sodium or potassium API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods in compliance with ICH guidelines.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to ensure Diclofenac drug substances and finished products meet pharmacopeial specifications (USP, EP, BP).
• Stability Studies and Forced Degradation: Acts as a marker compound in stability-indicating assays to track impurity formation under various stress conditions (heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and impurity levels.
• Research and Development (R&D): Utilized in pharmaceutical R&D to study degradation pathways and to synthesize and characterize other related substances.

Basic Information

Item	Detail
Product Name	Diclofenac Related Compound 1
CAS No.	928343-25-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diclofenac Impurity 1; Diclofenac Related Substance 1; [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic acid related compound; Diclofenac EP Impurity A; Diclofenac USP Related Compound; 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one (Proposed structure); Diclofenac Degradation Product
EINECS	Contact for details

Quality Control

Our Diclofenac Related Compound 1 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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