Description

Diclofenac Impurity 16 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the non-steroidal anti-inflammatory drug (NSAID) Diclofenac. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety, efficacy, and regulatory compliance. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry involved in method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Diclofenac sodium or potassium drug substances and finished products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Serves as a system suitability and identification standard in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency.
• Stability Studies: Employed to identify and track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate understanding and control of the drug's impurity profile.
• Pharmacopoeial Testing: Supports testing procedures aligned with monographs from USP, EP, BP, or other international pharmacopoeias.

Basic Information

Product Name	Diclofenac Impurity 16
CAS No.	127792-34-1
Molecular Formula	C14H11Cl2NO2
Molecular Weight	296.15 g/mol
Synonyms	1-(2,6-Dichlorophenyl)-2-indolinone; 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid lactam; Diclofenac Lactam; Diclofenac EP Impurity G; Diclofenac USP Impurity G; Diclofenac Related Compound G; 2-[(2,6-Dichlorophenyl)amino]phenylacetic acid, γ-lactam
EINECS	Contact for details

Quality Control

Every batch of Diclofenac Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated chromatographic (HPLC/UPLC) and spectroscopic (IR, NMR, MS) methods to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5% w/w

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