Description

4Hydroxy Diclofenac-D4 (Major) is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This stable isotope-labeled compound is essential for ensuring precision and reliability in mass spectrometry-based assays, particularly for minimizing matrix effects and correcting for analyte loss. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in drug metabolism and bioequivalence studies for the non-steroidal anti-inflammatory drug (NSAID) diclofenac.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of diclofenac and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic & Bioanalytical Research: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies.
• Drug Metabolism Studies: Used to investigate the metabolic pathways and profile of hydroxylated diclofenac metabolites.
• Bioequivalence Testing: Provides the analytical rigor required for regulatory submissions comparing generic and branded diclofenac formulations.
• Forensic & Doping Control Analysis: Supports the accurate detection and quantification of diclofenac in forensic toxicology and anti-doping programs.
• Method Development & Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with GLP and ICH guidelines.

Basic Information

Product Name	4Hydroxy Diclofenac-D4 (Major)
CAS No.	254762-27-1
Molecular Formula	C14H7D4Cl2NO3
Molecular Weight	300.17 g/mol (deuterated form)
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic-3,5,6,2',6'-d5 acid, 4-Hydroxy Derivative; 4'-Hydroxy Diclofenac-d4; Diclofenac 4-Hydroxy Metabolite-d4; [2-(2,6-Dichloro-3,5,6,2',6'-pentadeuterophenyl)amino]phenyl]acetic Acid, 4-Hydroxy-; 4-OH Diclofenac-D4; Deuterated 4-Hydroxy Diclofenac; Stable Isotope Labeled 4-Hydroxy Diclofenac.
EINECS	Contact for details

Quality Control

Every batch of 4Hydroxy Diclofenac-D4 (Major) is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity suitable for sensitive analytical applications. Our products undergo rigorous quality testing, including NMR and mass spectrometry, to ensure compliance with industry standards for stable isotope-labeled compounds. Certificates of Analysis (COA) detailing purity, isotopic enrichment, and analytical methods are provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture. For short-term use, store in a desiccator at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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