Description

Celecoxib Impurity 22 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Celecoxib during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and regulatory compliance. The availability of well-characterized impurities like this is essential for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Celecoxib API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications to ensure batch-to-batch consistency.
• Regulatory Compliance & Submission: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies as per ICH guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Utilized in pharmaceutical R&D to understand degradation pathways and to synthesize impurity-free API.

Basic Information

Product Name	Celecoxib Impurity 22
CAS No.	921617-76-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 22; Celecoxib EP Impurity J; Celecoxib USP Impurity; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Degradation Product; Celecoxib Process Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Celecoxib Impurity 22 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the requirements of major pharmacopeias (USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 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.