Description

Diclofenac Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Diclofenac sodium, a widely used non-steroidal anti-inflammatory drug (NSAID). It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions for method development, validation, and regulatory compliance. The availability of this well-characterized impurity is essential for accurate identification and quantification during the drug development and manufacturing process.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Diclofenac sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for routine batch testing to ensure drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Submission: Essential for preparing drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over potential impurities.
• Stability Studies: Used to monitor the formation of degradation products in Diclofenac formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Supports studies on the metabolic pathways, degradation mechanisms, and toxicological profile of Diclofenac and its related substances.

Basic Information

Product Name	Diclofenac Impurity 7
CAS No.	857759-90-1
Molecular Formula	C14H10Cl2NNaO2
Molecular Weight	318.13 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt impurity; Diclofenac Sodium Impurity 7; Diclofenac EP Impurity G; Diclofenac Related Compound 7; Sodium 2-[2-(2,6-dichlorophenyl)amino]phenylacetate; Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, sodium salt (1:1); Diclofenac Sodium Degradant
EINECS	Contact for details

Quality Control

Our Diclofenac Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. The material is suitable for use as a reference standard in compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. Keep away from heat and incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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