Description

Parecoxib Impurity 24 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 pharmaceutical product Parecoxib Sodium. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of the active pharmaceutical ingredient (API) Parecoxib Sodium.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for accurate impurity quantification.
• Stability Studies and Forced Degradation: Employed to identify and monitor this specific impurity in stability-indicating assays to determine drug product shelf-life.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Research and Development: Used in R&D laboratories to study the formation pathway, chemical properties, and toxicological significance of this impurity.
• Pharmacopeial Testing: Applied as a system suitability component in testing to comply with monographs from USP, EP, or other pharmacopeias.

Basic Information

Product Name	Parecoxib Impurity 24
CAS No.	198471-07-7
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Parecoxib Related Compound 24; Parecoxib EP Impurity D; Valdecoxib Impurity; 5-Methyl-3-phenyl-4-[(5-methyl-3-phenyl-4-isoxazolyl)methoxy]isoxazole; SC-66901 Impurity; COX-2 Inhibitor Impurity; Parecoxib Sodium Impurity 24
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity 24 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, GC, and NMR to ensure compliance with pharmacopeial standards. 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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≤ 1.0%

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