Description

Parecoxib Impurity 61 is a designated impurity standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Parecoxib Sodium. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Parecoxib Sodium API and its formulations.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity profiling and control strategies.
• Pharmacopoeial Testing: Supports testing to meet the requirements of pharmacopoeias such as USP, EP, or JP where Parecoxib monographs are established.

Basic Information

Product Name	Parecoxib Impurity 61
CAS No.	35282-78-1
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Parecoxib Related Compound 61; 5-Methyl-3-phenyl-4-isoxazolecarboxylic Acid, 4-(5-Methyl-3-phenyl-4-isoxazolyl)benzenesulfonamide Derivative; Valdecoxib Impurity; SC-66905 Impurity; COX-2 Inhibitor Impurity; Parecoxib Sodium Impurity 61; 4-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonamide Related Substance
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity 61 is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing batch-specific results and traceability.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and analytical performance.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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