Description

Diclofenac-D4 Sodium Salt (Phenyl-D4-Acetic) CAS NO 154523-54-3 is a high-purity, deuterium-labeled internal standard essential for precise quantitative analysis in bioanalytical and pharmacokinetic studies. This stable isotope-labeled compound is critical for ensuring analytical accuracy and reliability in mass spectrometry, eliminating matrix effects and providing robust calibration. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and bioequivalence studies for the non-steroidal anti-inflammatory drug (NSAID) diclofenac.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference standard in the bioanalysis of diclofenac and its metabolites in biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME).
• Drug Metabolism Research: Facilitates the identification and quantification of metabolite formation pathways in in vitro and in vivo studies.
• Bioequivalence Testing: Critical for generic drug development, ensuring analytical methods meet regulatory standards for comparing test and reference formulations.
• Clinical Trial Support: Provides reliable data for monitoring drug levels in patients during clinical phases of drug development.
• Forensic and Doping Control Analysis: Supports accurate detection and quantification of diclofenac in forensic toxicology and anti-doping programs.

Basic Information

Product Name	Diclofenac-D4 Sodium Salt (Phenyl-D4-Acetic)
CAS No.	154523-54-3
Molecular Formula	C14H7D4Cl2NNaO2
Molecular Weight	322.15 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic-2,3,5,6-d4 acid sodium salt; Sodium [2-[(2,6-dichlorophenyl)amino]phenyl-d4]acetate; Diclofenac-d4 Na; Diclofenac Sodium-d4; [phenyl-d4]-Diclofenac Sodium Salt; Deuterated Diclofenac Sodium Salt; Diclofenac (phenyl-D4) Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Diclofenac-D4 Sodium Salt is manufactured and tested under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment supports compliance with GMP and ISO guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure (D4-label confirmed)
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (MS)	≥98.0 atom % D
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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