Description

Celecoxib Impurity 21 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, qualification, and control of process-related impurities in the active pharmaceutical ingredient Celecoxib, a widely used COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). It is an essential material for analytical chemists and quality control laboratories in pharmaceutical companies and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of specific impurities during Celecoxib API development and manufacturing.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for Celecoxib.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines in commercial Celecoxib batches.
• Stability Studies: Used to track the formation of this specific impurity under various forced degradation and long-term stability conditions for Celecoxib drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and justify specifications.
• Research and Development: Facilitates studies on impurity formation pathways, helping to optimize synthetic routes and purification processes for Celecoxib.

Basic Information

Product Name	Celecoxib Impurity 21
CAS No.	2055787-31-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 21; Celecoxib EP Impurity I; Celecoxib USP Impurity; Celecoxib Process Impurity; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.