Description

Celecoxib Impurity 24 is a designated chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient Celecoxib. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of Celecoxib-based drug products by enabling accurate identification and quantification of related substances. It is an essential tool for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against ICH Q3A/B thresholds, ensuring batch-to-batch consistency.
• Stability Studies: Employed to identify and track degradation products formed under forced degradation and long-term stability conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing to meet monograph specifications for Celecoxib in USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Celecoxib Impurity 24
CAS No.	2247197-67-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Celecoxib Related Compound 24; Celecoxib EP Impurity I; Celecoxib USP Impurity; 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity; Celecoxib Degradant; Celecoxib Process Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Celecoxib Impurity 24 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference materials, supporting compliance with cGMP, ICH, and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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