Description

Parecoxib Impurity 4 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Parecoxib Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Parecoxib Impurity 4 in Parecoxib Sodium API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor impurity levels and ensure they are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing necessary impurity characterization data for agencies like the FDA and EMA.
• Research on Degradation Pathways: Used in research to understand the chemical degradation mechanisms of Parecoxib, aiding in the formulation of more stable drug products.

Basic Information

Product Name	Parecoxib Impurity 4
CAS No.	57736-10-4
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Valdecoxib Impurity D; 4-(5-Methyl-3-phenyl-4-isoxazolyl)benzenesulfonamide; Parecoxib Related Compound D; SC 66901; Parecoxib Sulfonamide Impurity; Valdecoxib Sulfonamide Impurity; 5-Methyl-3-phenyl-4-[4-(sulfamoyl)phenyl]isoxazole
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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 under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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