Description

Celecoxib Impurity CAS NO 170570-09-9 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for the accurate identification, quantification, and monitoring of specific impurities during the manufacturing and stability testing of the active pharmaceutical ingredient (API) Celecoxib. It is an essential tool for analytical chemists and quality assurance professionals working to ensure drug safety, efficacy, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific process-related impurities or degradation products in Celecoxib API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods for Celecoxib.
• Quality Control (QC) Testing: Employed in routine batch release testing of Celecoxib raw materials and finished dosage forms to ensure impurity levels meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to monitor the formation of degradation impurities in Celecoxib under various stress conditions (e.g., heat, light, humidity) as part of ICH stability-indicating studies.
• Regulatory Submissions: Provides essential data and characterization for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate control over the impurity profile of Celecoxib.
• Research and Development: Utilized in synthetic chemistry R&D to understand and optimize the Celecoxib manufacturing process, aiming to minimize the formation of this specific impurity.

Basic Information

Product Name	Celecoxib Impurity
CAS No.	170570-09-9
Molecular Formula	C17H14F3N3O2S
Molecular Weight	381.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound; Celecoxib Sulfonamide Impurity; Celecoxib Process Impurity; SC-58635 Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity (CAS 170570-09-9) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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