Description

Valdecoxib Impurity D is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Valdecoxib. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Valdecoxib active pharmaceutical ingredients (APIs) and finished drug products. This high-purity impurity standard is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Valdecoxib Impurity D in API and drug product testing.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities in Valdecoxib batches.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Valdecoxib API and formulations meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• 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 and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough characterization and control of the impurity profile of Valdecoxib.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during Valdecoxib synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Valdecoxib Impurity D
CAS No.	181696-35-5
Molecular Formula	C16H14N2O3S
Molecular Weight	314.36 g/mol
Synonyms	4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide; Valdecoxib Related Compound D; Valdecoxib Sulfonamide Impurity; BMS-347070 Impurity D; SC-65872 Impurity; COX-2 Inhibitor Impurity D; 4-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonamide
EINECS	Contact for details

Quality Control

Our Valdecoxib Impurity D 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 a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference standards and support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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