Description

Celecoxib Impurity 22 is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient Celecoxib. This compound is critical for ensuring the purity, safety, and efficacy of Celecoxib formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Celecoxib Impurity 22 in Celecoxib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurities during stability studies.
• Quality Control & Batch Release Testing: Employed in routine QC labs to confirm that Celecoxib batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Acts as a marker to track the formation of this specific impurity under various stress conditions (heat, light, humidity).
• Research & Development: Utilized in R&D to study the degradation pathways and chemistry of Celecoxib.

Basic Information

Product Name	Celecoxib Impurity 22
CAS No.	36966-84-4
Molecular Formula	C17H14F3N3O2S
Molecular Weight	381.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound 22; Celecoxib EP Impurity H; Celecoxib USP Related Compound A; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole; Celecoxib Degradant
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 22 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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