Description

Celecoxib Impurity 2 is a designated process-related impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Celecoxib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of the final drug product. It is primarily used by R&D scientists, quality assurance professionals, and regulatory affairs specialists in the pharmaceutical industry for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Celecoxib Impurity 2 in Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Used as a system suitability standard in routine QC testing to confirm the performance of chromatographic systems for impurity analysis.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for Drug Master Files (DMFs) and Common Technical Documents (CTD).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Celecoxib to minimize the formation of this impurity.

Basic Information

Product Name	Celecoxib Impurity 2
CAS No.	948293-46-7
Molecular Formula	C17H14F3N3O2S
Molecular Weight	405.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound 2; Celecoxib EP Impurity B; Celecoxib USP Related Compound B; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole; Celecoxib Impurity B (EP); Celecoxib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 2 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization using advanced techniques including HPLC, GC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against stringent in-house specifications aligned with pharmacopeial expectations (USP/EP). Our quality assurance protocols ensure traceability and consistency for critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. Keep away from heat and incompatible materials.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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