Description

Parecoxib Impurity 85 is a high-purity 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 Parecoxib Sodium. It is primarily utilized 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 impurities in Parecoxib Sodium API and its formulations.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Parecoxib drug products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D settings to study the degradation pathways and chemical behavior of Parecoxib Sodium.
• Quality Control Testing: Acts as a system suitability standard and a calibrant for routine batch release testing in GMP environments.

Basic Information

Product Name	Parecoxib Impurity 85
CAS No.	36374-51-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound 85; Parecoxib EP Impurity 85; Parecoxib USP Impurity 85; Valdecoxib Impurity; 5-Methyl-3-phenyl-4-isoxazolecarboxylic Acid; 4-Isoxazolecarboxylic acid, 5-methyl-3-phenyl-; 36374-51-3; Valdecoxib Carboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Our Parecoxib Impurity 85 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 product 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 powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.