Description

Rofecoxib CAS NO 162011-90-7 is a selective cyclooxygenase-2 (COX-2) inhibitor, a well-known nonsteroidal anti-inflammatory drug (NSAID) compound. It serves as a critical reference standard and active pharmaceutical ingredient (API) for research and analytical purposes in the pharmaceutical development sector. This compound is essential for laboratories and manufacturers involved in method development, quality control, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the identification, assay, and impurity profiling of related drug products in quality control laboratories.
• Analytical Research: Employed in method development and validation for HPLC, LC-MS, and other chromatographic techniques in academic and industrial research settings.
• Pharmacological Studies: Serves as a key compound in preclinical and clinical research to study COX-2 inhibition mechanisms, inflammation pathways, and drug metabolism.
• Impurity Synthesis and Characterization: Used to synthesize and qualify potential degradation products and process-related impurities for regulatory filings (e.g., ICH guidelines).
• Bioanalytical Applications: Acts as a calibrant or internal standard in bioequivalence studies and pharmacokinetic analysis within contract research organizations (CROs).
• Educational and Training Material: Supplied to universities and training institutes for educational purposes in medicinal chemistry and pharmaceutical analysis courses.

Basic Information

Product Name	Rofecoxib
CAS No.	162011-90-7
Molecular Formula	C17H14O4S
Molecular Weight	314.36 g/mol
Synonyms	Vioxx; MK-0966; 4-[4-(Methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone; 3-Phenyl-4-[4-(methylsulfonyl)phenyl]-2(5H)-furanone; L-748731; COX-2 Inhibitor II; Rofecoxibum
EINECS	Contact for details

Quality Control

Our Rofecoxib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and mass spectrometry. We provide full traceability and Certificates of Analysis (COA) are supplied with every shipment, ensuring compliance with research and pharmaceutical-grade standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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