Description

Valdecoxib Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Valdecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Valdecoxib drug substance and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this impurity during forced degradation and long-term stability testing of pharmaceutical formulations.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Chemical Research: Used in academic and industrial research to study the degradation pathways and metabolism of Valdecoxib.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product purity and safety.

Basic Information

Product Name	Valdecoxib Impurity 18
CAS No.	2304623-42-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valdecoxib Related Compound 18; Valdecoxib EP Impurity 18; Valdecoxib USP Impurity 18; Valdecoxib Degradation Product; 4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide Impurity; BEXTRA Impurity 18; COX-2 Inhibitor Impurity; 2304623-42-3
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
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)	≤ 1.0% w/w

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