Description

Diclofenac Impurity P is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Diclofenac Sodium. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Diclofenac Sodium API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Diclofenac formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Diclofenac.
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant for routine batch release testing in QC labs.

Basic Information

Product Name	Diclofenac Impurity P
CAS No.	1609187-32-7
Molecular Formula	C14H10Cl2NNaO2
Molecular Weight	318.13 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt impurity; Diclofenac EP Impurity P; Diclofenac Sodium Impurity P; Sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate related compound P; 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one sodium salt (common misassignment, verify structure); Diclofenac Related Compound P
EINECS	Contact for details

Quality Control

Our Diclofenac Impurity P is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

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)	Total impurities ≤ 2.0% Any individual unknown 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.