Description

Parecoxib Impurity K is a designated impurity of the active pharmaceutical ingredient Parecoxib Sodium, a selective COX-2 inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Parecoxib drug substances and finished products. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments to ensure product safety, efficacy, 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 K in Parecoxib Sodium API and related formulations.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Research on Degradation Pathways: Aids in elucidating the chemical degradation mechanisms of Parecoxib, supporting formulation optimization.

Basic Information

Item	Details
Product Name	Parecoxib Impurity K
CAS No.	198471-69-1
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Valdecoxib Impurity K; 5-Methyl-3-phenyl-4-[(phenylsulfonyl)amino]isoxazole; 4-[(4-Methylphenyl)sulfonyl]amino]-5-methyl-3-phenylisoxazole; Parecoxib Related Compound K; Parecoxib EP Impurity K; Parecoxib USP Impurity K; Valdecoxib Related Compound K
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic techniques. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a desiccator to maintain stability.

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: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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