Description

Celecoxib Impurity 1 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Celecoxib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Celecoxib Impurity 1 in Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Celecoxib API meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Facilitates impurity characterization, synthesis pathway optimization, and degradation studies during the drug development process.

Basic Information

Product Name	Celecoxib Impurity 1
CAS No.	54779-81-6
Molecular Formula	C17H14F3N3O2S
Molecular Weight	381.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound A; Celecoxib Sulfonamide Impurity; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole; Celecoxib EP Impurity A; Celecoxib USP Related Compound A; Celecoxib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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