Description

Celecoxib Impurity 20 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Celecoxib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Celecoxib batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Celecoxib, supporting formulation optimization and packaging selection.

Basic Information

Product Name	Celecoxib Impurity 20
CAS No.	343853-74-7
Molecular Formula	C17H14F3N3O2S
Molecular Weight	405.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound 20; Celecoxib EP Impurity J; Celecoxib USP Related Compound A (Check specific nomenclature); Celecoxib Degradant; Celecoxib Process Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Celecoxib Impurity 20 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents. The material is suitable for use as a reference standard in compliance with ICH Q3A(R2), Q3B(R2), and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material should be handled under appropriate conditions to prevent contamination or degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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