Description

Parecoxib Impurityo is a designated impurity associated with the active pharmaceutical ingredient Parecoxib Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is essential for quality control laboratories and manufacturers to ensure the purity, safety, and efficacy of Parecoxib Sodium drug substances and products. Its primary use is in the identification, quantification, and control of this specific impurity during the synthesis and production of the parent drug.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Critical for identifying and characterizing Parecoxib Impurityo in Parecoxib Sodium bulk drug and finished dosage forms.
• Method Development & Validation: Serves as a key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and increase of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Parecoxib Sodium, helping to optimize processes to minimize impurity formation.

Basic Information

Product Name	Parecoxib Impurityo
CAS No.	198470-91-6
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Parecoxib Related Compound O; 5-Methyl-3-phenyl-4-[(5-methyl-3-phenylisoxazol-4-yl)methanesulfonyl]isoxazole; Parecoxib Sulfone Impurity; Parecoxib Sulfone; SC 69124A Sulfone; Dynastat Impurity O; Valdecoxib Prodrug Impurity; (5-Methyl-3-phenylisoxazol-4-yl)[(5-methyl-3-phenyl-4-isoxazolyl)methyl] sulfone
EINECS	Contact for details

Quality Control

Our Parecoxib Impurityo is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide full traceability and Certificates of Analysis (COA) that detail all test results against predefined specifications. Our quality standards align with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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.