Description

Parecoxib Sodium Impurity D is a high-purity chemical reference standard critical for analytical and regulatory purposes in pharmaceutical development. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Parecoxib Sodium by serving as a known impurity for method validation and control. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in the synthesis, analysis, and regulatory filing of COX-2 inhibitor drugs.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Impurity D in Parecoxib Sodium API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC testing to ensure Parecoxib Sodium batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to monitor the formation and level of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Utilized in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during the API manufacturing process.

Basic Information

Item	Detail
Product Name	Parecoxib Sodium Impurity D
CAS No.	198470-92-7
Molecular Formula	C19H17N2O4S2Na
Molecular Weight	432.47 g/mol
Synonyms	Parecoxib Sodium Related Compound D; 5-Methyl-3,4-diphenylisoxazol-4'-yl)methanesulfonate Sodium Salt Impurity D; 4-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonamide, N-[[(4-methylphenyl)sulfonyl]oxy]-, Sodium Salt; Valdecoxib Sulfamate Ester Sodium Salt; SC 66901 Impurity D; Dynastat Impurity D
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Sodium Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for reference materials, including identity confirmation, purity verification, and impurity profiling. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques such as HPLC, NMR, and MS. We support compliance with ICH, USP, and EP guidelines.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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