Description

Celecoxib Impurity-G is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Celecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The use of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Celecoxib Impurity-G in Celecoxib API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control this specific impurity.
• Stability Studies & Forced Degradation: Employed to understand the degradation pathways of Celecoxib and to establish appropriate shelf-life and storage conditions.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Celecoxib to ensure every batch meets predefined impurity limits as per ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity profiles, supporting the safety and efficacy of the drug product.
• Research & Development: Used in R&D to study the synthesis, formation mechanism, and toxicological profile of this impurity.

Basic Information

Product Name	Celecoxib Impurity-G
CAS No.	1061214-06-9
Molecular Formula	C17H14F3N3O2S
Molecular Weight	381.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide; Celecoxib Related Compound G; Celecoxib EP Impurity G; Celecoxib USP Impurity G; Celecoxib Process Impurity; Celecoxib Degradant; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity-G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 storing under an inert atmosphere.

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 ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.