Description

5-Hydroxy Diclofenac is a key pharmacologically active metabolite of the widely used non-steroidal anti-inflammatory drug (NSAID) Diclofenac. This compound is of significant interest for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of analytical reference standards. It is primarily utilized by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in bioanalytical method development, impurity profiling, and metabolite identification studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and qualification of Diclofenac and its metabolites in biological matrices and drug products.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, efficacy, and safety profile of Diclofenac.
• Impurity Profiling: Used as an identified impurity standard in the quality control of Diclofenac active pharmaceutical ingredient (API) and finished dosage forms to ensure compliance with ICH guidelines.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, or GC-MS methods for therapeutic drug monitoring and pharmacokinetic studies.
• Toxicological Studies: Employed in research to understand the role of specific metabolites in the therapeutic and adverse effects of NSAIDs.

Basic Information

Product Name	5-Hydroxy Diclofenac
CAS No.	69002-84-2
Molecular Formula	C14H11Cl2NO3
Molecular Weight	312.15 g/mol
Synonyms	5-Hydroxydiclofenac; 2-[(2,6-Dichlorophenyl)amino]-5-hydroxybenzeneacetic acid; 5-OH Diclofenac; Diclofenac Hydroxy Metabolite; 5-Hydroxy-2-[(2,6-dichlorophenyl)amino]benzeneacetic acid; 4'-Hydroxy Diclofenac (common alternate numbering); Diclofenac metabolite M1
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Diclofenac is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing including HPLC for purity, IR and MS for structural confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) detailing all test results, ensuring traceability and compliance with research-grade standards. Specifications are designed to meet the rigorous demands of pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Avoid prolonged exposure to air during handling.

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%
Loss on Drying	≤ 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.