Description

n-De(4-Sulfonamidophenyl)-Na€-[4-Sulfonamido(Phenyl-D4)] Celecoxib is a deuterated analog of the selective COX-2 inhibitor celecoxib, designed for advanced pharmaceutical research and development. This compound matters as a critical internal standard and reference material in bioanalytical method development, enabling precise quantification and metabolic studies through mass spectrometry. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetics, drug metabolism, and stability testing for next-generation anti-inflammatory therapeutics.

Application

• Bioanalytical Reference Standard: Serves as a stable isotope-labeled internal standard for the accurate quantification of celecoxib and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in tracer studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of celecoxib.
• Pharmaceutical Impurity Profiling: Acts as a marker in the development and validation of analytical methods to identify and quantify potential deuterated impurities or related substances.
• Clinical Research Support: Essential for ensuring data integrity and regulatory compliance in bioequivalence and clinical trial studies involving celecoxib-based formulations.
• Metabolite Identification: Aids in the structural elucidation of celecoxib metabolites by providing a definitive mass spectrometric signature.
• Method Development and Validation: Provides a critical tool for scientists developing robust, sensitive, and specific analytical procedures compliant with ICH and FDA guidelines.

Basic Information

Product Name	n-De(4-Sulfonamidophenyl)-Na€-[4-Sulfonamido(Phenyl-D4)] Celecoxib
CAS No.	1346604-14-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib-d4 (sulfonamide phenyl-d4 analog); Deuterated Celecoxib Sulfonamide; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide-d4 (sulfonamide phenyl-d4); Celecoxib Internal Standard-d4; Celecoxib-d4 (sulfonamide labeled); COX-2 Inhibitor-d4; SC-58635-d4 (sulfonamide phenyl-d4)
EINECS	Contact for details

Quality Control

Our deuterated pharmaceutical standards are manufactured under strict quality management systems. Each batch undergoes comprehensive analysis to ensure high chemical purity, isotopic enrichment, and structural integrity. Certificates of Analysis (COA) are provided, detailing results from NMR, HPLC, and mass spectrometry. We support compliance with ICH Q2(R1) guidelines for analytical method validation, making this material suitable for regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated area. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
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.