Description

Valdecoxib Impurity B is a specified impurity 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 and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs departments to ensure drug purity, safety, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Valdecoxib Impurity B in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure Valdecoxib batches meet the specified impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submission & Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Valdecoxib.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Valdecoxib to minimize impurity formation.

Basic Information

Product Name	Valdecoxib Impurity B
CAS No.	1373038-60-8
Molecular Formula	C16H14N2O3S
Molecular Weight	314.36 g/mol
Synonyms	4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide; Valdecoxib Related Compound B; Valdecoxib Sulfonamide Impurity; BMS-347070 Impurity B; COX-2 Inhibitor Impurity; 4-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonamide
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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 impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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