Description

Celecoxib Impurity 18 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Celecoxib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Celecoxib Impurity 18 in Celecoxib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Serves as a system suitability standard and for preparing calibration curves to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., FDA, EMA) by providing necessary impurity characterization and control data in Common Technical Documents (CTD).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in R&D to study the degradation pathways of Celecoxib and to synthesize purer API batches by understanding impurity formation.

Basic Information

Product Name	Celecoxib Impurity 18
CAS No.	2271123-54-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 18; Celecoxib EP Impurity 18; Celecoxib USP Impurity 18; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Degradation Product; Celecoxib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. 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 in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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