Description

Celecoxib Impurity 23 CAS NO 2247197-66-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Celecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Celecoxib drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Celecoxib batches meet pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in R&D to study the degradation pathways and chemical behavior of Celecoxib.

Basic Information

Product Name	Celecoxib Impurity 23
CAS No.	2247197-66-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 23; Celecoxib EP Impurity 23; Celecoxib USP Impurity 23; Celecoxib Process Impurity; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Degradant; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Celecoxib Impurity 23 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (e.g., by NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH guidelines and supports compliance with global regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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