Description

Valdecoxib Impurity F 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, validation, and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of Valdecoxib-related impurities.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Valdecoxib.
• Critical component for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling.
• Supports pharmacopoeial testing and compliance with standards from USP, EP, and ICH guidelines (Q3A, Q3B).
• Utilized in research and development for synthesizing and studying Valdecoxib analogs and metabolites.

Basic Information

Product Name	Valdecoxib Impurity F
CAS No.	509074-26-4
Molecular Formula	C16H14N2O3S
Molecular Weight	314.36 g/mol
Synonyms	4-(5-Methyl-3-phenyl-4-isoxazolyl)benzenesulfonamide; 4-[5-Methyl-3-phenylisoxazol-4-yl]benzenesulfonamide; Valdecoxib Related Compound F; Valdecoxib Sulfonamide Impurity; BEXTRA Impurity F; SC 65872 Impurity; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Valdecoxib Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results, ensuring compliance with ICH guidelines and meeting the stringent requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (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)	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.