Description

Parecoxib Impurity 16 is a high-purity chemical 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 research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Parecoxib Sodium API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to ensure product purity and compliance with ICH guidelines.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in academic and industrial R&D for studying the metabolism, degradation pathways, and synthesis of Parecoxib and related compounds.

Basic Information

Product Name	Parecoxib Impurity 16
CAS No.	2235371-89-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound 16; Parecoxib EP Impurity 16; Parecoxib USP Impurity 16; Parecoxib Sodium Impurity 16; 4-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonamide Impurity; Dynastat Impurity 16; SC 69124A Impurity; COX-2 Inhibitor Impurity; Valdecoxib Prodrug Impurity
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, MS, NMR, IR) 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment. 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 standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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