Description

Parecoxib Impurity T is a designated impurity reference standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Parecoxib Sodium. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Parecoxib Sodium drug substance and drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurities during the manufacturing process.
• Stability Studies: Used to track the formation and levels of this specific impurity in Parecoxib formulations under various storage conditions over time.
• Quality Control & Release Testing: A critical component in the batch release testing of Parecoxib Sodium to ensure it meets pharmacopeial (e.g., USP, EP) or internal specification limits for related substances.
• Regulatory Compliance and Filings: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity characterization data to health authorities like the FDA and EMA.
• Research and Development: Used in R&D to understand the degradation pathways and impurity profile of Parecoxib, aiding in process improvement and formulation science.

Basic Information

Item	Details
Product Name	Parecoxib Impurity T
CAS No.	198471-83-9
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Parecoxib Related Compound T; 5-Fluoro-2-methyl-1-[4-(methylsulfonyl)phenyl]-1H-indole-3-acetic acid; SC 70935 Impurity; Valdecoxib Impurity; Dynastat Impurity; COX-2 Inhibitor Impurity; Parecoxib Sodium Impurity T
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity T is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile.

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 should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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