Description

Valdecoxib 3'-Sulfonyl Chloride Impurity is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of a key synthetic intermediate or degradation product during the manufacture of the COX-2 inhibitor Valdecoxib. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, ensuring drug substance purity and regulatory compliance. The CAS number for this impurity is 1373038-57-3.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC, LC-MS, and GC-MS analysis.
• Quality Control & Assurance: Used for the identification and quantification of the 3'-sulfonyl chloride impurity in Valdecoxib Active Pharmaceutical Ingredient (API) batches.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require characterization and control of known impurities.
• Process Chemistry Research: Employed in studying and optimizing the synthesis pathway of Valdecoxib to minimize the formation of this specific impurity.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Valdecoxib drug products.
• Analytical Method Transfer: Acts as a system suitability test component when transferring impurity testing methods between laboratories or manufacturing sites.

Basic Information

Item	Detail
Product Name	Valdecoxib 3'-Sulfonyl Chloride Impurity
CAS No.	1373038-57-3
Molecular Formula	C16H14ClNO4S
Molecular Weight	351.80 g/mol
Synonyms	1-(4-(Methylsulfonyl)phenyl)-3-(trifluoromethyl)-5-(3-(chlorosulfonyl)phenyl)-1H-pyrazole; Valdecoxib Sulfonyl Chloride Intermediate; Valdecoxib Sulfonyl Chloride Related Compound; 5-(3-(Chlorosulfonyl)phenyl)-1-(4-(methylsulfonyl)phenyl)-3-(trifluoromethyl)-1H-pyrazole; BMS-347070 Sulfonyl Chloride Impurity; 3'-Chlorosulfonyl Valdecoxib Impurity
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib 3'-Sulfonyl Chloride Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications tailored for use as a pharmaceutical reference standard.

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 compound is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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