Description

Parecoxib Impurity 12 is a high-purity chemical reference standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Parecoxib Sodium. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams focused on method validation and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Parecoxib Impurity 12 in Parecoxib Sodium API and its formulations.
• Analytical Method Development & Validation: Used in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Parecoxib.
• Quality Control & Batch Release Testing: Critical for routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency of the API.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize the manufacturing process of Parecoxib.

Basic Information

Product Name	Parecoxib Impurity 12
CAS No.	2229657-81-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound 12; Parecoxib EP Impurity 12; Parecoxib USP Impurity 12; Parecoxib Degradation Product; Valdecoxib Impurity; COX-2 Inhibitor Impurity; SC 69124 Impurity; (5-Methyl-3-phenyl-4-isoxazolyl)[4-(methylsulfonyl)phenyl]methanone Impurity
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP, ICH). 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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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