Description

Parecoxib Impurity CAS NO 2749361-92-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Parecoxib Sodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Parecoxib Sodium drug substance and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical production to ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Parecoxib formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Parecoxib.

Basic Information

Item	Detail
Product Name	Parecoxib Impurity
CAS No.	2749361-92-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound; Parecoxib Sodium Impurity; Parecoxib Degradation Product; Parecoxib Process Impurity; Specific Parecoxib Impurity; 2749361-92-8; (Compound related to N-[[4-(5-Methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]propanamide)
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity CAS NO 2749361-92-8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Related Substances (HPLC)	Individual 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.