Description

Valdecoxib Impurity 9 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Valdecoxib through rigorous analytical control. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance testing. The availability of this well-characterized impurity is essential for meeting stringent global regulatory requirements for drug substance and drug product specifications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Valdecoxib Impurity 9 in Valdecoxib API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, precision, and detection/quantitation limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Valdecoxib.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process.

Basic Information

Product Name	Valdecoxib Impurity 9
CAS No.	1037546-03-4
Molecular Formula	C16H14N2O3S
Molecular Weight	314.36 g/mol
Synonyms	Valdecoxib Related Compound 9; 4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide Impurity 9; BMS-347070 Impurity 9; 1,2-Benzisoxazole-3-methanesulfonamide, 5,6-dihydro-5,5-dimethyl-; Valdecoxib EP Impurity I; Valdecoxib USP Impurity; Valdecoxib Process Impurity
EINECS	Contact for details

Quality Control

Our Valdecoxib Impurity 9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and impurity profile. The quality control protocols are designed to comply with relevant ICH guidelines and current Good Manufacturing Practices (cGMP). Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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