Description

Celecoxib Trifluro Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Celecoxib. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Celecoxib drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection.
• Stability Studies: Employed in forced degradation and long-term stability studies of Celecoxib to monitor the formation of this impurity under various stress conditions.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch release testing in pharmaceutical manufacturing to ensure impurities are within ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Celecoxib-related substances.

Basic Information

Product Name	Celecoxib Trifluro Impurity
CAS No.	910303-54-7
Molecular Formula	C17H14F3N3O2S
Molecular Weight	405.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Trifluoro Impurity; Celecoxib Related Compound; Celecoxib Sulfonamide Impurity; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole; Celecoxib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of our Celecoxib Trifluro Impurity is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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