Description

Diclofenac Related Compound 7 is a high-purity analytical reference standard, specifically identified as a key impurity and degradation product 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 and efficacy. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical industry for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Diclofenac sodium and related drug substances and products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products in Diclofenac formulations.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure batches of Diclofenac API and finished dosage forms meet stringent purity specifications.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Pharmacopoeial Testing: Used in testing to comply with monograph standards set by USP, EP, BP, and other pharmacopoeias.

Basic Information

Item	Details
Product Name	Diclofenac Related Compound 7
CAS No.	146607-19-4
Molecular Formula	C14H10Cl2N2O2
Molecular Weight	309.15 g/mol
Synonyms	1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one; Diclofenac Impurity 7; Diclofenac EP Impurity C; Diclofenac Related Substance C; 2,6-Dichloro-N-(2-oxo-2,3-dihydro-1H-indol-1-yl)aniline; Diclofenac Degradation Product; Diclofenac Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Diclofenac Related Compound 7 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference standards. A comprehensive Certificate of Analysis (CoA) is provided with each lot, detailing all test results and traceability. Our quality commitment aligns with the principles of GMP and ISO 17034 (Reference Material Producer) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
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.