Description

Celecoxib Impurity CAS NO 915280-81-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Celecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity levels during stability studies and release testing.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Quality Control (QC) & Quality Assurance (QA): Serves as a system suitability standard in routine QC testing to ensure analytical instrument performance and method accuracy.
• Research & Development (R&D): Used in studies to understand the formation, fate, and degradation pathways of impurities during API synthesis and formulation processes.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias such as USP, EP, and BP, where specific impurity limits are defined.

Basic Information

Product Name	Celecoxib Impurity
CAS No.	915280-81-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound; Celecoxib Process Impurity; Celecoxib Degradant; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Specified Impurity; COX-2 Inhibitor Impurity; Celebrex Impurity; SC-58635 Impurity
EINECS	Contact for details

Quality Control

Our Celecoxib Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with GMP, ICH Q3A/B, and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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