Celecoxib-d7 | CAS 544686-21-7

Celecoxib-d7 (CAS No. 544686-21-7) is a stable isotope-labeled analogue of celecoxib in which seven hydrogen atoms are replaced with deuterium (²H). This isotopically labeled reference standard is extensively used in pharmaceutical research, bioanalytical method development, pharmacokinetic (PK) studies, therapeutic drug monitoring, and forensic toxicology. Due to its nearly identical physicochemical properties to native celecoxib while being distinguishable by mass spectrometry, Celecoxib-d7 serves as an ideal internal standard for accurate and reproducible quantification using LC-MS/MS and GC-MS analytical platforms.

At ResolveMass Laboratories Inc., we provide comprehensive analytical support for stable isotope-labeled reference standards, including method development, method validation, impurity profiling, bioanalytical assay development, and quantitative mass spectrometry for pharmaceutical and clinical research applications.

Product Overview

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor widely prescribed for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, and familial adenomatous polyposis. During bioanalysis, highly accurate quantification of celecoxib in biological matrices requires an internal standard that compensates for extraction variability, ion suppression, and instrument fluctuations.

Celecoxib-d7 fulfills this requirement because it co-elutes with native celecoxib during chromatographic separation while producing a distinct mass transition in the mass spectrometer. This significantly improves analytical accuracy, precision, and reproducibility across regulated bioanalytical studies. Stable isotope-labeled internal standards such as Celecoxib-d7 are widely recognized as the preferred approach for quantitative LC-MS/MS assays.

Chemical Information

Specifications may vary slightly depending on production batch.

Key Features

• Stable isotope-labeled analogue of celecoxib
• Excellent internal standard for LC-MS/MS quantification
• High isotopic enrichment
• High chemical purity
• Minimal isotope exchange during analysis
• Excellent chromatographic co-elution with native celecoxib
• Suitable for regulated bioanalytical studies
• Compatible with GLP and GMP analytical workflows
• Ideal for pharmacokinetic and bioequivalence studies
• Supports highly sensitive quantitative mass spectrometry

Applications

Celecoxib-d7 is routinely used across pharmaceutical development, clinical research, and analytical laboratories.

LC-MS/MS Bioanalysis

The primary application of Celecoxib-d7 is as an internal standard during quantitative LC-MS/MS analysis of celecoxib in plasma, serum, urine, tissues, and other biological matrices. Because the labeled compound behaves almost identically to the analyte during sample preparation and chromatography, it effectively corrects for analytical variability and improves assay robustness.

Pharmacokinetic Studies

Celecoxib-d7 is extensively employed during pharmacokinetic investigations to quantify drug concentrations throughout absorption, distribution, metabolism, and elimination studies. Accurate quantification is essential for determining:

• Cmax
• Tmax
• AUC
• Clearance
• Half-life
• Volume of distribution

Bioequivalence Studies

Generic drug manufacturers rely on validated LC-MS/MS methods using isotope-labeled internal standards to demonstrate bioequivalence between generic and reference celecoxib formulations. Celecoxib-d7 enhances assay precision while meeting global regulatory expectations for bioanalytical method validation.

Clinical Research

Clinical laboratories use Celecoxib-d7 for therapeutic drug monitoring, clinical pharmacology investigations, dose optimization studies, and patient compliance assessments.

Pharmaceutical Method Development

Analytical scientists employ Celecoxib-d7 during:

• Method development
• Method optimization
• Method transfer
• Method validation
• Cross-validation studies
• Routine quality control

Toxicology and Forensic Analysis

Sensitive analytical methods incorporating Celecoxib-d7 are also used in toxicological investigations and forensic laboratories for reliable detection and quantification of celecoxib.

Advantages of Using Celecoxib-d7

Stable isotope-labeled internal standards provide several analytical advantages over structural analogues.

Improved Accuracy

Celecoxib-d7 compensates for variations during sample extraction, evaporation, and instrument response, resulting in improved quantitative accuracy.

Reduced Matrix Effects

Biological matrices often produce ion suppression or ion enhancement during LC-MS/MS analysis. Because Celecoxib-d7 co-elutes with native celecoxib, both compounds experience nearly identical matrix effects, enabling more reliable quantification.

Excellent Precision

Use of a deuterated internal standard significantly improves inter-day and intra-day precision across multiple analytical batches.

Regulatory Acceptance

Stable isotope-labeled internal standards are widely accepted for regulated bioanalytical assays conducted according to FDA, EMA, and ICH bioanalytical validation expectations, making Celecoxib-d7 a preferred choice for compliant quantitative methods.

Analytical Techniques Supported

Celecoxib-d7 is compatible with numerous analytical platforms, including:

• LC-MS/MS
• UHPLC-MS/MS
• LC-HRMS
• GC-MS
• Triple Quadrupole Mass Spectrometry
• Orbitrap HRMS
• QTOF Mass Spectrometry

These techniques enable highly selective and sensitive quantification across pharmaceutical research and regulated laboratory environments.

Quality Considerations

High-quality isotope-labeled standards are essential for generating reproducible analytical data. Key quality attributes include:

• High isotopic enrichment
• High chemical purity
• Structural identity confirmation
• Minimal unlabeled impurity
• Batch-to-batch consistency
• Long-term stability under recommended storage conditions

Each batch should be supported by appropriate analytical documentation, including identity confirmation using NMR and mass spectrometry, along with purity assessment by chromatographic methods.

ResolveMass Laboratories Analytical Expertise

ResolveMass Laboratories Inc. supports pharmaceutical and biotechnology organizations through advanced analytical services involving stable isotope-labeled reference standards and quantitative mass spectrometry.

Our capabilities include:

• LC-MS/MS method development
• Bioanalytical method validation
• Pharmacokinetic sample analysis
• Stable isotope-labeled internal standard qualification
• Extractables and leachables analysis
• Impurity characterization
• High-resolution mass spectrometry
• Forced degradation studies
• Regulatory-compliant analytical documentation
• Custom analytical method development

Our experienced analytical scientists develop robust, reproducible, and regulatory-compliant methods designed to support drug discovery, preclinical studies, clinical development, generic drug programs, and commercial manufacturing.

Why Choose ResolveMass Laboratories?

ResolveMass Laboratories combines scientific expertise with advanced analytical instrumentation to deliver high-quality pharmaceutical testing solutions. Our laboratories support complex quantitative analyses using isotope-labeled reference standards while maintaining strict quality systems and scientifically sound analytical practices.

Whether your project involves bioanalysis, pharmacokinetics, method validation, or reference standard characterization, our team provides reliable analytical support tailored to your development program.

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