Description

Valdecoxib 3'-Sulfonamide Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality and safety of pharmaceutical products by serving as a key marker for impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality control of the COX-2 inhibitor, Valdecoxib.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor the 3'-Sulfonamide impurity in Valdecoxib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to ensure accurate detection and quantification limits for this specific impurity.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and a calibrant in routine QC testing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities in new drug substances and products.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation for agencies like the FDA and EMA by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation and level of this degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's formation pathways and potential impact.

Basic Information

Item	Detail
Product Name	Valdecoxib 3'-Sulfonamide Impurity
CAS No.	1373038-56-2
Molecular Formula	C16H14N2O4S
Molecular Weight	330.36 g/mol
Synonyms	3'-Sulfonamide Valdecoxib Impurity; Valdecoxib 3'-Sulfonamide Related Compound; 4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide; N-[4-(5-Methyl-3-phenylisoxazol-4-yl)phenyl]sulfonamide; BMS-347070 3'-Sulfonamide Impurity; Valdecoxib Sulfonamide Analog; Valdecoxib EP Impurity; Valdecoxib USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib 3'-Sulfonamide Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain 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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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