Description

Celecoxib Impurity 17 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 pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Celecoxib Impurity 17 in Celecoxib API and finished dosage forms.
• 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: Used as a system suitability standard and for setting impurity acceptance criteria in the routine QC testing of Celecoxib batches.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• 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 pharmaceutical R&D to understand the degradation pathways and impurity profile of Celecoxib during synthesis and formulation.

Basic Information

Product Name	Celecoxib Impurity 17
CAS No.	2247197-65-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 17; Celecoxib EP Impurity I; Celecoxib USP Impurity; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Degradation Product; Celecoxib Process Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 17 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity, and impurities is supplied with each product.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The container should be kept securely sealed to protect the integrity of the standard from moisture and contamination.

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)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.